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Lee-Riddle GS, Schmidt HJ, Reese PP, Nelson MN, Neergaard R, Barg FK, Serper M. Transplant recipient, care partner, and clinician perceptions of medication adherence monitoring technology: A mixed methods study. Am J Transplant 2024; 24:669-680. [PMID: 37923085 DOI: 10.1016/j.ajt.2023.10.030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/28/2023] [Revised: 10/28/2023] [Accepted: 10/30/2023] [Indexed: 11/07/2023]
Abstract
Medication nonadherence is a leading cause of graft loss. Adherence monitoring technologies-reminder texts, smart bottles, video-observed ingestion, and digestion-activated signaling pills-may support adherence. However, patient, care partner, and clinician perceptions of these tools are not well studied. We conducted qualitative individual semistructured interviews and focus groups among 97 participants at a single center: kidney and liver transplant recipients 2 weeks to 18 months posttransplant, their care partners, and transplant clinicians. We assessed adherence practices, reactions to monitoring technologies, and opportunities for care integration. One-size-fits-all approaches were deemed infeasible. Interviewees considered text messages the most acceptable approach; live video checks were the least acceptable and raised the most concerns for inconvenience and invasiveness. Digestion-activated signaling technology produced both excitement and apprehension. Patients and care partners generally aligned in perceptions of adherence monitoring integration into clinical care. Key themes were importance of routine, ease of use, leveraging technology for actionable medication changes, and aversion to surveillance. Transplant clinicians similarly considered text messages most acceptable and video checks least acceptable. Clinicians reported that early posttransplant use and real-time adherence tracking with patient feedback may facilitate successful implementation. The study provides initial insights that may inform future adherence technology implementation.
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Affiliation(s)
- Grace S Lee-Riddle
- Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Harald J Schmidt
- Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Peter P Reese
- Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Maria N Nelson
- Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Rebecca Neergaard
- Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Frances K Barg
- Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Marina Serper
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
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Dumortier J, Boillot O. Conversion from twice-daily everolimus to once-daily sirolimus in long-term stable liver transplant recipients. Transpl Immunol 2024; 83:102014. [PMID: 38395088 DOI: 10.1016/j.trim.2024.102014] [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: 01/10/2024] [Revised: 02/19/2024] [Accepted: 02/20/2024] [Indexed: 02/25/2024]
Abstract
BACKGROUND After organ transplantation, strategies for simplifying the therapeutic regimen may improve adherence and prevent acute organ rejection and/or late graft loss. The present study aimed to evaluate the safety and efficacy of conversion from everolimus (EVR) twice daily to sirolimus (SIR) once daily in a large cohort of liver transplantation (LT) patients. METHODS We included 108 LT patients with at least 12 months of post-transplant follow-up and no rejection episodes in the last year. Conversion was based on a 1:1 ratio (but eventually adapted to available formulations of SIR). RESULTS The median age at the time of conversion was 68.9 years (range: 26.1-83.6); 75.0% were men. The main indications for mTOR inhibitor use were renal failure (38.9%) and/or a history of malignancy (37.0%). Median conversion time after LT was 14.8 years (range: 2.3-31.5). The median dose of EVR and SIR (initially) was 1.50 mg/day (range: 0.5-4.5). The mean follow-up after conversion was 15.8±4.4 months. Median serum EVR/SIR trough levels before/after conversion were 3.85 ng/mL vs. 6.32 ng/mL (p < 0.05), i.e. a 1:1.64 ratio. At the end of follow-up after conversion, the median dose of SIR was 1.25 mg/day (range: 0.5-3.5), and the mean serum SIR trough level was 5.23 ng/mL; 9 patients (8.3%) had returned to EVR, because of side effects (mainly digestive), that resolved thereafter. No biopsy-proven acute rejection episode was observed. Finally, 87.1% of patients considered the conversion beneficial and the cost was reduced by 50.3%. CONCLUSION The results of our study indicate that conversion from once-daily EVR to once-daily SIR in stable LT patients is safe, but needs dose adaptations and careful monitoring.
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Affiliation(s)
- Jérôme Dumortier
- Department of Digestive Diseases, Edouard Herriot Hospital, and University of Lyon 1 Claude Bernard, Lyon, France.
| | - Olivier Boillot
- Department of Digestive Diseases, Edouard Herriot Hospital, and University of Lyon 1 Claude Bernard, Lyon, France
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Thomas K, Babajide O, Gichoya J, Newsome J. Disparities in Transplant Interventions. Tech Vasc Interv Radiol 2023; 26:100921. [PMID: 38123285 DOI: 10.1016/j.tvir.2023.100921] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2023]
Affiliation(s)
- Kaesha Thomas
- Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA
| | - Owosela Babajide
- Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA
| | - Judy Gichoya
- Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA.
