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Wang Y, Pan Y, Xiao Y, Yang J, Wu H, Chen Y. Effectiveness of Roux-en-Y Gastric Bypass in Patients with Type 2 Diabetes: A Meta-analysis of Randomized Controlled Trials. Obes Surg 2025; 35:1109-1122. [PMID: 39891839 DOI: 10.1007/s11695-025-07698-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2024] [Revised: 01/14/2025] [Accepted: 01/16/2025] [Indexed: 02/03/2025]
Abstract
This meta-analysis aimed to evaluate the effectiveness of Roux-en-Y gastric bypass (RYGB) in people living with type 2 diabetes mellitus (T2DM). A comprehensive search was conducted in the PubMed database up to January 2024. A random-effects model was used to calculate the pooled standard mean differences (SMDs) and odds ratios (ORs). Ten studies were included in our review. The RYGB group demonstrated significantly better outcomes compared to the non-surgical group in multiple measures. These included higher triple criteria compliance rates (OR 9.04, 95% CI 3.22-25.36), complete T2DM remission (OR 15.37, 95% CI 4.42-53.41), and partial T2DM remission (OR 11.49, 95% CI 3.57-37.03). Additionally, improvements were observed in glycated hemoglobin A1c (HbA1c) levels (SMD - 1.41, 95% CI - 2.22 to - 0.61), with HbA1c < 6.0% (OR 8.54, 95% CI 3.38-21.62) and HbA1c < 7.0% (OR 5.62, 95% CI 3.20-9.86). Fasting blood glucose (FBG) levels also showed improvement (SMD - 0.43, 95% CI - 0.71 to - 0.14), with a higher proportion achieving FBG < 100 mg/dl (OR 11.83, 95% CI 4.75-29.43). Other notable outcomes included significant percentage of total weight loss (%TWL: SMD 1.88, 95% CI 1.39-2.37), reductions in body mass index (BMI: SMD - 2.28, 95% CI - 3.52 to - 1.04), and improvements in lipid profiles, including low-density lipoprotein (LDL) levels (SMD - 1.01, 95% CI - 1.91 to - 0.11) and LDL < 2.59 mmol/L (OR 3.65, 95% CI 1.94-6.87). In addition, high-density lipoprotein (HDL) levels increased (SMD 1.30, 95% CI 0.55-2.05), while triglycerides (SMD - 1.11, 95% CI - 1.70 to - 0.52), systolic blood pressure (SBP: SMD - 0.38, 95% CI - 0.70 to - 0.06), and diastolic blood pressure (DBP: SMD - 0.41, 95% CI - 0.63 to - 0.18) decreased. A greater proportion of patients in the RYGB group achieved SBP < 130 mmHg (OR 3.15, 95% CI 1.61-6.13). Moreover, reductions were noted in insulin use (OR 0.25, 95% CI 0.14-0.46), diabetes medication use (SMD - 1.95, 95% CI - 3.32 to - 0.57), and peripheral neuropathy (OR 0.13, 95% CI 0.02-0.79). However, no significant differences were observed in hypertension medication use or retinopathy between the two groups. RYGB was found to be effective in improving glycemic control, promoting weight loss, enhancing lipid profiles, and managing blood pressure. It also significantly reduced the need for postoperative diabetes medications and the incidence of diabetic peripheral neuropathy in people living with T2DM.
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Affiliation(s)
- Yao Wang
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China.
| | - Yan Pan
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
| | - Yibo Xiao
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
| | - Jingxian Yang
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
| | - Haoming Wu
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
| | - Yingying Chen
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
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Tomić M, Vrabec R, Ljubić S, Prkačin I, Bulum T. Patients with Type 2 Diabetes, Higher Blood Pressure, and Infrequent Fundus Examinations Have a Higher Risk of Sight-Threatening Retinopathy. J Clin Med 2024; 13:2496. [PMID: 38731024 PMCID: PMC11084692 DOI: 10.3390/jcm13092496] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2024] [Revised: 03/28/2024] [Accepted: 04/21/2024] [Indexed: 05/13/2024] Open
Abstract
Background: Diabetic retinopathy (DR) is the most common cause of preventable blindness among working-age adults. This study aimed to evaluate the impact of the regularity of fundus examinations and risk factor control in patients with type 2 diabetes (T2DM) on the prevalence and severity of DR. Methods: One hundred and fifty-six T2DM patients were included in this cross-sectional study. Results: In this sample, the prevalence of DR was 46.2%. Patients with no DR mainly did not examine the fundus regularly, while most patients with mild/moderate nonproliferative DR (NPDR) underwent a fundus examination regularly. In 39.7% of patients, this was the first fundus examination due to diabetes, and 67% of them had sight-threatening DR (STDR). Diabetes duration (p = 0.007), poor glycemic control (HbA1c) (p = 0.006), higher systolic blood pressure (SBP) (p < 0.001), and diastolic blood pressure (DBP) (p = 0.002) were the main predictors of DR. However, the impact of SBP (AOR 1.07, p = 0.003) and DBP (AOR 1.13, p = 0.005) on DR development remained significant even after adjustment for diabetes duration and HbA1c. The DR prevalence was higher in patients with higher blood pressure (≥130/80 mmHg) than in those with target blood pressure (<130/80 mmHg) (p = 0.043). None of the patients with target blood pressure had STDR. The peaks in SBP and DBP were observed in T2DM with DR and the first fundus examination due to diabetes. Conclusions: In this T2DM sample, DR prevalence was very high and strongly related to blood pressure and a lack of regular fundus examinations. These results indicate the necessity of establishing systematic DR screening in routine diabetes care and targeting blood pressure levels according to T2DM guidelines.
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Affiliation(s)
- Martina Tomić
- Department of Ophthalmology, Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital, 10000 Zagreb, Croatia
| | - Romano Vrabec
- Department of Ophthalmology, Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital, 10000 Zagreb, Croatia
| | - Spomenka Ljubić
- Department of Diabetes and Endocrinology, Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital, 10000 Zagreb, Croatia
- School of Medicine, University of Zagreb, Šalata 3, 10000 Zagreb, Croatia
| | - Ingrid Prkačin
- School of Medicine, University of Zagreb, Šalata 3, 10000 Zagreb, Croatia
- Department of Internal Medicine, Merkur University Hospital, 10000 Zagreb, Croatia
| | - Tomislav Bulum
- Department of Diabetes and Endocrinology, Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital, 10000 Zagreb, Croatia
- School of Medicine, University of Zagreb, Šalata 3, 10000 Zagreb, Croatia
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Behrooznia Z, Jangjoo A, Qoorchi Moheb Seraj F, Khadem-Rezaiyan M, Zandbaf T, Hassani S. Diabetic Markers, Five Years after Bariatric Surgery. Middle East J Dig Dis 2023; 15:270-276. [PMID: 38523888 PMCID: PMC10955987 DOI: 10.34172/mejdd.2023.357] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2023] [Accepted: 09/18/2023] [Indexed: 03/26/2024] Open
Abstract
Background: Bariatric surgery delivers substantial weight loss for obese patients with comorbidities like diabetes mellitus. We aimed to investigate the impacts of bariatric surgery on diabetic markers after 5 years of follow-up. Methods: This is a retrospective study on patients with diabetes and a history of bariatric surgery between 2016-2017. The diabetic markers before and 5 years following surgery, including a lipid profile, glucose level, and the required antidiabetic medications, were evaluated. Results: 34 consecutive patients were included, 30 (88.2%) women, with a mean age of 52.71±8.53 years. The majority (65%) of surgeries were Roux-en-Y gastric bypass (RYGB), and the remaining were one anastomosis gastric bypass (OAGB) and sleeve gastrectomy (SG). The serum levels of diabetic markers reduced during follow-up (P=0.001), except for high-density lipoprotein levels and serum total cholesterol, which increased (P=0.011, P=0.838). Low-density lipoprotein levels reduced, but it was insignificant (P=0.194). Surgery types had affected the changes of diabetic markers (P>0.05). Demand for oral medication was reduced significantly, but insulin injection reduction was not significant (P=0.006 and P=0.099, respectively). Conclusion: Our study showed favorable bariatric surgery results on patients with diabetes in long-term follow-up. However, dyslipidemia is still a concern.
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Affiliation(s)
- Zahra Behrooznia
- Department of Internal Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Ali Jangjoo
- Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Farid Qoorchi Moheb Seraj
- Neurosurgical Department, NeuroVascular Section, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Majid Khadem-Rezaiyan
- Department of Community Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Tooraj Zandbaf
- Department of General surgery, School of medicine, Mashhad Azad university of medical sciences, Mashhad, Iran
| | - Solmaz Hassani
- Endocrine Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
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Diagnostic and Prognostic Value of Glycated Hemoglobin (HbA1c) in Patients with Diabetes Mellitus and Thalassemia. ACTA MEDICA BULGARICA 2020. [DOI: 10.2478/amb-2020-0027] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
Abstract
Abstract
Diabetes mellitus (DM) is a metabolic disease characterized by hyperglycemia, which is caused by impaired insulin secretion, insulin action, or both. Four complications of DM have been identified – diabetes microangiopathy including nephropathy, retinopathy and polyneuropathy and diabetes macroangiopathy. DM is diagnosed on the basis of one of the following criteria: 1. Presence of typical symptoms – polyuria, polyphagia, polydipsia, weight loss and accidental plasma glucose value ≥ 11.1 mmol/l. 2. Fasting plasma glucose level ≥ 7.0 mmol/l. 3. Oral Glucose Tolerance Test (OGTT) – 2-hour blood glucose level ⩾ 11.1 mmol/l. 4. Test for glycated hemoglobin HbA1c⩾6.5%. Regular monitoring of blood glucose is crucial for good control of diabetes. Two are the most commonly available methods for glycemic monitoring – 1) home self-assessment; 2) HbA1c test. In this paper we discuss the diagnostic and prognostic value of HbA1c in comorbid patients with DM and diseases, where there are deviations in hemoglobin and erythrocyte values. In the scientific literature, single reports are available that give scarce guidance on how to manage these patients. It is mentioned that anemia should be treated individually, however no data could be found on what should be the standard behavior in such patients. According to the American Diabetes Association, only the blood glucose should be used when the relationship between HbA1c and glycemia is altered. Because of the diverse gene pool of the US population, different variants of hemoglobin may interfere with HbA1c measurements, although tests in the USA are standardized. Discrepancies between HbA1c and plasma glucose should suggest that testing for HbA1c may not be reliable for a particular patient. We present a clinical case of a comorbid patient with DM and thalassemia minor, whose glycemic control with glycated hemoglobin HbA1c is unreliable.
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Lapena C, Borràs E, Digon C, Aznar R, Del Val Garcia JL, Castelblanco E, Garaikoetxea A, Laguna V. Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-experimental trial. BMJ Open 2020; 10:e033725. [PMID: 32580980 PMCID: PMC7312326 DOI: 10.1136/bmjopen-2019-033725] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/19/2019] [Revised: 04/22/2020] [Accepted: 05/01/2020] [Indexed: 11/26/2022] Open
Abstract
INTRODUCTION Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease in the Spanish population. Typically, T2DM is associated with other chronic conditions. Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications. However, it has not yet been demonstrated that a comprehensive and intensive health education protocol at the time of diagnosis has the benefits described previously. Currently, there is great variability in the practices of primary care nurses regarding health education at the time of disease diagnosis.We aimed to evaluate the effectiveness of a systematic protocol with a comprehensive care programme in people with newly diagnosed T2DM with associated comorbidities. METHODS AND ANALYSIS A multicentre quasi-experimental design comparing a group of individuals taking part in the intervention (intervention group (IG)) with a similar group receiving standard diabetes care (comparison group (CG)) is planned. The intervention will take place during the 3 months after study enrolment. Data will be collected at baseline and at 3, 6 and 12 months. Ten primary care centres in Barcelona city will be selected for participation: 5 for the IG and 5 for the CG. The IG will include five structured individual visits postdiagnosis with the primary care nurse, during which aspects of diabetes education will be discussed with the patient and his/her family. The results will be measured in terms of health-related quality of life and the change in main outcomes (glycated haemoglobin and weight). ETHICS AND DISSEMINATION The study fully met the requirements of the Ethical Committee of Clinical Investigation of the IDIAP Jordi Gol (approval code: P13/118). Patients will be informed that their data are confidential, and they have the right to withdraw at any time without penalty. Dissemination will include publishing the findings in peer-reviewed journals and sharing our findings at scientific conferences. TRIAL REGISTRATION NUMBER NCT03990857; Pre-results.
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Affiliation(s)
- Carolina Lapena
- Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain
- Unitat de Suport a la Recerca Barcelona Ciutat, Fundació Institut Universitari per a la recerca en Atenció Primària de Salut Jordi Gol i Gurina (IDIAP Jordi Gol), Barcelona, Spain
| | - Enriqueta Borràs
- Gerència Territorial de Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain
| | - Clarisa Digon
- Centre d'Atenció Primària Sagrera, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain
| | - Rosa Aznar
- Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain
| | - Jose Luis Del Val Garcia
- Unitat de Suport a la Recerca Barcelona Ciutat, Fundació Institut Universitari per a la recerca en Atenció Primària de Salut Jordi Gol i Gurina (IDIAP Jordi Gol), Barcelona, Spain
- Unidad de Evaluación, Sistemas de Información y Calidad, Institut Català de la Salut, Barcelona, Spain
| | - Esmeralda Castelblanco
- DAP-Cat Group, Unitat de Suport a la Recerca Barcelona, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain
- Department of Endocrinology and Nutrition, Hospital de la Santa Creu i Sant Pau & Institut d'Investigació Biomédica Sant Pau (IIB Sant Pau) & Centre for Biomedical Research on Diabetes and Associated Metabolic Diseases (CIBERDEM), Barcelona, Spain
| | - Ana Garaikoetxea
- Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain
| | - Vicencia Laguna
- Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain
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Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition in Obese Females with Type 2 Diabetes Mellitus: Results After 1-Year Follow-up. Obes Surg 2020; 29:805-810. [PMID: 30448981 DOI: 10.1007/s11695-018-3603-3] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
PURPOSE To present the early metabolic effects of sleeve gastrectomy with transit bipartition (SG + TB) procedure in female obese patients with type 2 diabetes mellitus (T2DM). METHODS This prospective clinical study was carried out between January 2016 and June 2017. Inclusion criteria were female participants under 60 years old with T2DM, body mass index ≥ 40 kg/m2 and HbA1c level ≥ 8%. All patients underwent to SG + TB procedure. Primary outcomes were the glycemic control variables, and the secondary outcomes were weight loss and dyslipidemia levels up to the last follow-up point. RESULTS A total of 35 female participants with an average age of 48.8 ± 6.0 years old and a mean preoperative BMI of 42.0 ± 1.3 kg/m2 were included during the study period. Diabetic remission was achieved in 88.6% of patients (n = 31) on the third month without any antidiabetic medications. The mean postoperative BMI of patients was 24.8 ± 1.6 kg/m2, and dyslipidemia levels were significiantly lower at the last follow-up point of all patients. CONCLUSIONS SG + TB procedure may be a potent therapeutic option for the treatment of obese patients with T2DM.
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Biliopancreatic Diversion Induces Greater Metabolic Improvement Than Roux-en-Y Gastric Bypass. Cell Metab 2019; 30:855-864.e3. [PMID: 31588013 PMCID: PMC6876863 DOI: 10.1016/j.cmet.2019.09.002] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/08/2019] [Revised: 07/03/2019] [Accepted: 09/03/2019] [Indexed: 12/12/2022]
Abstract
Diabetes remission is greater after biliopancreatic diversion (BPD) than Roux-en-Y gastric bypass (RYGB) surgery. We used a mixed-meal test with ingested and infused glucose tracers and the hyperinsulinemic-euglycemic clamp procedure with glucose tracer infusion to assess the effect of 20% weight loss induced by either RYGB or BPD on glucoregulation in people with obesity (ClinicalTrials.gov number: NCT03111953). The rate of appearance of ingested glucose into the circulation was much slower, and the postprandial increases in plasma glucose and insulin concentrations were markedly blunted after BPD compared to after RYGB. Insulin sensitivity, assessed as glucose disposal rate during insulin infusion, was ∼45% greater after BPD than RYGB, whereas β cell function was not different between groups. These results demonstrate that compared with matched-percentage weight loss induced by RYGB, BPD has unique beneficial effects on glycemic control, manifested by slower postprandial glucose absorption, blunted postprandial plasma glucose and insulin excursions, and greater improvement in insulin sensitivity.
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Early Results of Laparoscopic Sleeve Gastrectomy With Loop Bipartition. Surg Laparosc Endosc Percutan Tech 2019; 28:385-389. [PMID: 29782429 DOI: 10.1097/sle.0000000000000541] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Abstract
PURPOSE We evaluated early results of this new procedure of transit loop bipartition with sleeve gastrectomy (TLB-SG), making a comparison with transit bipartition with sleeve gastrectomy. MATERIALS AND METHODS Between January 2017 and September 2017, 22 patients have undergone transit bipartition with sleeve gastrectomy or TLB-SG surgery in our clinic. Patients' body mass index, excess body mass index loss, and HOMA-IR were calculated before and after the surgical operation. The values of c-peptide, HgA1C, insulin, blood sugar, albumin, Hg, urea, creatinine, calcium, total cholesterol, 25-hydroxy vitamin D, and vitamin B12 were evaluated retrospectively. RESULTS Vitamin and mineral deficiency, malnutrition, and anemia were not observed in both groups during the follow-up process. The operation time was shorter in the TLB-SG operation. Both groups were found to be effective at the expected level in terms of weight loss, diabetes remission, and improvement. CONCLUSIONS TLB-SG is a more effective and simpler method, becoming a candidate for being the most frequently performed surgical operation, in the field of metabolic surgery.
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Ren S, Zhang Y, Li B, Bu K, Wu L, Lu Y, Lu Y, Qiu Y. Downregulation of lncRNA-SRA participates in the development of cardiovascular disease in type II diabetic patients. Exp Ther Med 2019; 17:3367-3372. [PMID: 30988713 PMCID: PMC6447805 DOI: 10.3892/etm.2019.7362] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2018] [Accepted: 01/18/2019] [Indexed: 11/28/2022] Open
Abstract
Long non-coding RNA steroid receptor RNA activator (lncRNA-SRA) has been proven to regulate vascular smooth muscle cell (VSMC) proliferation, indicating its possible involvement in cardiovascular disease. Diabetes is a major cause of cardiovascular disease. The aim of the present study was to investigate the involvement of lncRNA-SRA in type II diabetic cardiovascular disease. The plasma levels of lncRNA-SRA were identified to be significantly lower in patients with type II diabetic cardiovascular disease compared with those in type II diabetic patients without any obvious complications and in healthy controls. A 5-year follow-up study revealed that low vs. high expression levels of lncRNA-SRA were associated with an increased incidence of cardiovascular disease in type II diabetic patients. High-glucose treatment did not significantly affect the expression of lncRNA-SRA in human VSMCs in vitro. However, ectopic overexpression of lncRNA-SRA increased the viability of human VSMCs in a high-glucose environment. It was concluded that downregulation of lncRNA-SRA may participate in the development of cardiovascular disease in type II diabetic patients.
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Affiliation(s)
- Shuang Ren
- Department of General Internal Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China
| | - Yi Zhang
- Department of Internal Medicine-Cardiovascular, Nanning Second People's Hospital, Nanning, Guangxi 530031, P.R. China
| | - Bixun Li
- Department of General Internal Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China
| | - Kunpeng Bu
- Department of General Internal Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China
| | - Lili Wu
- Department of General Internal Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China
| | - Yang Lu
- Department of General Internal Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China
| | - Yanyan Lu
- Department of General Internal Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China
| | - Ye Qiu
- Department of General Internal Medicine, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China
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Zhang Q, Hu XF, Xin MM, Liu HB, Sun LJ, Morris-Natschke SL, Chen Y, Lee KH. Antidiabetic potential of the ethyl acetate extract of Physalis alkekengi and chemical constituents identified by HPLC-ESI-QTOF-MS. JOURNAL OF ETHNOPHARMACOLOGY 2018; 225:202-210. [PMID: 29981847 DOI: 10.1016/j.jep.2018.07.007] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/23/2018] [Revised: 06/29/2018] [Accepted: 07/04/2018] [Indexed: 06/08/2023]
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE The edible plant Physalis alkekengi (PA) is used in traditional medicine to treat diabetes. However, the anti-diabetic effects and constituents of the fruit and aerial parts of this plant have not been studied extensively. AIM OF THE STUDY The purpose of this study was to investigate the antidiabetic potential of Physalis alkekengi and identify its chemical constituents. MATERIALS AND METHODS In the present study, the in vitro glucose uptake capacity was tested using the 2-[N-(7-nitrobenz-2-oxa-1,3-diazol-4-yl)amino]-2-deoxy-d-glucose (2-NBDG) assay in HepG2 cells. Secondly, the anti-diabetes effects of the ethyl acetate extracts of the aerial parts/fruit (EAP/EAF) of P. alkekengi were evaluated in high-fat diet-fed and streptozotocin-induced diabetic rats (seven groups, n = 7) daily at doses of 300 and 600 mg/kg for 28 days. Fasting blood glucose (FBG) was measured with a glucometer and the levels of total cholesterol (TC), triglyceride (TG), glycated serum protein (GSP), and fasting insulin (FINS) were measured by ELISA. Furthermore, insulin sensitivity index (ISI) and homeostasis model assessment-insulin resistance index (HOMA-IR) were calculated based on FBG and FINS. Changes in blood glucose concentration were assessed after an oral glucose challenge in diabetic rats treated with EAF and EAP extracts. In all assays, rosiglitazone, a current antidiabetic drug and insulin sensitizer, was also tested. Finally, the compounds in EAP were identified by HPLC-ESI-QTOF-MS analysis. RESULTS EAP increased the uptake of 2-NBDG, a measure of direct glucose uptake, in HepG2 cells. Next, in diabetic rats treated with P. alkegenki extracts for 28 days, the levels of FBG, TC, TG and GSP and were lowered effectively, while FINS was increased significantly. EAP/EAF enhanced insulin sensitivity significantly as measured by ISI and HOMA-IR along with oral glucose tolerance test analysis. The EAP generally exerted the greatest effects. Lastly, a HPLC-ESI-Q-TOF-MS analysis identified 50 compounds, including 26 physalins, 10 flavonoids, and 9 phenolic acids, with 21 compounds found for the first time in P. alkekengi. CONCLUSIONS The results support the merit of P. alkekengi as an antidiabetic herbal medicine or dietary supplement.
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Affiliation(s)
- Qiang Zhang
- National & Local Joint Engineering Research Center of High-throughput Drug Screening Technology, Hubei Province Key Laboratory of Biotechnology of Chinese Traditional Medicine, Hubei University, Wuhan 430062, PR China.
| | - Xiao-Fang Hu
- National & Local Joint Engineering Research Center of High-throughput Drug Screening Technology, Hubei Province Key Laboratory of Biotechnology of Chinese Traditional Medicine, Hubei University, Wuhan 430062, PR China.
| | - Man-Man Xin
- National & Local Joint Engineering Research Center of High-throughput Drug Screening Technology, Hubei Province Key Laboratory of Biotechnology of Chinese Traditional Medicine, Hubei University, Wuhan 430062, PR China.
| | - Hong-Bing Liu
- State Key Laboratory of Magnetic Resonance and Atomic and Molecular Physics, Wuhan 430062, PR China.
| | - Li-Juan Sun
- National & Local Joint Engineering Research Center of High-throughput Drug Screening Technology, Hubei Province Key Laboratory of Biotechnology of Chinese Traditional Medicine, Hubei University, Wuhan 430062, PR China.
| | - Susan L Morris-Natschke
- Natural Products Research Laboratories, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599-7568, USA.
| | - Yong Chen
- National & Local Joint Engineering Research Center of High-throughput Drug Screening Technology, Hubei Province Key Laboratory of Biotechnology of Chinese Traditional Medicine, Hubei University, Wuhan 430062, PR China.
| | - Kuo-Hsiung Lee
- Natural Products Research Laboratories, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599-7568, USA; Chinese Medicine Research and Development Center, China Medical University and Hospital, Taichung 40402, Taiwan.
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Božek T, Bilić-Ćurčić I, Berković MC, Gradišer M, Kurir TT, Majanović SK, Marušić S. The effectiveness of lixisenatide as an add on therapy to basal insulin in diabetic type 2 patients previously treated with different insulin regimes: a multi-center observational study. Diabetol Metab Syndr 2018; 10:16. [PMID: 29563974 PMCID: PMC5850977 DOI: 10.1186/s13098-018-0321-x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/19/2017] [Accepted: 03/08/2018] [Indexed: 01/10/2023] Open
Abstract
INTRODUCTION This observational study aimed to assess the effectiveness of lixisenatide as add on therapy to basal insulin in diabetic type 2 patients previously treated with different insulin regimes. METHODS Patients with diabetes type 2, prescribed with lixisenatide and basal insulin were divided in three groups (premixed insulin, basal bolus insulin and basal oral therapy (BOT). Difference in mean change in HbA1c, body mass index, total insulin doses, fasting blood glucose (FPG) and prandial blood glucose (PPG) were assessed after 3-6-months of follow-up. RESULTS The primary outcomes were assessed in 111 patients. Lixisenatide added to basal insulin, reduced HbA1c and body weight significantly in all three groups of patients (p < 0.001 for all), with the most prominent reduction in the basal bolus group of patients which had the highest baseline HbA1c compared to premix and BOT treatment groups. Regarding a difference in total insulin dose the reduction was statistically significant in the basal bolus (p = 0.006) and premix group (p < 0.001). FPG and PPG were also significantly reduced over time in all three groups (p < 0.001 for all). A composite outcome (reduction of HbA1c below 7% (53 mmol/mol) with any weight loss) was achieved in 27% of total patients included in the study, reduction of HbA1c below 7% was observed in 30% of patients, while 90% of patients experienced weight reduction. CONCLUSION These results indicate that lixisenatide add on basal insulin treatment (BIT) can improve glycemic control in a population with long-standing type 2 diabetes and previously uncontrolled on other insulin therapy.