| | - Janice Newsome
- Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA
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Serper M, Burdzy A, Schaubel DE, Mason R, Banerjee A, Goldberg DS, Martin EF, Mehta SJ, Russell LB, Cheung AC, Ladner DP, Yoshino Benavente J, Wolf MS. Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial. BMJ Open 2023; 13:e075172. [PMID: 37723108 PMCID: PMC10510935 DOI: 10.1136/bmjopen-2023-075172] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/28/2023] [Accepted: 08/25/2023] [Indexed: 09/20/2023] Open
Abstract
BACKGROUND AND AIMS Liver transplantation is a life-saving procedure for end-stage liver disease. However, post-transplant medication regimens are complex and non-adherence is common. Post-transplant medication non-adherence is associated with graft rejection, which can have long-term adverse consequences. Transplant centres are equipped with clinical staff that monitor patients post-transplant; however, digital health tools and proactive immunosuppression adherence monitoring has potential to improve outcomes. METHODS AND ANALYSIS This is a patient-randomised prospective clinical trial at three transplant centres in the Northeast, Midwest and South to investigate the effects of a remotely administered adherence programme compared with usual care. The programme monitors potential non-adherence largely levering text message prompts and phenotypes the nature of the non-adhere as cognitive, psychological, medical, social or economic. Additional reminders for medications, clinical appointments and routine self-management support are incorporated to promote adherence to the entire medical regimen. The primary study outcome is medication adherence via 24-hour recall; secondary outcomes include additional medication adherence (ASK-12 self-reported scale, regimen knowledge scales, tacrolimus values), quality of life, functional health status and clinical outcomes (eg, days hospitalised). Study implementation, acceptability, feasibility, costs and potential cost-effectiveness will also be evaluated. ETHICS AND DISSEMINATION The University of Pennsylvania Review Board has approved the study as the single IRB of record (protocol # 849575, V.1.4). Results will be published in peer-reviewed journals and summaries will be provided to study funders. TRIAL REGISTRATION NUMBER NCT05260268.
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Affiliation(s)
- Marina Serper
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Alexander Burdzy
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Douglas E Schaubel
- Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Richard Mason
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Arpita Banerjee
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - David S Goldberg
- Division of Digestive Health and Liver Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA
| | - Eric F Martin
- Division of Digestive Health and Liver Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA
| | - Shivan J Mehta
- Division of Gastroenterology and Hepatology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Louise B Russell
- Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Amanda C Cheung
- Division of Gastroenterology and Hepatology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
| | - Daniela P Ladner
- Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
| | - Julia Yoshino Benavente
- Center for Applied Health Research on Aging, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
| | - Michael S Wolf
- Center for Applied Health Research on Aging, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
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Vaisbourd Y, Dahhou M, Zhang X, Sapir-Pichhadze R, Cardinal H, Johnston O, Blydt-Hansen TD, Tibbles LA, Hamiwka L, Urschel S, Birk P, Bissonnette J, Matsuda-Abedini M, BScPhm JH, Schiff J, Phan V, De Geest S, Allen U, Avitzur Y, Mital S, Foster BJ. Differences in medication adherence by sex and organ type among adolescent and young adult solid organ transplant recipients. Pediatr Transplant 2023; 27:e14446. [PMID: 36478059 DOI: 10.1111/petr.14446] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/22/2022] [Revised: 10/26/2022] [Accepted: 11/11/2022] [Indexed: 12/12/2022]
Abstract
BACKGROUND Identification of differences in medication adherence by sex or organ type may help in planning interventions to optimize outcomes. We compared immunosuppressive medication adherence between males and females, and between kidney, liver and heart transplant recipients. METHODS This multicenter study of prevalent kidney, liver and heart transplant recipients 14-25 years assessed adherence 3 times (0, 3, 6 months post-enrollment) with the BAASIS self-report tool. At each visit, participants were classified as adherent if they missed no doses in the prior 4 weeks and non-adherent otherwise. Adherence was also assessed using the coefficient of variation (CV) of tacrolimus trough levels; CV < 30% was classified as adherent. We used multivariable mixed effects logistic regression models adjusted for potential confounders to compare adherence by sex and by organ. RESULTS Across all visits, males (n = 150, median age 20.4 years, IQR 17.2-23.3) had lower odds of self-reported adherence than females (n = 120, median age 19.8 years, IQR 17.1-22.7) (OR 0.41, 95% CI 0.21-0.80) but higher odds of adherence by tacrolimus CV (OR 2.50, 95% CI 1.30-4.82). No significant differences in adherence (by self-report or tacrolimus CV) were noted between the 184 kidney, 58 liver, and 28 heart recipients. CONCLUSION Females show better self-reported adherence than males but greater variability in tacrolimus levels. Social desirability bias, more common in females than males, may contribute to better self-reported adherence among females. Higher tacrolimus variability among females may reflect biologic differences in tacrolimus metabolism between males and females rather than sex differences in adherence. There were no significant differences in adherence by organ type.