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Affiliation(s)
- Tomislav Božek
- University Clinic for Diabetes Vuk Vrhovac, Zagreb, Croatia
| | - Ines Bilić-Ćurčić
- Department of Pharmacology, Faculty of Medicine, University J. J. Strossmayer Osijek, Clinical Hospital Center, Osijek, J. Huttlera 4, 31000 Osijek, Croatia
| | - Maja Cigrovski Berković
- Department for Endocrinology, Diabetes and Metabolism, University Hospital Centre “Sestre Milosrdnice”, Zagreb, Croatia
| | - Marina Gradišer
- Internal Medicine Ward, General Hospital Čakovec, Čakovec, Croatia
| | - Tina Tićinović Kurir
- Department for Endocrinology, Diabetes and Metabolism, University Hospital Center Split, Split, Croatia
| | - Sanja Klobučar Majanović
- Department for Endocrinology, Diabetes and Metabolism, University Hospital Center Rijeka, Rijeka, Croatia
| | - Srećko Marušić
- Department for Endocrinology, Diabetes and Metabolism, Clinical Hospital Dubrava, Zagreb, Croatia
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Bozek T, Blazekovic A, Perkovic MN, Jercic KG, Sustar A, Smircic-Duvnjak L, Outeiro TF, Pivac N, Borovecki F. The influence of dopamine-beta-hydroxylase and catechol O-methyltransferase gene polymorphism on the efficacy of insulin detemir therapy in patients with type 2 diabetes mellitus. Diabetol Metab Syndr 2017; 9:97. [PMID: 29225702 PMCID: PMC5716004 DOI: 10.1186/s13098-017-0295-0] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2017] [Accepted: 11/22/2017] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND Type II diabetes is an important health problem with a complex connection to obesity, leading to a broad range of cardiovascular complications. Insulin therapy often results in weight gain and does not always ensure adequate glycemic control. However, previous studies reported that insulin detemir is an efficient long-acting insulin with a weight sparing effect. The aim of this study was to determine the association of catechol O-methyltransferase (COMT) Val108/158Met and dopamine-beta-hydroxylase (DBH) 1021C/T polymorphisms with the effectiveness of insulin detemir in achieving glucose control and body weight control. Participants and methods: This 52-week observational study included 185 patients with inadequate glycemic control treated with premix insulin analogues, which were replaced with insulin aspart and insulin detemir, and 156 healthy controls. After DNA isolation from blood samples, genotyping of DBH-1021C/T polymorphism (rs1611115) and COMT Val108/158Met polymorphism (rs4680) was performed. RESULTS Our results confirmed that insulin detemir did not lead to weight gain. The most significant finding was that A carriers (the combined AG and AA genotype) of the COMT Val108/158Met achieved significantly better hemoglobin A1c (HbA1c) values compared to patients carrying GG genotype. No association between DBH-1021C/T genotypes and weight and/or glucose control was detected in diabetes patients or in healthy control subjects. CONCLUSIONS This study showed that the presence of one or two A allele of the COMT Val108/158Met was associated with improved glycemic response, and with a better response to insulin detemir therapy in patients with type II diabetes, separating them as best candidates for detemir therapy.
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Affiliation(s)
- Tomislav Bozek
- Vuk Vrhovac University Clinic, Merkur University Hospital, Zagreb, Croatia
| | - Antonela Blazekovic
- Department for Functional Genomics, Center for Translational and Clinical Research, University of Zagreb School of Medicine, University Hospital Center Zagreb, Šalata 2, Zagreb, Croatia
| | | | - Kristina Gotovac Jercic
- Department for Functional Genomics, Center for Translational and Clinical Research, University of Zagreb School of Medicine, University Hospital Center Zagreb, Šalata 2, Zagreb, Croatia
| | - Aleksandra Sustar
- Department of Cardiology, University Hospital Center Rijeka, Rijeka, Croatia
| | | | - Tiago F. Outeiro
- Department of Experimental Neurodegeneration, Center for Nanoscale Microscopy and Molecular Physiology of the Brain (CNMPB), Center for Biostructural Imaging of Neurodegeneration, University Medical Center Göttingen, Göttingen, Germany
- Max Planck Institute for Experimental Medicine, Göttingen, Germany
| | - Nela Pivac
- Division of Molecular Medicine, Rudjer Boskovic Institute, Zagreb, Croatia
| | - Fran Borovecki
- Department for Functional Genomics, Center for Translational and Clinical Research, University of Zagreb School of Medicine, University Hospital Center Zagreb, Šalata 2, Zagreb, Croatia
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García Díaz E, Ramírez Medina D, García López A, Morera Porras ÓM. Determinants of adherence to hypoglycemic agents and medical visits in patients with type 2 diabetes mellitus. ENDOCRINOLOGÍA, DIABETES Y NUTRICIÓN (ENGLISH ED.) 2017. [DOI: 10.1016/j.endien.2017.08.015] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
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García Díaz E, Ramírez Medina D, García López A, Morera Porras ÓM. Determinants of adherence to hypoglycemic agents and medical visits in patients with type 2 diabetes mellitus. ACTA ACUST UNITED AC 2017; 64:531-538. [PMID: 29108925 DOI: 10.1016/j.endinu.2017.08.004] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2017] [Revised: 07/27/2017] [Accepted: 08/21/2017] [Indexed: 11/17/2022]
Abstract
AIM To assess glycemic control in diabetic patients, to measure the impact on such control of adherence to hypoglycemic agents and to medical visits, and to explore factors that allow for predicting adherence. METHODS Study of historical cohorts of diabetic patients. The proportion of patients who achieved the target HbA1c levels was estimated. Adherence was assessed using the Haynes-Sackett test. Change in HbA1c from the first to the last visit, adherence, and attendance to visits were analyzed according to comorbidities, cardiovascular risk factors, and treatments used. RESULTS The study simple consisted of 639 patients (mean follow-up time, 11.1±11.2 months), of whom 66.6% achieved target HbA1c levels. Change in HbA1c from the first to the last visit was explained in 54.2% of patients by baseline HbA1c (P<0.001), in 13% by treatment adherence (P<0.001), and in 9.6% by visit adherence (P<0.001). Non-insulinization (P=0.011) and smoking cessation (P=0.032) predisposed to greater adherence. Insulinization (P=0.019) and lack of diabetes education (P=0.033) predisposed to visit non-compliance. CONCLUSIONS Improvement in HbA1c is determined by baseline HbA1c, treatment adherence, and attendance to visits. Patients on insulin have poorer adherence and are more likely to miss the appointments, those who stop smoking adhere more to hypoglycemic agents, and those given therapeutic education are more likely to keep the appointments.
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Affiliation(s)
- Eduardo García Díaz
- Unidad de Endocrinología, Hospital Dr. José Molina Orosa, Lanzarote, Canarias, España.
| | | | - Alba García López
- Unidad de Oftalmología, Hospital Dr. José Molina Orosa, Lanzarote, Canarias, España
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Elkhidir AE, Eltaher HB, Mohamed AO. Association of lipocalin-2 level, glycemic status and obesity in type 2 diabetes mellitus. BMC Res Notes 2017; 10:285. [PMID: 28709459 PMCID: PMC5513122 DOI: 10.1186/s13104-017-2604-y] [Citation(s) in RCA: 34] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2016] [Accepted: 07/07/2017] [Indexed: 01/06/2023] Open
Abstract
BACKGROUND Management of type 2 diabetes mellitus aims to maintain a normal glycemic status, which if not, it may lead to acute and/or chronic diabetic complications. Earlier studies found Lipocalin-2 elevated in complications associated with type 2 diabetes mellitus such as ischemic heart disease. These lipocalin-2 changes had been linked to obesity and uncontrolled diabetes. So, it could be useful to understand the effect of glycemic control and obesity on lipocalin-2. METHODS This was a case control study. Fifty-seven patients with type 2 diabetes and 30 non-diabetic controls participated after getting a written consent. Weight (kg), height (m) and waist circumference (cm) were measured then the body mass index (kg/m2) was determined. Blood samples were collected after an overnight fasting. HbA1c, lipid profile and serum creatinine were measured using enzymatic methods. Lipocalin-2 was measured using sandwich ELISA. RESULTS Lipocalin-2 was found significantly higher in patients with type 2 diabetes (P = 0.001). However, it had no significant correlation with any of the studied variables. Females had elevated BMI compared to males in the patients group (P < 0.001). HbA1c, serum creatinine, LDL and total cholesterol were elevated in patients with diabetes (P < 0.02). HDL was lower in the patients (P = 0.002). Significant elevation in HbA1c was found in male patients (P = 0.028) compared to female patients. Patients were further classified into controlled, uncontrolled diabetics, obese and non-obese. There was a significant elevation in waist circumference in uncontrolled diabetics compared to controlled ones. Lipocalin-2 had no significant changes between controlled and uncontrolled diabetics nor non-obese and obese patients. CONCLUSION Patients with type 2 diabetes mellitus have elevated level of serum lipocalin-2. There was no significant association found between lipocalin-2 and glycemic control nor obesity.
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Affiliation(s)
- Areej E. Elkhidir
- Department of Biochemistry, Faculty of Medicine, University of Khartoum, P O Box 102, Khartoum, Sudan
| | - Halima B. Eltaher
- Department of Biochemistry, Faculty of Medicine, University of Khartoum, P O Box 102, Khartoum, Sudan
- Department of Biochemistry, School of Medicine, Ahfad University of Women, Omdurman, Sudan
| | - Abdelrahim O. Mohamed
- Department of Biochemistry, Faculty of Medicine, University of Khartoum, P O Box 102, Khartoum, Sudan
- Al-Neelain Institute for Medical Research, Al-Neelain University, Khartoum, Sudan
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16
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Govender RD, Gathiram P, Panajatovic M. Poor control and management of type 2 diabetes mellitus at an under-resourced South African Hospital: is it a case of clinical inertia? S Afr Fam Pract (2004) 2017. [DOI: 10.1080/20786190.2017.1307909] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022] Open
Affiliation(s)
- Romona Devi Govender
- Department of Family Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa
| | - Prem Gathiram
- Department of Family Medicine, College of Health Sciences, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa
| | - Miljenko Panajatovic
- Department of Family Medicine, Port Shepstone Regional Hospital, Port Shepstone, South Africa
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Müller N, Khunti K, Kuss O, Lindblad U, Nolan JJ, Rutten GE, Trento M, Porta M, Roth J, Charpentier G, Jörgens V, Müller UA. Is there evidence of potential overtreatment of glycaemia in elderly people with type 2 diabetes? Data from the GUIDANCE study. Acta Diabetol 2017; 54:209-214. [PMID: 27837286 DOI: 10.1007/s00592-016-0939-9] [Citation(s) in RCA: 35] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2016] [Accepted: 11/01/2016] [Indexed: 02/05/2023]
Abstract
AIMS We used data from the GUIDANCE Study to determine the care of people with type 2 diabetes according to age and accompanying cardiovascular diseases and to assess indicators of overtreatment of glycaemia. METHODS The GUIDANCE study was a retrospective, cross-sectional study from 2009-2010 based on the records of 7597 people in France, Belgium, Italy, the Netherlands, Sweden, UK, Ireland and Germany. We analysed the level of metabolic control achieved and blood glucose-lowering medication used in different age groups and in relation to accompanying diseases. RESULTS 4.459 patients (59.1%) were 65 years or older. Their HbA1c levels were similar to those with <65 years. 44.7% of patients ≥65 years had an HbA1c ≤7% (53 mmol/mol) and were treated with insulin or sulfonylureas, and 27.1% of them had ischaemic heart disease or congestive heart failure. Significantly more patients with heart disease had HbA1c values ≤7% (53 mmol/mol) and were treated more often with insulin or sulfonylureas compared to patients of the same age without heart disease. CONCLUSIONS Most patients were treated according to guidelines valid at the time this large international patient sample was surveyed. Older and younger patients were at a similar level of metabolic control, and almost half of the patients with an age of ≥65 years and treated with insulin or sulfonylurea had HbA1c levels below the target range (≤7%) for younger patients. However, these patients have an increased risk of severe hypoglycaemic events with potentially dangerous complications, particularly in those with cardiovascular diseases.
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Affiliation(s)
- Nicolle Müller
- Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine III, Jena University Hospital, Bachstr. 18, 07743, Jena, Germany.
| | - Kamlesh Khunti
- Department of Health Sciences, University of Leicester, Leicester, UK
| | - Oliver Kuss
- Institute for Biometrics and Epidemiology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich Heine University, Düsseldorf, Germany
- German Center for Diabetes Research (DZD), 85764, München-Neuherberg, Germany
| | - Ulf Lindblad
- Department of Community Medicine/Primary Health Care, University of Gothenburg, Gothenburg, Sweden
| | | | - Guy Ehm Rutten
- Department of General Practice, Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands
| | - Marina Trento
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Massimo Porta
- Department of Medical Sciences, University of Turin, Turin, Italy
| | - Johannes Roth
- Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine III, Jena University Hospital, Bachstr. 18, 07743, Jena, Germany
| | | | | | - Ulrich A Müller
- Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine III, Jena University Hospital, Bachstr. 18, 07743, Jena, Germany
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18
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Mata-Cases M, Mauricio D, Franch-Nadal J. Clinical characteristics of type 2 diabetic patients on basal insulin therapy with adequate fasting glucose control who do not achieve HbA1c targets. J Diabetes 2017; 9:34-44. [PMID: 26749415 DOI: 10.1111/1753-0407.12373] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/01/2015] [Revised: 12/17/2015] [Accepted: 12/22/2015] [Indexed: 12/23/2022] Open
Abstract
BACKGROUND The aim of the present study was to determine the clinical characteristics of patients with type 2 diabetes mellitus (T2DM) treated with basal insulin who achieved an adequate fasting plasma glucose (FPG) level (<130 mg/dL), but were unable to achieve the HbA1c target (<7%; <53 mmol/mol). METHODS A cross-sectional study was performed on T2DM patients aged 31-90 years treated with basal insulin registered in the SIDIAPQ primary healthcare electronic database during 2010. RESULTS In 2010, of a population of 126 811 T2DM subjects, 9899 were treated with basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine). Of these, 23.5% (n = 2322) achieved optimal FPG control levels (<130 mg/dL) but an inadequate HbA1c target (>7%). Mean HbA1c values in the contolled and uncontrolled groups were 8.15% (65.6 mmol/mol) and 6.31% (45.5 mmol/mol), respectively. Patients with controlled FPG but uncontrolled HbA1c had longer T2DM duration (11.6 vs 9.9 years), higher systolic blood pressure (138.2 vs 136.3 mmHg) and low-density lipoprotein cholesterol (104 vs 99 mg /dL), and a higher prevalence of retinopathy (24.8% vs 18.2%) than patients (17.8%) with optimal control of both glycemic targets (P < 0.05). Multivariate analysis showed that inadequate glycemic control was positively related only to younger age. CONCLUSION One-quarter of T2DM patients treated with basal insulin have difficulties attaining the recommended HbA1c goal despite adequate FPG levels. As some guidelines state, healthcare professionals should focus on PPG to identify and intensify treatment to control prandial glucose excursions in these patients.
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Affiliation(s)
- Manel Mata-Cases
- Jordi Gol Institute for Research in Primary Care (Institut Universitari d'Investigació en Atenció Primària Jordi Gol), Barcelona, Spain
- Primary Health Care Centre La Mina, Barcelona, Spain
- Biomedical Research Network in Diabetes and Associated Metabolic Disorders (Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas -CIBERDEM-). Instituto de Salud Carlos III, Madrid, Spain
| | - Dídac Mauricio
- Jordi Gol Institute for Research in Primary Care (Institut Universitari d'Investigació en Atenció Primària Jordi Gol), Barcelona, Spain
- Department of Endocrinology and Nutrition, Hospital Germans Trias i Pujol, Badalona, Spain
- Biomedical Research Network in Diabetes and Associated Metabolic Disorders (Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas -CIBERDEM-). Instituto de Salud Carlos III, Madrid, Spain
| | - Josep Franch-Nadal
- Jordi Gol Institute for Research in Primary Care (Institut Universitari d'Investigació en Atenció Primària Jordi Gol), Barcelona, Spain
- Primary Health Care Centre Raval Sud, Institut Català de la Salut, Barcelona, Spain
- Biomedical Research Network in Diabetes and Associated Metabolic Disorders (Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas -CIBERDEM-). Instituto de Salud Carlos III, Madrid, Spain
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Bailey CJ. Under-treatment of type 2 diabetes: Causes and outcomes of clinical inertia. Int J Clin Pract 2016; 70:988-995. [PMID: 28032429 DOI: 10.1111/ijcp.12906] [Citation(s) in RCA: 29] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/10/2016] [Accepted: 10/02/2016] [Indexed: 12/16/2022] Open
Abstract
AIMS To assess the impact of clinical inertia on type 2 diabetes (T2D) care. METHODS PubMed database search from January 2000 until December 2015. RESULTS Clinical inertia, defined as resistance to initiate or intensify treatment in a patient not at the evidence-based glycated haemoglobin goal, is conservatively estimated to occur in at least 25% of patients with T2D. Consequently, many patients with diagnosed and treated T2D experience extended periods, in some cases years, of ineffectively controlled hyperglycaemia, potentially causing serious microvascular and macrovascular harm. Delayed treatment does not appear to be specific to primary care, but also occurs in the specialist setting. The causes of clinical inertia appear to be complex, involving both reasonable and unacceptable delays on the part of the clinician and poor compliance with treatment regimens on the part of the patient. Evidence suggests that the clinical and organisational context may be particularly important in reinforcing clinical inertia, notably the increasingly severe time constraints for diagnosis and management of multiple morbidities, consideration of complex guidelines, assessment of cost and appreciation of patient concerns, all of which may hamper prioritisation of the important issue of under-treatment. CONCLUSIONS Since the pharmacotherapeutic tools for good control of blood glucose exist in all advanced healthcare systems, initiatives to address the important and widespread problem of clinical inertia may require focused campaigns that encourage attention to guideline recommendations and their adaptation for individualised care.
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Affiliation(s)
- Clifford J Bailey
- Diabetes Research, Life and Health Sciences, Aston University, Birmingham, UK
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Lattanzi S, Bartolini M, Provinciali L, Silvestrini M. Glycosylated Hemoglobin and Functional Outcome after Acute Ischemic Stroke. J Stroke Cerebrovasc Dis 2016; 25:1786-1791. [DOI: 10.1016/j.jstrokecerebrovasdis.2016.03.018] [Citation(s) in RCA: 57] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2015] [Revised: 01/24/2016] [Accepted: 03/12/2016] [Indexed: 01/03/2023] Open
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Zhao P, Wang H, Li T, Lei C, Xu X, Wang W, Liang X, Ma C, Gao L. Increased T cell immunoglobulin and mucin domain containing 4 (TIM-4) is negatively correlated with serum concentrations of interleukin-1β in type 2 diabetes. J Diabetes 2016; 8:199-205. [PMID: 25676395 DOI: 10.1111/1753-0407.12276] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2014] [Revised: 12/21/2014] [Accepted: 01/20/2015] [Indexed: 12/17/2022] Open
Abstract
BACKGROUND T cell immunoglobulin and mucin domain containing 4 (TIM-4), a novel immune regulator, is selectively expressed on antigen-presenting cells, especially macrophages and mature dendritic cells. Although TIM-4 plays key roles in mutiple immune diseases, whether it is involved in type 2 diabetes mellitus (T2D) remains unknown. The aim of the present study was to investigate the expression of TIM-4 in T2D and determine its significance in disease progression. METHODS Peripheral blood mononuclear cells (PBMC) were isolated from T2D patients and healthy controls to measure TIM-4 mRNA expression by real-time polymerase chain reaction (PCR), and sera were collected to determine interleukin (IL)-1β concentrations and other clinical indicators (high-sensitivity C-reactive protein [hsCRP], total cholesterol, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol, triglyceride, fasting glucose, HbA1c, aspartate aminotransferase, and alanine aminotransferase). RESULTS Expression of TIM-4 mRNA was increased significantly in PBMCs from T2D patients compared with healthy controls. There was a positive correlation between TIM-4 mRNA expression and serum concentrations of hsCRP. However, there was a negative correlation between TIM-4 mRNA expression and IL-1β concentrations, indicating the potential role for TIM-4 to negatively regulate IL-1β production. In addition, TIM-4 mRNA expression was negatively correlated with lowLDL-C, and there was a tendency for a negative relationship between TIM-4 mRNA expression and HbA1c. CONCLUSIONS The results of the present study indicate that TIM-4 contributes, at least in part, to the pathogenesis of T2D, possibly by regulating IL-1β.
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Affiliation(s)
- Peiqing Zhao
- Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection & Immunology, Shandong University School of Medicine, Jinan, China
- Department of Central Laboratory, Zibo Central Hospital, Zibo, China
| | - Hongxing Wang
- Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection & Immunology, Shandong University School of Medicine, Jinan, China
| | - Tao Li
- Department of Central Laboratory, Zibo Central Hospital, Zibo, China
| | - Chengbin Lei
- Department of Central Laboratory, Zibo Central Hospital, Zibo, China
| | - Xiaoyan Xu
- Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection & Immunology, Shandong University School of Medicine, Jinan, China
| | - Wei Wang
- Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection & Immunology, Shandong University School of Medicine, Jinan, China
| | - Xiaohong Liang
- Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection & Immunology, Shandong University School of Medicine, Jinan, China
| | - Chunhong Ma
- Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection & Immunology, Shandong University School of Medicine, Jinan, China
| | - Lifen Gao
- Department of Immunology, Key Laboratory for Experimental Teratology of Ministry of Education, Shandong Provincial Key Laboratory of Infection & Immunology, Shandong University School of Medicine, Jinan, China
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Tiktin M, Celik S, Berard L. Understanding adherence to medications in type 2 diabetes care and clinical trials to overcome barriers: a narrative review. Curr Med Res Opin 2016; 32:277-87. [PMID: 26565758 DOI: 10.1185/03007995.2015.1119677] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
AIM To identify factors affecting adherence to medications in type 2 diabetes (T2D) care and clinical trials. BACKGROUND Adherence to medication is associated with better patient outcomes, lower healthcare costs, and improved quality and robustness of trial data. In T2D, non-adherence to regimens may compromise glycemic, blood pressure and lipid control, which can, in turn, increase morbidity and mortality rates. DESIGN A literature search was performed to identify studies reporting adherence to medications and highlighting specific adherence challenges/approaches in T2D. The search was limited to clinical trials, comparative studies or meta-analyses, reported in English with a freely available abstract. DATA SOURCE MEDLINE (31 December 2008 to 31 December 2013). REVIEW METHODS Studies not reporting adherence to medications or highlighting adherence challenges/approaches in T2D, presenting only self-reported adherence or including fewer than 100 patients were excluded. Eligible reports are discussed narratively. RESULTS Factors identified as having a detrimental impact on adherence were smoking, depression and polypharmacy. Conversely, increased convenience (e.g. pen compared with vial and syringe; medication supplied by mail order vs. retail pharmacy) was associated with better patient adherence, as were interventions that increased patient motivation (e.g. individualized, nurse-led consultation) and education. CONCLUSIONS Medication adherence is influenced by complex and multifactorial issues, which can include smoking, depression, polypharmacy, convenience of obtaining and administering the medication, patient motivation and education. We recommend simplifying treatment regimens, where possible, improving provider-patient communication, and providing support and education to increase medication adherence, with a view to improving patient outcomes and clinical trial data quality.
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Affiliation(s)
- Margaret Tiktin
- a a Endocrinology, Case Western Reserve University , Cleveland , Ohio , USA
| | - Selda Celik
- b b Istanbul Faculty of Medicine, Division of Endocrinology and Metabolism, Istanbul University , Istanbul , Turkey
| | - Lori Berard
- c c Winnipeg Regional Health Authority Health Sciences Centre , University of Manitoba , Winnipeg , Canada
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Marcellusi A, Viti R, Sciattella P, Aimaretti G, De Cosmo S, Provenzano V, Tonolo G, Mennini FS. Economic aspects in the management of diabetes in Italy. BMJ Open Diabetes Res Care 2016; 4:e000197. [PMID: 27843551 PMCID: PMC5073526 DOI: 10.1136/bmjdrc-2016-000197] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2016] [Revised: 07/29/2016] [Accepted: 08/15/2016] [Indexed: 12/26/2022] Open
Abstract
BACKGROUND Diabetes mellitus (DM) is a chronic-degenerative disease associated with a high risk of chronic complications and comorbidities. The aim of this study is to estimate the average annual cost incurred by the Italian National Health Service (NHS) for the treatment of DM stratified by patients' comorbidities. Moreover, the model estimates the economic impact of implementing good clinical practice for the management of patients with DM. METHODS Data were extrapolated from administrative database of the Marche Region and specific inclusion and exclusion criteria were developed from a clinical board in order to estimate patients with DM only, DM+1, DM+2, DM+3 and DM+4 comorbidities (cardiovascular disease, neuropathy, nephropathy and retinopathy). Regional data were considered a good proxy for implementing a previously developed cost-of-illness (COI) model from Italian NHS perspective already published. A scenario analysis was considered to estimate the economic impact of good clinical practice implementation in the treatment of DM and its comorbidities in Italy. RESULTS The model estimated an average number of patients with DM per year in the Marche region of 85.909 (5.5% of population) from 2008 to 2011. The mean costs per patients with DM only, DM+1, DM+2, DM+3 and DM+4 comorbidities were €341, €1,335, €2,287, €5,231 and €7,085 respectively. From the Italian NHS perspective, the total economic burden of DM in Italy amounted to €8.1. billion/year (22% for drugs, 74% for hospitalization and 4% for visits). Scenario analysis demonstrates that the implementation of good clinical practice could save over €700 million per year. CONCLUSIONS This model is the first study that considers real world data and COI model to estimate the economic burden of DM and its comorbidities from the Italian NHS perspective. Integrated management of the patients with DM could be a good driver for the reduction of the costs of this disease in Italy.