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Affiliation(s)
| | - Mourad Dahhou
- Research Institute of The McGill University Health Centre, Quebec, Canada
| | - Xun Zhang
- Research Institute of The McGill University Health Centre, Quebec, Canada
| | - Ruth Sapir-Pichhadze
- Research Institute of The McGill University Health Centre, Quebec, Canada.,Department of Medicine, McGill University, Quebec, Canada.,Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Quebec, Canada
| | | | - Olwyn Johnston
- Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
| | - Tom D Blydt-Hansen
- Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada
| | - Lee Anne Tibbles
- Department of Medicine and Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Lorraine Hamiwka
- Department of Paediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Simon Urschel
- Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada
| | - Patricia Birk
- Section of Pediatric Nephrology, University of Manitoba, Winnipeg, Manitoba, Canada
| | | | - Mina Matsuda-Abedini
- Department of Pediatrics, The Hospital for Sick Children and The University of Toronto, Toronto, Ontario, Canada
| | - Jennifer Harrison BScPhm
- Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.,Ajmera Transplant Centre, Toronto General Hospital, Toronto, Ontario, Canada
| | - Jeffrey Schiff
- Ajmera Transplant Centre, Toronto General Hospital, Toronto, Ontario, Canada
| | | | - Sabina De Geest
- Department Public Health, Institute of Nursing Science, University of Basel, Basel, Switzerland.,Department of Primary Care and Public Health, Academic Center of Nursing and Midwifery, KU Leuven, Leuven, Belgium
| | - Upton Allen
- Department of Pediatrics, The Hospital for Sick Children and The University of Toronto, Toronto, Ontario, Canada
| | - Yaron Avitzur
- Department of Pediatrics, The Hospital for Sick Children and The University of Toronto, Toronto, Ontario, Canada
| | - Seema Mital
- Department of Pediatrics, The Hospital for Sick Children and The University of Toronto, Toronto, Ontario, Canada
| | - Bethany J Foster
- Department of Pediatrics, McGill University, Quebec, Canada.,Research Institute of The McGill University Health Centre, Quebec, Canada.,Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Quebec, Canada
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6
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Karthikeyan B, Sharma RK, Mehrotra S, Gupta A, Kaul A, Bhaudauria DS, Prasad N. Comparative Analysis of Determinants and Outcome of Early and Late Acute Antibody Mediated Rejection (ABMR). Indian J Nephrol 2023; 33:22-27. [PMID: 37197045 PMCID: PMC10185016 DOI: 10.4103/ijn.ijn_375_20] [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: 08/01/2020] [Revised: 09/26/2020] [Accepted: 10/10/2021] [Indexed: 12/29/2022] Open
Abstract
Introduction Antibody-mediated rejection (ABMR) is one of the major determinants of graft survival. Although diagnostic precision and treatment options have improved, response to therapy and graft survival has not improved very significantly. The phenotypes of early and late acute ABMR differ in many ways. In this study, we assessed the clinical characteristics, response to therapy, DSA positivity, and outcomes of early and late ABMR. Methods During the study period, 69 patients with acute ABMR diagnosed on renal graft histopathology were included with a median follow-up of 10 months after rejection. Recipients were stratified into early acute ABMR (<3 months of transplant; n = 29) and late acute ABMR (>3 months of transplant; n = 40). Graft survival, patient survival, response to therapy, and doubling of serum creatinine were assessed and compared between the two groups. Results Baseline characteristics and immunosuppression protocols were comparable between the early and late ABMR groups. Late acute ABMR had an increased risk of doubling of serum creatinine than the early ABMR group (P = 0.002). Graft and patient survival were not statistically different between the two groups. Response to therapy was inferior in the late acute ABMR group (P = 0.00). Pretransplant DSA was present in 27.6% in the early ABMR group. Late acute ABMR was frequently associated with nonadherence or suboptimal immunosuppression and low DSA positivity (15%). Infections such as CMV, bacterial, and fungal infections were similar in the earlier and late ABMR groups. Conclusion Late acute ABMR group had a poor response to anti-rejection therapy and also an increased risk of doubling of serum creatinine compared to the early acute ABMR group. There was also a tendency toward increased graft loss in late acute ABMR patients. Late acute ABMR patients are more frequently associated with nonadherence/suboptimal immunosuppression. There was also a low incidence of anti-HLA DSA positivity in late ABMR.
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Affiliation(s)
- Balasubramanian Karthikeyan
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
| | - Raj K. Sharma
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
| | - Sonia Mehrotra
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
| | - Amit Gupta
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
| | - Anupama Kaul
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
| | - Dharmendra S. Bhaudauria
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
| | - Narayan Prasad
- Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
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Hammond C, Hussaini T, Yoshida EM. Medical adherence and liver transplantation: a brief review. CANADIAN LIVER JOURNAL 2021; 4:8-15. [PMID: 35991471 PMCID: PMC9203162 DOI: 10.3138/canlivj-2020-0016] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2020] [Accepted: 06/16/2020] [Indexed: 11/13/2023]
Abstract
Liver transplantation remains the only feasible long-term treatment option for patients with end-stage liver disease. Despite significant medical and surgical advances over the decades, liver transplantation remains a complex undertaking with the need for indefinite immunosuppression and avoidance of patient behaviours that may jeopardize the allograft. Adherence (formerly called "compliance") to medical recommendations in terms of anti-rejection medications and-in the case of alcoholic liver disease, abstinence-is considered a key cornerstone to long-term allograft and patient survival. Not surprisingly, a history of habitual non-adherence is considered a contraindication to liver transplantation, especially re-transplantation. It is often assumed that non-adherence policies are "self-evidential" based on "common sense" and "expert opinion." In fact, non-adherence and its negative effects have been well studied in medicine, including in solid organ transplantation. In this review, we present the evidence that non-adherence to medical advice is clearly associated with worse medical outcomes, supporting the concept that efforts to support patient adherence post-transplant need to be optimized at all times.
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Affiliation(s)
- Carl Hammond
- Department of Gastroenterology, University Hospital Coventry & Warwickshire, United Kingdom
| | - Trana Hussaini
- Department of Pharmacy, Vancouver General Hospital, Vancouver, British Columbia, Canada
| | - Eric M Yoshida
- Division of Gastroenterology, the University of British Columbia, Vancouver, British Columbia, Canada
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8
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Lenain R, Dantan E, Giral M, Foucher Y, Asar Ö, Naesens M, Hazzan M, Fournier MC. External Validation of the DynPG for Kidney Transplant Recipients. Transplantation 2021; 105:396-403. [PMID: 32108750 DOI: 10.1097/tp.0000000000003209] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
BACKGROUND In kidney transplantation, dynamic prediction of patient and kidney graft survival (DynPG) may help to promote therapeutic alliance by delivering personalized evidence-based information about long-term graft survival for kidney transplant recipients. The objective of the current study is to externally validate the DynPG. METHODS Based on 6 baseline variables, the DynPG can be updated with any new serum creatinine measure available during the follow-up. From an external validation sample of 1637 kidney recipients with a functioning graft at 1-year posttransplantation from 2 European transplantation centers, we assessed the prognostic performance of the DynPG. RESULTS As one can expect from an external validation sample, differences in several recipient, donor, and transplantation characteristics compared with the learning sample were observed. Patients were mainly transplanted from deceased donors (91.6% versus 84.8%; P < 0.01), were less immunized against HLA class I (18.4% versus 32.7%; P < 0.01) and presented less comorbidities (62.2% for hypertension versus 82.7%, P < 0.01; 25.1% for cardiovascular disease versus 33.9%, P < 0.01). Despite these noteworthy differences, the area under the ROC curve varied from 0.70 (95% confidence interval [CI], 0.64-0.76) to 0.76 (95% CI, 0.64-0.88) for prediction times at 1 and 6 years posttransplantation respectively, and calibration plots revealed reasonably accurate predictions. CONCLUSIONS We validated the prognostic capacities of the DynPG in terms of both discrimination and calibration. Our study showed the robustness of the DynPG for informing both the patient and the physician, and its transportability for a cohort presenting different features than the one used for the DynPG development.
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Affiliation(s)
- Rémi Lenain
- Department of Nephrology, Huriez Hospital, Lille University Hospital, Lille, France
| | - Etienne Dantan
- INSERM UMR 1246 - SPHERE, Nantes University, Tours University, Nantes, France
| | - Magali Giral
- CRTI UMR 1064, Inserm, Université de Nantes, ITUN, CHU Nantes, RTRS Centaure, Nantes, France
- Centre d'Investigation Clinique en Biothérapie, Nantes, France
| | - Yohann Foucher
- INSERM UMR 1246 - SPHERE, Nantes University, Tours University, Nantes, France
- Centre Hospitalier Universitaire de Nantes, Nantes, France
| | - Özgür Asar
- Department of Biostatistics and Medical Informatics, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey
| | - Maarten Naesens
- Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium
- Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium
| | - Marc Hazzan
- Department of Nephrology, Huriez Hospital, Lille University Hospital, Lille, France
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9
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Jones LS, Serper M. Medication non-adherence among liver transplant recipients. CURRENT HEPATOLOGY REPORTS 2020; 19:327-336. [PMID: 33816051 PMCID: PMC8011544 DOI: 10.1007/s11901-020-00545-7] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 10/07/2020] [Indexed: 01/30/2023]
Abstract
PURPOSE OF REVIEW We provide an overview of the recent evidence on the prevalence, risk factors, and consequences of medication non-adherence (NA) in liver transplant (LT) recipients. RECENT FINDINGS NA in LT is associated with socio-demographic and medication-related factors, low social support, and poor health literacy. Patient-reported adherence is one of the most common methods to measure NA using validated assessments; immunosuppression (IS) drug levels and electronic monitoring may also be used. Simplification of IS regimens such as the conversion from twice daily to once daily has been shown to be safe, effective, and improves adherence. Relatively few studies have prospectively investigated NA predictors or interventions to reduce NA in LT. SUMMARY Medication non-adherence is a multi-faceted issue that is common among LT recipients and associated with adverse outcomes. NA in LT recipients warrants further study as only a few interventions have been published focused on reducing NA in LT.