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Affiliation(s)
- A Marcellusi
- Economic Evaluation and HTA (EEHTA), CEIS, Faculty of Economics, University of Rome, Tor Vergata, Italy; National Research Council (CNR) - Institute for Research on Population and Social Policies (IRPPS), Rome, Italy
| | - R Viti
- Economic Evaluation and HTA (EEHTA), CEIS , Faculty of Economics, University of Rome , Tor Vergata , Italy
| | - P Sciattella
- Economic Evaluation and HTA (EEHTA), CEIS , Faculty of Economics, University of Rome , Tor Vergata , Italy
| | - G Aimaretti
- Department of Translational Medicine , University of the Eastern Piedmont , Novara, Italy
| | - S De Cosmo
- Complex Operative Unit of Internal Medicine IRCCS-CSS San Giovanni Rotondo (FG) , Italy
| | - V Provenzano
- Complex Operative Unit of Diabetology, Partinico Hospital, Partinico (PA) , Italy
| | - G Tonolo
- Diabetology Center, Local Health Unit 2 Olbia-Tempio , Olbia , Italy
| | - F S Mennini
- Economic Evaluation and HTA (EEHTA), CEIS, Faculty of Economics, University of Rome, Tor Vergata, Italy; Institute for Leadership and Management in Health - KingstonUniversity London, London, UK
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Bardini G, Innocenti M, Rotella CM, Giannini S, Mannucci E. Variability of triglyceride levels and incidence of microalbuminuria in type 2 diabetes. J Clin Lipidol 2015; 10:109-15. [PMID: 26892127 DOI: 10.1016/j.jacl.2015.10.001] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2015] [Revised: 07/06/2015] [Accepted: 10/02/2015] [Indexed: 10/22/2022]
Abstract
BACKGROUND Experimental and clinical studies have shown a strong association between hypertriglyceridemia and diabetic nephropathy. A variability of triglyceride (TG) levels has been reported in diabetes. OBJECTIVES To investigate the relationship of TG variability with the incidence of microalbuminuria (albumin excretion rate > 20 μg/min), in patients with type 2 diabetes. METHODS A longitudinal, retrospective, observational study was performed on a consecutive series of 457 normoalbuminuric outpatients, with measurements of HbA1c, lipids and microalbuminuria thrice per year with 6.8-year follow-up. TG variability, defined as standard deviation of TG (TG-SD) and TG-SD adjusted for the number of visits was calculated. A nested case-control sensitivity analysis was performed to validate the results of the primary cohort study. RESULTS Incident microalbuminuria (N = 124, 27.1%) was associated with higher median TG-SD (33.6 mg/dL vs 29.0 mg/dL, P < .05) and TG-SD adjusted for the number of visits (31.4 mg/dL vs 26.7 mg/dL, P < .05). At multivariate (Cox) analysis, logTG-SD and adj-logTG-SD were significant predictors of incident microalbuminuria (hazard ratio 2.1 [1.1-4.2], P = .028 and 1.5 [1.1-3.3], P = .042, respectively). In the case-control analysis, time spent with TG > 150 mg/dL during the follow-up was significantly higher in cases vs controls (27.2 ± 19 vs 16.7 ± 12.5 months, P < .05) with hazard ratio 2.0 (1.1-5.1), P < .05, for adj-logTG-SD. CONCLUSIONS A higher intraindividual TG variability is a predictor of incident microalbuminuria in type 2 diabetes. In addition, time of exposure to elevated TG levels (>150 mg/dL) predicts incident microalbuminuria.
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Affiliation(s)
- Gianluca Bardini
- Department of Biomedical Clinical and Experimental Sciences, Obesity Agency, University of Florence and Careggi University Hospital, Florence, Italy
| | - Maddalena Innocenti
- Department of Biomedical Clinical and Experimental Sciences, Obesity Agency, University of Florence and Careggi University Hospital, Florence, Italy
| | - Carlo Maria Rotella
- Department of Biomedical Clinical and Experimental Sciences, Obesity Agency, University of Florence and Careggi University Hospital, Florence, Italy
| | - Stefano Giannini
- Section of Endocrinology, Department of Biomedical, Clinical and Experimental Sciences, University of Florence, Florence, Italy.
| | - Edoardo Mannucci
- Department of Geriatric Medicine, Diabetes Agency, Careggi University Hospital, Florence, Italy
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26
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Ruohonen ST, Ranta-Panula V, Bastman S, Chrusciel P, Scheinin M, Streng T. Potentiation of Glibenclamide Hypoglycaemia in Mice by MK-467, a Peripherally Acting Alpha2-Adrenoceptor Antagonist. Basic Clin Pharmacol Toxicol 2015; 117:392-8. [PMID: 26132275 DOI: 10.1111/bcpt.12440] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/21/2015] [Accepted: 06/25/2015] [Indexed: 12/17/2022]
Abstract
Pharmacological antagonism and genetic depletion of pancreatic α2A-adrenoceptors increase insulin secretion in mice and enhance the insulinotropic action of glibenclamide, a representative of the sulphonylurea class of insulin secretagogues used in the therapy of type 2 diabetes. Antagonism of α2-adrenoceptors in the central nervous system (CNS) causes tachycardia and hypertension, making generalized α2-adrenoceptor blockade unfavourable for clinical use despite its potential to decrease blood glucose levels. The purpose of this study was to test the acute effects of the peripherally acting α2-adrenoceptor antagonist MK-467 alone and in combination with glibenclamide in non-diabetic C57BL/6N mice. Cardiovascular safety was assessed in freely moving mice with radiotelemetry. Dose-dependent decreases in blood glucose and increases in plasma insulin concentrations were seen with the combination of MK-467 and glibenclamide; the combinations were much more potent than glibenclamide or MK-467 alone. Furthermore, MK-467 had no effect on mean arterial pressure or heart rate in freely moving mice and did not prevent the centrally mediated hypotensive effect of the α2-adrenoceptor agonist medetomidine. Thus, peripheral blockade of α2-adrenoceptors does not evoke the same cardiovascular adverse effects as antagonism of CNS α2-adrenoceptors. The current results indicate that the combined use of small doses of a peripherally acting α2-adrenoceptor antagonist with a sulphonylurea drug could provide a novel option for the treatment of type 2 diabetes, especially in patients with increased tonic α2-adrenoceptor-mediated inhibition of insulin secretion.
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Affiliation(s)
- Suvi T Ruohonen
- Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland.,Turku Center for Disease Modeling, University of Turku, Turku, Finland
| | - Ville Ranta-Panula
- Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland
| | - Sanna Bastman
- Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland
| | - Paulina Chrusciel
- Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland.,Turku Center for Disease Modeling, University of Turku, Turku, Finland
| | - Mika Scheinin
- Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland.,Unit of Clinical Pharmacology, Turku University Hospital, Turku, Finland
| | - Tomi Streng
- Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland.,Turku Center for Disease Modeling, University of Turku, Turku, Finland.,Department of Biology, Laboratory of Animal Physiology, University of Turku, Turku, Finland
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Røder ME. PEGylated insulin Lispro (LY2605541): clinical overview of a new long-acting basal insulin analog in the treatment of Type 2 diabetes mellitus. Expert Rev Endocrinol Metab 2015; 10:365-374. [PMID: 30293492 DOI: 10.1586/17446651.2015.1043270] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Neutral Protamine Hagedorn insulin with an intermediate action profile has been in use for many years for the treatment of Type 1 diabetes and as an option for Type 2 diabetes. It is efficacious in reducing blood sugars, but shows substantial variability and risk of hypoglycemia. Basal insulin analogs have been developed in recent years to overcome these issues. Three basal insulin analogs are currently in the market in Europe. PEGylated insulin lispro is a new second-generation basal insulin analog which most likely will undergo review in 2016 by the US FDA and EMA in Europe for possible approval for marketing. Phase III trials are finalized, but not yet published. Phase II studies suggest antiglycemic efficacy, possible with a preferential hepato-specific action, a low rate of hypoglycemia, minor weight loss and acceptable tolerability. The benefit-risk profile needs, however, to be established.
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Affiliation(s)
- Michael E Røder
- a Center for Diabetes Research, Department of Medicine F, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
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Lim PC, Chong CP. What's next after metformin? focus on sulphonylurea: add-on or combination therapy. Pharm Pract (Granada) 2015; 13:606. [PMID: 26445623 PMCID: PMC4582747 DOI: 10.18549/pharmpract.2015.03.606] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2015] [Accepted: 07/28/2015] [Indexed: 12/11/2022] Open
Abstract
Introduction: The pathophysiology of type 2 diabetes (T2DM) mainly focused on insulin resistance and insulin deficiency over the past decades. Currently, the pathophysiologies expanded to ominous octet and guidelines were updated with newer generation of antidiabetic drug classes. However, many patients had yet to achieve their target glycaemic control. Although all the guidelines suggested metformin as first line, there was no definite consensus on the second line drug agents as variety of drug classes were recommended. Objectives: The aim of this review was to evaluate the drug class after metformin especially sulphonylurea and issues around add-on or fixed dose combination therapy. Methods: Extensive literature search for English language articles, clinical practice guidelines and references was performed using electronic databases. Results: Adding sulphonylurea to metformin targeted both insulin resistance and insulin deficiency. Sulphonylurea was efficacious and cheaper than thiazolidinedione, dipeptidyl peptidase-4 inhibitor, glucagon-like peptide 1 analogue and insulin. The main side effect of sulphonylurea was hypoglycaemia but there was no effect on the body weight when combining with metformin. Fixed dose sulphonylurea/metformin was more efficacious at lower dose and reported to have fewer side effects with better adherence. Furthermore, fixed dose combination was cheaper than add-on therapy. In conclusion, sulphonylurea was feasible as the second line agent after metformin as the combination targeted on two pathways, efficacious, cost-effective and had long safety history. Fixed dose combination tablet could improve patient’s adherence and offered an inexpensive and more efficacious option regardless of original or generic product as compared to add-on therapy.
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Affiliation(s)
- Phei C Lim
- Department of Pharmacy, Hospital Pulau Pinang. Penang ( Malaysia ).
| | - Chee P Chong
- Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sain Malaysia . Penang ( Malaysia ).
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Barkas F, Liberopoulos E, Klouras E, Liontos A, Elisaf M. Attainment of multifactorial treatment targets among the elderly in a lipid clinic. J Geriatr Cardiol 2015; 12:239-45. [PMID: 26089847 PMCID: PMC4460166 DOI: 10.11909/j.issn.1671-5411.2015.03.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2014] [Revised: 01/21/2015] [Accepted: 03/02/2015] [Indexed: 11/21/2022] Open
Abstract
OBJECTIVE To examine target attainment of lipid-lowering, antihypertensive and antidiabetic treatment in the elderly in a specialist setting of a University Hospital in Greece. METHODS This was a retrospective study including consecutive subjects ≥ 65 years old (n = 465) with a follow-up ≥ 3 years. Low-density lipoprotein cholesterol (LDL-C), blood pressure (BP) and glycated hemoglobin (HbA1c) goal achievement were recorded according to European Society of Cardiology/European Atherosclerosis Society (ESC/EAS), European Society of Hypertension (ESH)/ESC and European Association for the Study of Diabetes (EASD) guidelines. RESULTS The LDL-C targets were attained by 27%, 48% and 62% of very high, high and moderate risk patients, respectively. Those receiving statin + ezetimibe achieved higher rates of LDL-C goal achievement compared with those receiving statin monotherapy (48% vs. 33%, P < 0.05). Of the diabetic subjects, 71% had BP < 140/85 mmHg, while 78% of those without diabetes had BP < 140/90 mmHg. A higher proportion of the non-diabetic individuals (86%) had BP < 150/90 mmHg. Also, a higher proportion of those with diabetes had HbA1c < 8% rather than < 7% (88% and 47%, respectively). Of note, almost one out of three non-diabetic individuals and one out of ten diabetic individuals had achieved all three treatment targets. CONCLUSIONS Even in a specialist setting of a University Hospital, a high proportion of the elderly remain at suboptimal LDL-C, BP and HbA1c levels. The use of drug combinations could improve multifactorial treatment target attainment, while less strict targets could be more easily achieved in this population.
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Affiliation(s)
- Fotios Barkas
- Department of Internal Medicine, University of Ioannina Medical School, Ioannina, Greece
| | - Evangelos Liberopoulos
- Department of Internal Medicine, University of Ioannina Medical School, Ioannina, Greece
| | - Eleftherios Klouras
- Department of Internal Medicine, University of Ioannina Medical School, Ioannina, Greece
| | - Angelos Liontos
- Department of Internal Medicine, University of Ioannina Medical School, Ioannina, Greece
| | - Moses Elisaf
- Department of Internal Medicine, University of Ioannina Medical School, Ioannina, Greece
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Capoccia D, Coccia F, Guida A, Rizzello M, De Angelis F, Silecchia G, Leonetti F. Is type 2 diabetes really resolved after laparoscopic sleeve gastrectomy? Glucose variability studied by continuous glucose monitoring. J Diabetes Res 2015; 2015:674268. [PMID: 25954762 PMCID: PMC4411432 DOI: 10.1155/2015/674268] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/11/2015] [Revised: 03/19/2015] [Accepted: 03/20/2015] [Indexed: 02/06/2023] Open
Abstract
The study was carried out on type 2 diabetic obese patients who underwent laparoscopic sleeve gastrectomy (LSG). Patients underwent regular glycemic controls throughout 3 years and all patients were defined cured from diabetes according to conventional criteria defined as normalization of fasting glucose levels and glycated hemoglobin in absence of antidiabetic therapy. After 3 years of follow-up, Continuous Glucose Monitoring (CGM) was performed in each patient to better clarify the remission of diabetes. In this study, we found that the diabetes resolution after LSG occurred in 40% of patients; in the other 60%, even if they showed a normal fasting glycemia and A1c, patients spent a lot of time in hyperglycemia. During the oral glucose tolerance test (OGTT), we found that 2 h postload glucose determinations revealed overt diabetes only in a small group of patients and might be insufficient to exclude the diagnosis of diabetes in the other patients who spent a lot of time in hyperglycemia, even if they showed a normal glycemia (<140 mg/dL) at 120 minutes OGTT. These interesting data could help clinicians to better individualize patients in which diabetes is not resolved and who could need more attention in order to prevent chronic complications of diabetes.