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Affiliation(s)
- Lauren S. Jones
- Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine
- Philadelphia College of Osteopathic Medicine, Philadelphia, PA
| | - Marina Serper
- Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine
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10
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Guldager TB, Hyldgaard C, Hilberg O, Bendstrup E. An E-Learning Program Improves Patients' Knowledge After Lung Transplantation. Telemed J E Health 2020; 27:800-806. [PMID: 33035148 DOI: 10.1089/tmj.2020.0101] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/16/2023] Open
Abstract
Background: Adherence to immunosuppressive medicine in lung transplant recipients is associated with improved long-term survival. Patient education and support from health care providers are key components. We investigated e-learning as a tool to improve lung transplant recipients' knowledge of post-transplant care such as hygiene, self-monitoring, travel precautions, vaccinations, and the importance of adherence to medication. Objective: To compare the effect of e-learning and conventional patient education with respect to level of knowledge and drug adherence. A single-center open randomized controlled trial design was used. Methods: Lung transplant recipients were randomized to an e-learning program or standard care. One month before a scheduled follow-up visit, the intervention group received a link by e-mail to a 15-min e-learning program. At the follow-up visit, all lung transplant recipients completed two drug adherence questionnaires (Basel Assessment of Adherence with Immunosuppressive medication Scales [BAASIS] and Transplant Adherence Questionnaire [TAQ]) and a questionnaire testing their knowledge of post-transplant care. Results: Fifty lung transplant recipients were randomized with 24 recipients in each group completing the study. Recipient adherence measured by BAASIS showed a tendency toward improved drug adherence in the intervention group compared with the control group (71% vs. 55%, p = 0.23). TAQ showed no difference between the two groups (p = 1.0). Recipients in the intervention group had a significantly higher number of correct answers to questions about transplant-friendly lifestyle (median 11 vs. 10, p = 0.02). Conclusion: A 15-min e-learning program is a simple and effective tool to improve lung transplant recipients' knowledge of post-transplant care.
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Affiliation(s)
- Tina Beck Guldager
- Department of Respiratory Diseases and Allergy, Arhus University Hospital, Aarhus N, Denmark
| | - Charlotte Hyldgaard
- Diagnostic Centre, University Research Clinic for innovative Patient Pathways, Silkeborg Regional Hospital, Midtjylland, Denmark
| | - Ole Hilberg
- Department of Internal Medicine, Lillebaelt Hospital, Vejle, Denmark
| | - Elisabeth Bendstrup
- Department of Respiratory Diseases and Allergy, Arhus University Hospital, Aarhus N, Denmark
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11
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Belaiche S, Décaudin B, Caron A, Depas N, Vignaux C, Vigouroux S, Coiteux V, Magro L, Sirvent A, Huynh A, Turlure P, Farge D, Lioure B, Bruno B, De Berranger E, Maillard N, Bourhis JH, Bay JO, Bulabois CE, Ceballos P, Fegueux N, Hicheri Y, Vincent L, Rialland F, Gandemer V, Taque S, Cornillon J, Contentin N, Galambrun C, Plantaz D, Odou P, Yakoub-Agha I. Medication non-adherence after allogeneic hematopoietic cell transplantation in adult and pediatric recipients: a cross sectional study conducted by the Francophone Society of Bone Marrow Transplantation and Cellular Therapy. Fundam Clin Pharmacol 2020; 35:435-445. [PMID: 32740936 DOI: 10.1111/fcp.12593] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/10/2019] [Revised: 06/09/2020] [Accepted: 07/27/2020] [Indexed: 12/14/2022]
Abstract
Medication non-adherence (NA) after allogeneic hematopoietic cell transplantation (allo-HCT) can lead to serious complications. This study assesses NA in French adult and pediatric recipients and identifies factors associated with NA. In accordance with the EMERGE and STROBE guidelines, a cross sectional multicentric survey was conducted. We used a self-reported questionnaire that was adapted to adults and pediatrics and that could provide a picture of all three phases of medication adherence: initiation, implementation, persistence. We enrolled 242 patients, 203 adults (mean age: 51 years old, 50.7% male) and 39 children (mean age: 9 years old, 56.4% female). Reported NA was estimated at about 75% in both populations, adults and pediatrics. In adults, the univariate analysis showed that patients less than 50 years old (P = 0.041), (i) treated with cyclosporine (P = 0.02), (ii) treated with valacyclovir/acyclovir (P = 0.016), and (iii) experiencing side effects (P = 0.009), were significantly more non-adherent. In multivariate analysis, only recipient age was significantly associated to NA (P = 0.05). The limited size of the pediatric population did not allow us to draw any statistical conclusion about this population. To the best of our knowledge, this is the first study in France on NA in allo-HCT recipients. Our results highlight the age factor as the only factor related to NA. Further studies are needed to confirm our observations and refine results in pediatric populations, currently most at risk of medication NA.
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Affiliation(s)
| | | | - Alexandre Caron
- EA 2694 - Santé publique: épidémiologie et qualité des soins, CHU Lille, Univ. Lille, Lille, F-59000, France
| | - Nicolas Depas
- EA 2694 - Santé publique: épidémiologie et qualité des soins, CHU Lille, Univ. Lille, Lille, F-59000, France
| | - Claire Vignaux
- Service Hématologie Adulte, CHU Bordeaux, Bordeaux Cedex, F-33076, France
| | - Stephane Vigouroux
- Service Hématologie Adulte, CHU Bordeaux, Bordeaux Cedex, F-33076, France
| | | | | | - Anne Sirvent
- Service Hématologie Pédiatrique, CHU Montpellier, Montpellier, F-34090, France
| | - Anne Huynh
- Institut Universitaire du Cancer Toulouse - Oncopole, Toulouse Cedex 9, F-31059, France
| | - Pascal Turlure
- Service Hématologie Adulte, CHU Dupuytren, Limoges Cedex, F-87042, France
| | - Dominique Farge
- Service Hématologie Adulte, APHP- Hopital Saint Louis, Paris, F-75010, France
| | - Bruno Lioure
- Service Hématologie Adulte, Hopital de Hautepierre, CHU de Strasbourg, Strasbourg, F-67200, France
| | - Bénédicte Bruno
- Service Hématologie Pédiatrique, CHU Lille, Lille, F-59000, France
| | - Eva De Berranger
- Service Hématologie Pédiatrique, CHU Lille, Lille, F-59000, France
| | - Natacha Maillard
- Service Hématologie Adulte, CHU Poitier, Poitier, F-86000, France
| | - Jean-Henri Bourhis
- Service Hématologie Adulte, Institut Gustave Roussy, Villejuif Cedex, F-94805, France
| | | | | | - Patrice Ceballos
- Service Hématologie Adulte, CHU Montpellier, Montpellier, F-34090, France
| | - Nathalie Fegueux
- Service Hématologie Adulte, CHU Montpellier, Montpellier, F-34090, France
| | - Yosr Hicheri
- Service Hématologie Adulte, CHU Montpellier, Montpellier, F-34090, France
| | - Laure Vincent
- Service Hématologie Adulte, CHU Montpellier, Montpellier, F-34090, France
| | - Fanny Rialland
- Service Hématologie Pédiatrique, CHU Nantes, Nantes, F-44000, France
| | - Virginie Gandemer
- Service Hématologie Pédiatrique, CHU Rennes, Rennes Cedex 9, F-35033, France
| | - Sophie Taque
- Service Hématologie Pédiatrique, CHU Rennes, Rennes Cedex 9, F-35033, France
| | - Jérôme Cornillon
- Service Hématologie Adulte, Institut de Cancérologie Lucien Neuwirth, Saint Etienne, F-42000, France
| | - Nathalie Contentin
- Service Hématologie Adulte, Centre Henri Becquerel, Rouen Cedex, F 76038, France
| | - Claire Galambrun
- Service Hématologie Pédiatrique, APHM Hopital La Timone, Marseille, F-13005, France
| | - Dominique Plantaz
- Service Hématologie Pédiatrique, CHU Grenoble, La Tronche, F-38700, France
| | - Pascal Odou
- Institut de Pharmacie, CHU Lille, Lille, F-59000, France
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Terranella SL, Poirier J, Chan EY, Hertl M, Olaitan OK. Should Pre-Transplant Hemoglobin A1c Be Used to Predict Post-Transplant Compliance in End-Stage Renal Disease Patients Undergoing Kidney Transplantation? Ann Transplant 2020; 25:e924061. [PMID: 32587234 PMCID: PMC7339972 DOI: 10.12659/aot.924061] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/09/2022] Open
Abstract
Background Patient compliance with immunosuppressive therapy after transplant has impacts on both graft and patient outcomes. For diabetic end-stage renal disease (ESRD) patients who are undergoing evaluation for kidney transplantation in our program, hemoglobin A1c (HbA1c) level of >10% is used as a flag that the patient may be at risk for noncompliance and that more comprehensive psychosocial screening is needed prior to transplant. We evaluated the association between pre-transplant HbA1c level and post-transplant compliance, as no study to date has looked at this in the transplant population. Material/Methods The charts of 392 patients who received a kidney transplant at a single institution between July 2008 and June 2012 were retrospectively reviewed. One hundred and sixty-five diabetic patients who received a kidney transplant alone were included in the final analysis. Our predictive variable was HbA1c level greater than 7.7% based on previous reports in the diabetic population. Outcome measures were graft survival, rejection episodes, unexplained low immunosuppressant levels, and documented noncompliance. Results There were no statistically significant differences between the HbA1c groups of ≤7.7% and >7.7% in outcomes of failed grafts (22.0% and 17.8%, p=0.2), rejection episodes (15.0% and 6.7%, p=0.3), unexplained low immunosuppressant level (46.6% and 37.9%, p=0.3), and documented noncompliance (25.0% and 16.7%, p=0.4). Conclusions In diabetic ESRD patients selected for renal transplantation, elevated pre-transplant HbA1c levels, defined as HbA1c >7.7%, are not predictive of post-transplant medication compliance. We advocate that this group of patients should not be denied transplant solely on their elevated pre-transplant HbA1c.