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Affiliation(s)
- D. Capoccia
- Department of Experimental Medicine, Division of Diabetes and Metabolic Diseases, Policlinico Umberto I, 00161 Rome, Italy
| | - F. Coccia
- Department of Experimental Medicine, Division of Diabetes and Metabolic Diseases, Policlinico Umberto I, 00161 Rome, Italy
| | - A. Guida
- Department of Experimental Medicine, Division of Diabetes and Metabolic Diseases, Policlinico Umberto I, 00161 Rome, Italy
| | - M. Rizzello
- Department of Medical Surgical Sciences and Biotechnology, Division of General Surgery, ICOT, Sapienza University of Rome, 04100 Latina, Italy
| | - F. De Angelis
- Department of Medical Surgical Sciences and Biotechnology, Division of General Surgery, ICOT, Sapienza University of Rome, 04100 Latina, Italy
| | - G. Silecchia
- Department of Medical Surgical Sciences and Biotechnology, Division of General Surgery, ICOT, Sapienza University of Rome, 04100 Latina, Italy
| | - F. Leonetti
- Department of Experimental Medicine, Division of Diabetes and Metabolic Diseases, Policlinico Umberto I, 00161 Rome, Italy
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Walraven I, Mast MR, Hoekstra T, Jansen APD, van der Heijden AAWA, Rauh SP, Rutters F, van 't Riet E, Elders PJM, Moll AC, Polak BCP, Dekker JM, Nijpels G. Distinct HbA1c trajectories in a type 2 diabetes cohort. Acta Diabetol 2015; 52:267-75. [PMID: 25287012 DOI: 10.1007/s00592-014-0633-8] [Citation(s) in RCA: 45] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2014] [Accepted: 07/15/2014] [Indexed: 12/14/2022]
Abstract
AIMS The aim of this study was to identify subgroups of type 2 diabetes mellitus patients with distinct hemoglobin A1c (HbA1c) trajectories. Subgroup characteristics were determined and the prevalence of microvascular complications over time was investigated. STUDY DESIGN AND SETTING Data from a cohort of 5,423 type 2 diabetes patients from a managed primary care system were used [mean follow-up 5.7 years (range 2-9 years)]. Latent class growth modeling was used to identify subgroups of patients with distinct HbA1c trajectories. Multinomial logistic regression analyses were conducted to determine which characteristics were associated with different classes. RESULTS Four subgroups were identified. The first and largest subgroup (83 %) maintained good glycemic control over time (HbA1c ≤53 mmol/mol), the second subgroup (8 %) initially showed severe hyperglycemia, but reached the recommended HbA1c target within 2 years. Patients within this subgroup had significantly higher baseline HbA1c levels but were otherwise similar to the good glycemic control group. The third subgroup (5 %) showed hyperglycemia and a delayed response without reaching the recommended HbA1c target. The fourth subgroup (3.0 %) showed deteriorating hyperglycemia over time. Patients within the last two subgroups were significantly younger, had higher HbA1c levels and a longer diabetes duration at baseline. These subgroups also showed a higher prevalence of retinopathy and microalbuminuria. CONCLUSION Four subgroups with distinct HbA1c trajectories were identified. More than 90 % reached and maintained good glycemic control (subgroup one and two). Patients within the two subgroups that showed a more unfavorable course of glycemic control were younger, had higher HbA1c levels and a longer diabetes duration at baseline.
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Affiliation(s)
- Iris Walraven
- EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands,
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Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of Multiple Doses of Albiglutide on the Pharmacokinetics, Pharmacodynamics, and Safety of Digoxin, Warfarin, or a Low-Dose Oral Contraceptive. Postgrad Med 2015; 124:55-72. [DOI: 10.3810/pgm.2012.11.2613] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
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Avramopoulos I, Moulis A, Nikas N. Glycaemic control, treatment satisfaction and quality of life in type 2 diabetes patients in Greece: The PANORAMA study Greek results. World J Diabetes 2015; 6:208-16. [PMID: 25685292 PMCID: PMC4317314 DOI: 10.4239/wjd.v6.i1.208] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2014] [Revised: 11/24/2014] [Accepted: 12/16/2014] [Indexed: 02/05/2023] Open
Abstract
AIM To provide an update on glycaemic control in European patients with type 2 diabetes mellitus (T2DM). We present the Greek population data of the study. METHODS An observational multicenter, cross-sectional study evaluating glycaemic control and a range of other clinical and biological measures as well as quality of life (QoL) and treatment satisfaction in 375 patients with T2DM enrolled by 25 primary care sites from Greece. RESULTS The mean age of the patients was 63.5 years and the male/female ratio 48.9%/51.1%. 79.7% of the patients exerted none or light physical activity, 82.4% were overweight or obese and 32.9% did not meet HbA1c target of less than 7.0% (53 mmol/mol). Patients reported high satisfaction to continue with treatment, high satisfaction with administered treatment and increased willingness to recommend treatment to others (mean Diabetes Treatment Satisfaction Questionnaire score 29.1 ± 5.6). However, 80% of the patients reported that their QoL would be better without diabetes. Finally, the most challenging parameter reported was the lack of freedom to eat and drink. CONCLUSION This analysis of the Greek Panorama study results showed that a considerable percentage of T2DM patients in Greece do not achieve glycaemic target levels, despite the favourably reported patient satisfaction from administered therapy. Additionally, the majority of primary care T2DM patients in Greece depict the negative effect of the disease in their QoL.
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Franch-Nadal J, Roura-Olmeda P, Benito-Badorrey B, Rodriguez-Poncelas A, Coll-de-Tuero G, Mata-Cases M. Metabolic control and cardiovascular risk factors in type 2 diabetes mellitus patients according to diabetes duration. Fam Pract 2015; 32:27-34. [PMID: 25194144 DOI: 10.1093/fampra/cmu048] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/14/2022] Open
Abstract
BACKGROUND Control of glycaemic levels as well as cardiovascular risk factors (CVRF) is essential to prevent the onset of complications associated with type 2 diabetes mellitus (T2DM). AIM To describe the degree of glycaemic control and CVRF in relation to diabetes duration. PATIENTS AND METHODS Multicentre cross-sectional study in T2DM patients seen in primary care centres during 2007. VARIABLES Demographical and clinical characteristics, antidiabetic treatments and development of disease complications. Diabetes duration classification: 0-5, 6-10, 11-20 and >20 years. Logistic regression models were used in the analysis. RESULTS A total of 3130 patients; 51.5% males; mean age: 68±11.7 years; mean diabetes duration:7.0 (±5.6) years, median: 5 (interquartile range:3-9) years; mean HbA1c: 6.84 (±1.5), were analyzed. There has been a progressive decline in HbA1c levels (HbA1c > 7% in 25.8% of patients during the first 5 years and 51.8% after 20 years). Blood pressure values remained relatively stable throughout disease duration. The mean value of low density lipoprotein (LDL) experienced a slight decline with the progression of the disease, but due to the significant increase of cardiovascular disease (CVD) after 20 years of duration, less patients reached the recommended target (LDL < 100mg/dl) in secondary prevention. Logistic regression model controlling for age, sex and CVD showed that diabetes duration was related to glycaemic control (odds ratio: 1.066, 95% confidence interval: 1.050-1.082 per year) but not to blood pressure or LDL control. CONCLUSIONS The degree of glycaemic control and the risk factors in relation to the duration of T2DM followed different patterns. Diabetes duration was associated with a poorer glycaemic control but in general had a limited role in blood pressure control or lipid profile.
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Affiliation(s)
- Josep Franch-Nadal
- Primary Care Center Raval Sud, Barcelona, Spain; Barcelona Ciutat Research Support Unit - IDIAP Jordi Gol, Barcelona, Spain;
| | | | | | | | - Gabriel Coll-de-Tuero
- PCC Anglés, Girona, Spain; Research Unit, Healthcare Institute, Girona, Spain; Translab. Departament of Medical Sciences, University of Girona, Girona, Spain and
| | - Manel Mata-Cases
- Barcelona Ciutat Research Support Unit - IDIAP Jordi Gol, Barcelona, Spain; PCC La Mina, Sant Adrià de Besòs, Barcelona, Spain
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Khosravizade Tabasi H, Madarshahian F, Khoshniat Nikoo M, Hassanabadi M, Mahmoudirad G. Impact of family support improvement behaviors on anti diabetic medication adherence and cognition in type 2 diabetic patients. J Diabetes Metab Disord 2014; 13:113. [PMID: 25436202 PMCID: PMC4247652 DOI: 10.1186/s40200-014-0113-2] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/13/2014] [Accepted: 11/11/2014] [Indexed: 01/03/2023]
Abstract
BACKGROUND Glycaemic control is the main goal of treatment for type 2 diabetic patients. Hyperglycaemia may result in cognitive decline. More family support may increase medication adherence and decrease glycaemic level. The purpose of this study was to determine the impact of family support improvement behavior on anti diabetic medication adherence and cognition in type 2 diabetic patients. METHOD The randomized control trial study was conducted on 91 patients from an outpatient diabetes clinic. They were randomly divided to intervention (n = 45) and control (n = 46) group. Data on the patients' demographic information and their family gathered using a questionnaire, For two groups Morisky Medication Adherence Scale (MMAS), drug administration part of Diabetes Social Support Questionnaire - family version (DSSQ), Number Connection Test (NCT) were applied and hemoglobin A1C was measured two times in the onset of study and three months later for control group and before and after intervention for intervention group. The key family members of the intervention group were taught according to their educational needs in small groups. RESULT In intervention group mean of NCT score was significantly decreased after intervention (P = 0.006) however in the control group there was no significant difference after three months. In intervention group a significant correlation was noted between DSSQ scores and MMAS scores after intervention(r =0.67, P < 0.001) but, there was no significant correlation in the control group. CONCLUSION Family support instruction based on the educational needs of family members, may improve medication adherence through direct effect and cognitive status with indirect effect.
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Affiliation(s)
| | - Farah Madarshahian
- />Birjand University of Medical Sciences, Ghafary Ave., Birjand, 9717853577 Iran
| | - Mohsen Khoshniat Nikoo
- />Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, North Kargar Street, Tehran, 1411413137 Iran
| | - Mohsen Hassanabadi
- />Birjand University of Medical Sciences, Ghafary Ave., Birjand, 9717853577 Iran
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Wilke T, Groth A, Fuchs A, Seitz L, Kienhöfer J, Lundershausen R, Maywald U. Real life treatment of diabetes mellitus type 2 patients: an analysis based on a large sample of 394,828 German patients. Diabetes Res Clin Pract 2014; 106:275-85. [PMID: 25176225 DOI: 10.1016/j.diabres.2014.08.002] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2014] [Revised: 05/23/2014] [Accepted: 08/03/2014] [Indexed: 11/19/2022]
Abstract
OBJECTIVES The aim of this claims-based data analysis was to describe the care of German T2DM patients and to determine which subgroups could be differentiated in terms of the achieved T2DM-related treatment results, the underlying comorbidities, and the achieved comorbidity-related treatment results. METHODS We included all T2DM patients insured by a large sickness fund in 2010/2011. We defined 12 subgroups according to observed HbA1C, blood pressure and Charlson Comorbidity Index (CCI). For each subgroup, available sociodemographic and clinical information were reported. Different treatment variables were described. T2DM-related events leading to acute hospitalisations were reported. RESULTS We included 394,828 T2DM patients in our analysis; for 228,703 patients' detailed data as basis for subgroup classification were available. For 4.5% of these patients, a HbA1C >9% was observed. 21,833 of the T2DM patients were affected by a T2DM-related event; the risk was 5.53% per patient year; 1.74% of the patients suffered from more than one event. Most frequent event types were hospitalisation with T2DM as primary diagnosis (2.39%), vascular interventions/stent implantations (1.92%), and ischaemic stroke (1.19%). There were significant differences between the observed subgroups in terms of T2DM-related event risk. CONCLUSION Overall, our data indicate that the typically treated T2DM patient has a number of comorbidities and thus treatment focused solely on T2DM is neither possible nor clinically meaningful. Particularly those patients who reached HbA1C goals, but had also achieved relevant additional treatment goals reached low yearly T2DM event rates whereas subgroups failing to achieve one or several treatment goals are facing much higher event risks.