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Affiliation(s)
| | - Jennifer Poirier
- Department of Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Edie Y Chan
- Department of Surgery, Rush University Medical Center, Chicago, IL, USA
| | - Martin Hertl
- Department of Surgery, Rush University Medical Center, Chicago, IL, USA
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Villeneuve C, Rousseau A, Rerolle JP, Couzi L, Kamar N, Essig M, Etienne I, Westeel PF, Büchler M, Esposito L, Thierry A, Marquet P, Monchaud C. Adherence profiles in kidney transplant patients: Causes and consequences. PATIENT EDUCATION AND COUNSELING 2020; 103:189-198. [PMID: 31447197 DOI: 10.1016/j.pec.2019.08.002] [Citation(s) in RCA: 27] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/14/2018] [Revised: 07/30/2019] [Accepted: 08/01/2019] [Indexed: 06/10/2023]
Abstract
OBJECTIVE Adherence is a dynamic phenomenon and a critical determinant of transplant patients outcome. The objective of this longitudinal study was to explore adherence in kidney transplant patients followed-up for up to three years after transplantation. METHODS Adherence was repeatedly estimated using the Morisky-Green-Levine 4-Item Medication Adherence Scale, in two successive cohorts of 345 (EPIGREN) and 367 (EPHEGREN) kidney transplant recipients. Mixed effect modeling with latent processes and latent classes was used to describe adherence time-profiles. RESULTS Two latent classes were identified. The adherent class represented 85% of the patients. Patients of the poorer-adherence class displayed a lower adherence at one month (p<10-3), which worsened over time. Good adherence was associated with age >50 years, fewer depression episodes (5% vs. 13%, p = 0.001) and a better mental health component of quality of life (MCS-SF36 47 ± 11 vs. 41 ± 13, p = 0.015). Survival without acute rejection episodes was longer in the adherent class (p = 0.004). CONCLUSIONS The risk of poor adherence in renal transplant patients can be detected as early as one month post-transplantation, using appropriate and easy tools adapted to routine monitoring. PRACTICE IMPLICATIONS An early focus on vulnerable patients should allow putting into place actions in order to reduce the risk of poor outcome related to poor adherence.
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Affiliation(s)
- Claire Villeneuve
- CHU Limoges, Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, F-87000 Limoges, France; INSERM, UMR-1248, F-87000 Limoges, France.
| | - Annick Rousseau
- INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Univ Limoges, Faculty of Pharmacy, Department of Biophysics, F-87000 Limoges, France
| | - Jean-Phillipe Rerolle
- INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Department of Nephrology, Dialysis and Transplantation, F-87000, Limoges, France
| | - Lionel Couzi
- Department of Nephrology, Transplantation, Dialysis, Centre Hospitalier Universitaire (CHU) Pellegrin, Bordeaux, France; CNRS-UMR 5164 Immuno ConcEpT, Bordeaux University, Bordeaux, France
| | - Nassim Kamar
- Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France; Université Paul Sabatier, Toulouse, France; INSERM U1043, IFR-BMT, CHU Purpan, Toulouse, France
| | - Marie Essig
- INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Department of Nephrology, Dialysis and Transplantation, F-87000, Limoges, France; Univ Limoges, Faculty of Medicine, F-87000 Limoges, France
| | - Isabelle Etienne
- Service de Nephrologie, Rouen University Hospital, Rouen, France
| | - Pierre-Francois Westeel
- Department of Nephrology and Kidney Transplantation, University Hospital of Amiens, Amiens, France
| | - Mathias Büchler
- FHU SUPORT, Limoges, F-87000, France; Department of Nephrology and Kidney Transplantation, University Hospital of Tours, Tours, France; François Rabelais University, EA 4245 Tours, France
| | - Laure Esposito
- Department of Nephrology and Organ Transplantation, CHU Toulouse, Toulouse, France
| | - Antoine Thierry
- FHU SUPORT, Limoges, F-87000, France; CHU Poitiers, Department of Nephrology, Dialysis and Transplantation, F-86000 Poitiers, France
| | - Pierre Marquet
- CHU Limoges, Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, F-87000 Limoges, France; INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France; Univ Limoges, Faculty of Medicine, F-87000 Limoges, France
| | - Caroline Monchaud
- CHU Limoges, Department of Pharmacology, Toxicology and Centre of Pharmacovigilance, F-87000 Limoges, France; INSERM, UMR-1248, F-87000 Limoges, France; FHU SUPORT, Limoges, F-87000, France
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14
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Web-Based Tailored Nursing Intervention to Support Medication Self-management. ACTA ACUST UNITED AC 2019; 37:564-572. [DOI: 10.1097/cin.0000000000000572] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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15