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Affiliation(s)
- Thomas Wilke
- Institut für Pharmakoökonomie und Arzneimittellogistik (IPAM), Hochschule Wismar, Germany.
| | - Antje Groth
- Institut für Pharmakoökonomie und Arzneimittellogistik (IPAM), Hochschule Wismar, Germany
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Nauck MA, Del Prato S, Durán-García S, Rohwedder K, Langkilde AM, Sugg J, Parikh SJ. Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin. Diabetes Obes Metab 2014; 16:1111-20. [PMID: 24919526 DOI: 10.1111/dom.12327] [Citation(s) in RCA: 82] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2014] [Revised: 04/28/2014] [Accepted: 06/05/2014] [Indexed: 01/10/2023]
Abstract
AIMS To assess the long-term glycaemic durability, safety and tolerability of dapagliflozin versus glipizide as add-on therapies in patients with type 2 diabetes inadequately controlled by metformin alone. METHODS This was a 52-week, randomised, double-blind study of dapagliflozin (n = 406) versus glipizide (n = 408), uptitrated over 18 weeks according to tolerability and glycaemic response to a maximum of 10 and 20 mg/day, respectively, as add-on therapies to metformin (≥ 1500 mg/day) with a 156-week double-blind extension period. Data over 104 weeks are reported here. RESULTS In total, 53.1% of patients completed 104 weeks of treatment. After the greater initial decrease (0-18 weeks) in glycated haemoglobin (HbA1c) with glipizide, the 18-104-week HbA1c coefficient of failure (CoF) was lower with dapagliflozin (0.13%/year) than with glipizide (0.59%/year), resulting in significant dapagliflozin versus glipizide differences of -0.46%/year (95% CI -0.60,-0.33; p = 0.0001) for CoF and -0.18%(-2.0 mmol/mol) [95% CI -0.33(-3.6),-0.03(-0.3); p = 0.021] for 104-week HbA1c. Dapagliflozin produced sustained reductions in weight and systolic blood pressure, whereas glipizide increased weight and systolic blood pressure, giving 104-week dapagliflozin versus glipizide differences of -5.1 kg (95% CI: -5.7,-4.4) and -3.9 mmHg (95% CI: -6.1,-1.7), respectively. Over 104 weeks, the hypoglycaemia rate was 10-fold lower with dapagliflozin than with glipizide (4.2 vs. 45.8%), whereas patient proportions with events suggestive of genital infection and of urinary tract infection (UTI) were greater with dapagliflozin (14.8 and 13.5%, respectively) than with glipizide (2.9 and 9.1%, respectively). CONCLUSIONS Over 2 years, compared with glipizide, dapagliflozin demonstrated greater glycaemic durability, sustained reductions in weight and systolic blood pressure and a low hypoglycaemia rate; however, genital infections and UTIs occurred more frequently.
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Affiliation(s)
- M A Nauck
- Diabetes Centre, Bad Lauterberg, Germany
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Pok EH, Lee WJ. Gastrointestinal metabolic surgery for the treatment of type 2 diabetes mellitus. World J Gastroenterol 2014; 20:14315-28. [PMID: 25339819 PMCID: PMC4202361 DOI: 10.3748/wjg.v20.i39.14315] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/28/2013] [Revised: 03/07/2014] [Accepted: 05/29/2014] [Indexed: 02/06/2023] Open
Abstract
Medical therapy for type 2 diabetes mellitus is ineffective in the long term due to the progressive nature of the disease, which requires increasing medication doses and polypharmacy. Conversely, bariatric surgery has emerged as a cost-effective strategy for obese diabetic individuals; it has low complication rates and results in durable weight loss, glycemic control and improvements in the quality of life, obesity-related co-morbidity and overall survival. The finding that glucose homeostasis can be achieved with a weight loss-independent mechanism immediately after bariatric surgery, especially gastric bypass, has led to the paradigm of metabolic surgery. However, the primary focus of metabolic surgery is the alteration of the physio-anatomy of the gastrointestinal tract to achieve glycemic control, metabolic control and cardio-metabolic risk reduction. To date, metabolic surgery is still not well defined, as it is used most frequently for less obese patients with poorly controlled diabetes. The mechanism of glycemic control is still incompletely understood. Published research findings on metabolic surgery are promising, but many aspects still need to be defined. This paper examines the proposed mechanism of diabetes remission, the efficacy of different types of metabolic procedures, the durability of glucose control, and the risks and complications associated with this procedure. We propose a tailored approach for the selection of the ideal metabolic procedure for different groups of patients, considering the indications and prognostic factors for diabetes remission.
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Murad MA, Abdulmageed SS, Iftikhar R, Sagga BK. Assessment of the common risk factors associated with type 2 diabetes mellitus in jeddah. Int J Endocrinol 2014; 2014:616145. [PMID: 25548563 PMCID: PMC4165874 DOI: 10.1155/2014/616145] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2014] [Revised: 06/10/2014] [Accepted: 06/11/2014] [Indexed: 02/08/2023] Open
Abstract
Risk factor management is important in avoiding life-threatening complications and preventing new-onset diabetes. We performed a case-control study in 2013 at ten primary health care centers in Jeddah, Saudi Arabia to determine the common risk factors of diabetes mellitus type 2 (DM2) and the demographic background of adult Saudi patients with DM2. Known diabetic patients were recruited as cases, while nondiabetic attendants were selected as controls. A pretested designed questionnaire was used to collect data from 159 cases and 128 controls. Cases were more likely than controls to be men (P < 0.0001), less educated (P < 0.0001), natives of eastern Saudi Arabia (P < 0.0001), retired (P < 0.0001), lower-salaried (P < 0.0001), or married or divorced (P < 0.0001). By univariate analysis cases were likely to be current smokers (P < 0.0001), hypertensive (P < 0.0001), or overweight/obese (P < 0.0001). Cases were also more likely to have a history of DM in a first-degree relative (P = 0.020). By multivariate analysis, cases were more likely to be older than 40 years (P < 0.0001), less educated (P = 0.05), married or divorced (P = 0.04), jobless/housewives (P < 0.0001), or current smokers (P = 0.002). They were also more likely to have salaries <7000 Saudi riyals (P = 0.01). Overall, prediabetic and high risk groups should be identified and counseled early before the occurrence of diabetes.
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Affiliation(s)
- Manal A. Murad
- Department of Family and Community Medicine, King Abdulaziz University, P.O. Box 42806, Jeddah 21551, Saudi Arabia
| | | | - Rahila Iftikhar
- Department of Family and Community Medicine, King Abdulaziz University, P.O. Box 42806, Jeddah 21551, Saudi Arabia
| | - Bayan Khaled Sagga
- Health Promotion Management Master's Program, College of Arts and Sciences, American University, Washington, DC, USA
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Derosa G, Maffioli P. Diabetes: safety and efficacy of albiglutide-results from two trials. Nat Rev Endocrinol 2014; 10:514-6. [PMID: 25069463 DOI: 10.1038/nrendo.2014.126] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
Type 2 diabetes mellitus is associated with a poor quality of life and considerable health-care costs and can be difficult to control. The recent results from the HARMONY 3 and HARMONY 6 trials suggest that albiglutide is a safe and effective treatment option for patients with type 2 diabetes mellitus.
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Affiliation(s)
- Giuseppe Derosa
- Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico S. Matteo, P le C. Golgi 2, 27100 Pavia, Italy
| | - Pamela Maffioli
- Department of Internal Medicine and Therapeutics, University of Pavia and Fondazione IRCCS Policlinico S. Matteo, P le C. Golgi 2, 27100 Pavia, Italy
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Garber AJ. Will the next generation of basal insulins offer clinical advantages? Diabetes Obes Metab 2014; 16:483-91. [PMID: 24118819 DOI: 10.1111/dom.12219] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/09/2013] [Revised: 09/29/2013] [Accepted: 09/29/2013] [Indexed: 11/28/2022]
Abstract
The 21st century has seen the arrival of several insulin analogue products and the refinement of insulin regimens, with widespread advocacy of continuous titration algorithms and earlier initiation of supplementary insulin therapy (predominantly using basal insulins) in type 2 diabetes. Nevertheless, many insulin-treated diabetes patients remain in poor glycaemic control. This might reflect insufficient titration effort or lax adherence, but these issues could in some cases result from concerns about hypoglycaemia. Certainly there is scope for improving the pharmacokinetic/pharmacodynamic (PK/PD) profile of basal insulin, and three new products offer this prospect. Insulin degludec, now in clinical use, and PEGylated insulin lispro, in development, have greatly extended action profiles that result from two very different, but unique, mechanisms. With once-daily dosing, these insulins produce stable PK/PD profiles at steady state, associated with a low incidence of hypoglycaemia. The feasibility of varied daily dose timing has also been confirmed with insulin degludec. High strength formulations of insulin glargine and insulin degludec offer the prospect of a reduced injection number/volume in high dose users, and in the case of glargine, the PK/PD profile might also be favourably modified. This review considers critically the clinical evidence and expectations we should have for these new basal insulins.
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Affiliation(s)
- A J Garber
- Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, USA
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Sun YN, Zhou Y, Chen X, Che WS, Leung SW. The efficacy of dapagliflozin combined with hypoglycaemic drugs in treating type 2 diabetes mellitus: meta-analysis of randomised controlled trials. BMJ Open 2014; 4:e004619. [PMID: 24710132 PMCID: PMC3987716 DOI: 10.1136/bmjopen-2013-004619] [Citation(s) in RCA: 57] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
OBJECTIVES This meta-analysis aimed to evaluate whether dapagliflozin is synergistic with other antidiabetic drugs without body weight gain. SETTING Randomised controlled trial (RCT) reports were retrieved from PubMed, Cochrane Library, EMBASE, ClinicalTrials.gov, Google Scholar and Google. Eligible RCTs were selected according to the criteria (including types of participants, intervention, outcomes) and assessed by the Cochrane risk of bias tool and GRADEpro software for evidential quality. Meta-analysis on the eligible RCTs was performed with the random effects model. The RCTs of low-quality and interim stages were excluded for further sensitivity analysis. Meta-regression was conducted on the follow-up durations. Publication bias was evaluated with funnel plots and the Egger's regression test and adjusted using the trim-and-fill procedure. Heterogeneity was assessed with the I(2) statistics. PARTICIPANTS Adult patients with type 2 diabetes mellitus (T2DM). INTERVENTIONS Dapagliflozin combined with conventional antidiabetic drugs. PRIMARY AND SECONDARY OUTCOME MEASURES Glycaemic level (measured by glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG)) and body weight. RESULTS 12 RCTs were eligible for quantitative synthesis and meta-analysis. The overall effect size of HbA1c calculated from mean difference was -0.52% (Z=-13.56, p<0.001) with 95% CI (-0.60 to -0.45). The effect size of FPG was -1.13 mmol/L (Z=-11.12, p<0.001) with 95% CI (-1.33 to -0.93). The effect size of body weight was -2.10 kg (Z=-18.77, p<0.001) with 95% CI (-2.32 to -1.88). Exclusions of low quality and interim RCTs changed the overall mean differences respectively to -0.56%, -1.11 mmol/L, 2.23 kg and -0.50%, -1.08 mmol/L, -2.08 kg. The sensitivity analysis indicated good robustness of the meta-analysis on HbA1c, FPG and body weight. CONCLUSIONS The meta-analysis showed that dapagliflozin as an add-on drug to conventional antidiabetic drugs improved the glycaemic control in T2DM participants without significant body weight gain. TRIAL REGISTRATION NUMBER CRD42013005034.
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Affiliation(s)
- Yu-nan Sun
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Yi Zhou
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Xi Chen
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Weng-si Che
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Siu-wai Leung
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
- School of Informatics, University of Edinburgh, Edinburgh, Scotland, UK
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Rodríguez A, Tofe S, Reviriego J. Clinical course after five years of insulin therapy in patients with type 2 diabetes in Spain: results of the EDIN study. ACTA ACUST UNITED AC 2014; 61:369-76. [PMID: 24685227 DOI: 10.1016/j.endonu.2014.02.003] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2013] [Revised: 01/31/2014] [Accepted: 02/03/2014] [Indexed: 11/19/2022]
Abstract
OBJECTIVES The primary study objective was to assess the proportion of patients with type 2 diabetes and an HbA1c value ≤ 6.5% from the start of insulin therapy to five years later in the outpatient setting in Spain. MATERIAL AND METHODS This was an observational, multicenter, naturalistic study with retrospective collection of clinical data. Investigators were endocrinologists or internal medicine specialists from all over Spain. During standard clinical care, patients started insulin therapy, which was continued for at least 5 years. RESULTS The clinical records of 405 patients were reviewed. The final analysis set included records from 346 patients. At baseline (start of insulin therapy), 51.2% of patients were female; mean (SD) age was 64.6 (9.0) years; body mass index, 29.8 (4-5) kg/m(2); time since diagnosis, 8.8 (6.8) years; HbA1c, 9.4% (1.5); fasting glucose, 223.7 (55.9) mg/dL; and mean 2-hour postprandial glucose, 293.6 (71.0) mg/dL. When insulin therapy was started, <1.0% of patients had an HbA1c value ≤ 6.5%. At 5 years, 10.3% of patients achieved the HbA1c goal of ≤ 6.5% (mean, 7.72%). All glucose parameters (HbA1c, fasting glucose, and 2-hour postprandial glucose) improved at 5 years as compared to values at the start of insulin therapy. CONCLUSIONS Glucose parameters improved over time in patients with type 2 diabetes in this naturalistic study. However, blood glucose control exceeded the internationally recommended target values. These results therefore suggest that there is still some margin for improvement in outpatient care in Spain.
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Affiliation(s)
| | - Santiago Tofe
- Departamento de Endocrinología y Nutrición, Hospital Universitario Son Espases, Mallorca, España
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Abruzzese E, Breccia M, Latagliata R. Second-generation tyrosine kinase inhibitors in first-line treatment of chronic myeloid leukaemia (CML). BioDrugs 2014; 28:17-26. [PMID: 24043361 DOI: 10.1007/s40259-013-0056-z] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Abstract
Tyrosine kinase inhibitors (TKIs) have contributed to marked improvements in survival in patients with chronic myeloid leukaemia (CML). This article discusses the place of the second-generation TKIs dasatinib and nilotinib in the first-line treatment of CML and is based on published literature. The new agents are more potent and effective than imatinib. Data from pivotal clinical trials indicate that response to dasatinib and nilotinib is greater and more rapid than that to imatinib, resulting in a higher probability of patients achieving an optimal response to treatment. Differences between the newer agents with respect to patient groups for whom caution is advised, drug interaction potential, haematological toxicity, pulmonary toxicity, changes in the immune system and effects on laboratory parameters are discussed. With similar levels of efficacy, the choice of second-generation agents should be guided by the characteristics of the individual patient and the most suitable dosing regimen.
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Affiliation(s)
- Elisabetta Abruzzese
- Hematology, S. Eugenio Hospital, Tor Vergata University, P. le dell'Umanesimo 10, 00144, Rome, Italy,
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de Pablos-Velasco P, Parhofer KG, Bradley C, Eschwège E, Gönder-Frederick L, Maheux P, Wood I, Simon D. Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin Endocrinol (Oxf) 2014. [PMID: 23194193 DOI: 10.1111/cen.12119] [Citation(s) in RCA: 149] [Impact Index Per Article: 13.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/02/2023]
Abstract
OBJECTIVE To provide an update on glycaemic control in European patients with type 2 diabetes based on data from the nine-country, cross-sectional PANORAMA study (NCT00916513). DESIGN Post-hoc analysis to report the number of patients achieving/not achieving glycaemic goal (HbA(1c) <7%). PATIENTS Patients were randomly or consecutively selected from physician practices in nine countries. Eligible patients were aged ≥40 years, diagnosed with type 2 diabetes >1 year prior to study entry, and had an available medical record of >1 year. MEASUREMENTS All data were collected at a single visit, including HbA1c measurement using a common device (A1CNow). Bivariate and multivariate analyses were used to investigate factors associated with not reaching glycaemic goal. RESULTS Of 5817 patients enrolled (aged 65·9 ± 10·4 years, 53·7% male), 37·4% had an HbA(1c) ≥7%; (range 25·9% in The Netherlands to 52·0% in Turkey). In adjusted multivariate analyses, higher individual glycaemic target, younger age, poor physician-reported patient adherence to lifestyle/medication, longer diabetes duration, increasing treatment regimen complexity and physician-reported patient's unwillingness to intensify treatment were associated with not achieving goal. However, bivariate analyses also found gender, socioeconomic factors, body mass index, rate of complications and hypoglycaemia to be associated with not achieving goal. CONCLUSIONS In PANORAMA, 37·4% of patients enrolled were not at glycaemic goal. Factors relating to patient characteristics, physician selection of individualized HbA1c target and diabetes itself (longer duration, more complex treatment) were strongly associated with not achieving goal. Further studies are warranted to explore these associations and evaluate strategies for improving glycaemic control.
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Sun YN, Zhou Y, Chen X, Che WS, Leung SW. The efficacy of dapagliflozin combined with hypoglycemic drugs in treating type 2 diabetes: protocol for meta-analysis of randomized controlled trials. Syst Rev 2013; 2:103. [PMID: 24225054 PMCID: PMC3833641 DOI: 10.1186/2046-4053-2-103] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2013] [Accepted: 11/04/2013] [Indexed: 01/10/2023] Open
Abstract
BACKGROUND Dapagliflozin is a first-in-class oral sodium glucose co-transporter 2 (SGLT2) inhibitor. It is often used in combination with conventional anti-diabetic drugs such as metformin, glimepiride, and insulin in treating type 2 diabetes (T2D). It not only reduces glucose reabsorption in the kidney but also increases renal glucose excretion. Some studies found the actions of dapagliflozin independent of insulin and free from risk of weight gain. This meta-analysis aims to evaluate whether dapagliflozin is synergistic with other anti-diabetic drugs without risk of weight gain. METHODS/DESIGN This meta-analysis will include the randomized controlled trials (RCT) evaluating the efficacy of dapagliflozin as an add-on drug in treating T2D for >8 weeks with the outcome measures glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG) and body weight. Information of relevant RCTs will be retrieved from major databases including PubMed, Cochrane Library, Embase, ClinicalTrials.gov, and Google Scholar according to a pre-specified search strategy. Google and manual search will find other unpublished reports and supplementary data. Eligible RCTs will be selected according to pre-specified inclusion and exclusion criteria. Data will be extracted and input into a pre-formatted spreadsheet. The Cochrane risk of bias tool will be used to assess the quality of the eligible RCTs. Meta-analysis based on the random-effects model will be conducted to compare the changes of HbA1c (%), FPG (mmol/L), and body weight (kg) between dapagliflozin arm and placebo arm. Publication bias will be evaluated with a funnel plot and the Egger's test. Heterogeneity will be assessed with the I2 statistics. Sensitivity analysis will be conducted on follow-up periods. The evidential quality of the findings will be assessed with the GRADE profiler. DISCUSSION The findings of this meta-analysis will be important to clinicians, patients, and health policy-makers regarding the use of dapagliflozin in T2D treatment. STUDY REGISTRATION PROSPERO registration number: CRD42013005034.
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Affiliation(s)
- Yu-nan Sun
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Yi Zhou
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Xi Chen
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Wen-si Che
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
| | - Siu-wai Leung
- State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
- School of Informatics, University of Edinburgh, Edinburgh, United Kingdom
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Braun gastrointestinal bypass surgery exerts similar hypoglycemic effects, with minimal operation time and earlier functional recovery, than Roux-en-Y bypass in type 2 diabetic rats. Obes Surg 2013; 24:171-8. [PMID: 24178369 DOI: 10.1007/s11695-013-1102-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]
Abstract
BACKGROUND Despite the beneficial hypoglycemic and potentially curative effects in type 2 diabetes, large stomach volume deficits caused by Roux-en-Y gastrointestinal bypass (RYGB) surgery increase complications. Hypoglycemic effects of Braun surgery and RYGB surgery, both modified to maximally preserve stomach volume, were compared in rat type 2 diabetes models. METHODS Three-month-old, male Goto-Kakizaki (GK) rats (n = 40) were randomly divided into equal groups and not treated (control) or treated with sham surgery (sham group), modified stomach-preserving Braun gastrointestinal bypass (Braun group), or modified RYGB (RYGB group). Pre- and postoperative body weight and water intake were recorded, along with operative and defecation times. Fasting blood glucose at 12 h, and blood glucose 180 min after intragastric glucose administration, were measured at weeks 1, 2, 3, 4, 10, and 11 along with glycosylated hemoglobin (preoperatively, week 11). RESULTS Statistically similar (P > 0.05) increased body weight and decreased water intake, fasting blood glucose, blood glucose after intragastric glucose administration, and glycosylated hemoglobin were observed in Braun and RYGB groups compared with control and sham groups (P < 0.05). By week 1, RYGB and Braun groups exhibited sustained reductions in fasting blood glucose from 13.0 ± 4.1 to 6.9 ± 1.4 mmol/L and 12.4 ± 4.4 to 7.3 ± 0.9 mmol/L, respectively (P < 0.05); mean operative times were 139.1 ± 4.9 and 81.6 ± 6.4 min, respectively; and postoperative defecation times were 74.3 ± 3.1 and 29.4 ± 4.1 h, respectively (P < 0.05). CONCLUSIONS Stomach volume-preserving Braun gastrointestinal bypass surgery was faster and produced hypoglycemic effects similar to RYGB bypass surgery, potentially minimizing metabolic disruption.
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Mata-Cases M, Benito-Badorrey B, Roura-Olmeda P, Franch-Nadal J, Pepió-Vilaubí JM, Saez M, Coll-de-Tuero G. Clinical inertia in the treatment of hyperglycemia in type 2 diabetes patients in primary care. Curr Med Res Opin 2013; 29:1495-502. [PMID: 23944631 DOI: 10.1185/03007995.2013.833089] [Citation(s) in RCA: 46] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
OBJECTIVE To assess clinical inertia, defined as failure to intensify antidiabetic treatment of patients who have not achieved the HbA1c therapeutic goal (≤7%). RESEARCH DESIGN AND METHODS Multicenter cross-sectional study. Clinical inertia was assessed in a random sample of type 2 diabetes mellitus (T2DM) patients seen in primary care centers. RESULTS A total of 2783 patients (51.3% males; mean age: 68 [±11.5] years; diabetes duration: 7.1 [±5.6] years; mean HbA1c: 6.8 [±1.5]) were analyzed. Of those, 997 (35.8%) had HbA1c >7%. Treatment was intensified in 66.8% and consisted of: dose increase (40.5%); addition of oral antidiabetic (45.8%); or insulin treatment initiation (3.7%). Mean HbA1c values in patients for whom treatment was intensified vs. non-intensified were 8.4% (±1.2) vs. 8.2% (±1.2), p < 0.05. Clinical inertia was detected in 33.2% of patients and diminished along with treatment complexity: lifestyle changes only (38.8%), oral monotherapy (40.3%), combined oral antidiabetics (34.5%), insulin monotherapy (26.1%) and combination of insulin and oral antidiabetics (21.4%). Clinical inertia decreased as HbA1c increased: 37.3% for HbA1c values ranging between 7.1%-8%; 29.4% for the 8.1%-9% HbA1c range and 27.1% for HbA1c ≥9%. Multivariate analysis confirmed that diabetes duration, step of treatment and HbA1c were related to inertia. For each unit of HbA1c increase clinical inertia decreased 47% (OR: 0.53). LIMITATIONS The retrospective design of the study precluded an accurate investigation about reasons for lack of intensification that could actually be justified by some patient conditions, especially patients' lack of adherence. CONCLUSIONS Clinical inertia affected one third of T2DM patients with poor glycemic control and was greater in patients treated with only lifestyle changes or oral monotherapy. Treatment changes were performed when mean HbA1c values were 1.4 points above therapeutic goals.
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Affiliation(s)
- Manel Mata-Cases
- Primary Care Center (PCC) La Mina, Sant Adrià de Besòs , Barcelona , Spain
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Mata-Cases M, Franch-Nadal J, Mauricio D, Bolíbar B. Investigar en diabetes desde una base de datos de atención primaria: la experiencia del Sistema de Información para el Desarrollo de la Investigación en Atención Primaria (SIDIAP). ACTA ACUST UNITED AC 2013. [DOI: 10.1016/j.avdiab.2013.09.002] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/18/2023]
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Mathieu C, Barnett AH, Brath H, Conget I, de Castro JJ, Göke R, Márquez Rodriguez E, Nilsson PM, Pagkalos E, Penfornis A, Schaper NC, Wangnoo SK, Kothny W, Bader G. Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: a real-life worldwide observational study (EDGE). Int J Clin Pract 2013; 67:947-56. [PMID: 23961850 PMCID: PMC4231206 DOI: 10.1111/ijcp.12252] [Citation(s) in RCA: 48] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/22/2013] [Accepted: 07/14/2013] [Indexed: 02/05/2023] Open
Abstract
AIM Real-life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add-on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real-life setting, and to explore the advantages and limitations of large-scale 'pragmatic' trials. METHODS EDGE was a prospective, 1-year, worldwide, real-life observational study in which 2957 physicians reported on the effects of second-line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end-point (PEP) evaluated proportions of patients decreasing HbA(1c) > 0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end-point (SEP 3) was attainment of end-point HbA(1c) < 7% without hypoglycaemia or ≥ 3% increase in body weight. RESULTS In this large group of T2DM patients, a second OAD was added at mean HbA(1c) of 8.2 ± 1.3%, with no baseline HbA(1c) difference between cohorts. Second-line OAD therapy attained the PEP in the majority of patients, with higher attainment in those prescribed a vildagliptin-based regimen. The adjusted odds ratio was 1.49 (95% CI: 1.42, 1.55; p < 0.001). In patients with baseline HbA(1c) ≥ 7%, SEP 3 was achieved by 35% of patients on a vildagliptin-based combination and by 23% of those receiving comparator combinations. The adjusted odds ratio was 1.96 (95% CI: 1.85, 2.07; p < 0.001). Safety events were reported infrequently and safety profiles of vildagliptin and other OADs were consistent with previous data. CONCLUSION EDGE demonstrates that in a 'real-life' setting, vildagliptin as second OAD can lower HbA(1c) to target without well-recognised OAD side effects, more frequently than comparator OADs. In addition, EDGE illustrates that conducting large-scale, prospective, real-life studies poses challenges but yields valuable clinical information complementary to RCTs.
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Affiliation(s)
- C Mathieu
- I.G. - Endocrinologie, Campus Gasthuisberg, Leuven, Belgium
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