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Gokoel SRM, Gombert-Handoko KB, Zwart TC, van der Boog PJM, Moes DJAR, de Fijter JW. Medication non-adherence after kidney transplantation: A critical appraisal and systematic review. Transplant Rev (Orlando) 2019; 34:100511. [PMID: 31627978 DOI: 10.1016/j.trre.2019.100511] [Citation(s) in RCA: 53] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2019] [Revised: 08/27/2019] [Accepted: 08/28/2019] [Indexed: 10/26/2022]
Abstract
Medication non-adherence is one of the most important causes for shortened graft survival subsequently leading to a reduction in kidney graft survival results. Our aim was to provide an overview of its prevalence, risk factors, diagnostic methods and interventions to improve adherence in kidney transplant recipients. Therefore, we systematically searched the databases PubMed, COCHRANE Library, Web of Science and EMBASE for studies addressing "medication adherence", "compliance", "adherence", "kidney transplantation" and "life style factors". We identified 96 studies that satisfied our inclusion criteria. A problematic lack of a uniformly accepted definition for non-adherence was found, consequently leading to a wide range in non-adherence prevalence (36-55%). Using one uniformly accepted non-adherence definition should therefore be encouraged. A wide range in diagnostic methods makes it difficult to accurately detect non-adherence. Heterogeneous results of intervention studies make it difficult to select the best adherence enhancing method, challenging the battle against medication non-adherence. Literature suggests a combination of personalized interventions, based on patient-specific non-adherent behavior, to be most successful in improvement of adherence. High quality diagnostic methods and multidisciplinary, personalized interventions with focus on relevant clinical outcome are essential in overcoming medication non-adherence in kidney transplant recipients.
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Affiliation(s)
- Sumit R M Gokoel
- Division of Nephrology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands.
| | - Kim B Gombert-Handoko
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands
| | - Tom C Zwart
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands
| | - Paul J M van der Boog
- Division of Nephrology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands
| | - Dirk Jan A R Moes
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, the Netherlands
| | - Johan W de Fijter
- Division of Nephrology, Department of Medicine, Leiden University Medical Center, Leiden, the Netherlands
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16
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Bakr MA, Nagib AM, Abbas MH, Donia AF. Conversion From Twice-Daily to Once-Daily Tacrolimus Among Egyptian Living-Donor Kidney Allograft Recipients: A Single-Center Experience. EXP CLIN TRANSPLANT 2019; 17:594-598. [PMID: 31050617 DOI: 10.6002/ect.2018.0147] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
OBJECTIVES Adherence to immunosuppression and minimization of drug exposure are important con-siderations in preventing rejection and maximizing transplant outcomes. The once-daily tacrolimus protocol confers potential benefit by simplifying immunosuppressive regimens, thereby improving adherence among transplant recipients. Studies of stable transplant recipients have suggested that once-daily tacrolimus is bioequivalent to twice-daily tacrolimus and is noninferior to twice-daily tacrolimus with a concentration-dependent rejection risk. Our aim was to evaluate the safety and efficacy of conversion from twice-daily tacrolimus formulation to a once-daily formulation among a cohort of adult living related-donor renal transplant patients as a single-center experience. MATERIALS AND METHODS This prospective, one arm, single-center study included 238 patients with at least 12 months posttransplant follow-up and no rejection episodes in the last 3 months. Conversion from twice-daily to once-daily formulation was based on a 1:1 ratio. RESULTS The mean tacrolimus dose was 4.7 ± 2.7 mg/day preconversion versus 4.9 ± 3.2 mg/day postconversion (P = .8). The mean tacrolimus level was 7.4 ± 3.4 versus 6.1 ± 2.8 ng/mL (P = .75). Of total patients, 45% were maintained on a tacrolimus dose of less than 2 ng/dL. Renal function was comparable before and after conversion (mean serum creatinine was 1.25 ± 0.88 vs 1.23 ± 0.78 mg/dL; P = .9). The incidence of biopsy-proven acute rejection was 19.7% preconversion versus 4.2% postconversion. Graft and patient survival rates were comparable between the 2 tacrolimus formulations. Once-daily tacrolimus also had favorable effects on blood pressure, lipid profile, and glucose tolerance. CONCLUSIONS Conversion from conventional tacrolimus (twice daily) to once-daily tacrolimus may be a valuable option with comparable patient and graft survival and may lead to improved adherence that may be reflective of better long-term results. It should be considered for de novo immunosuppression among living-donor renal allotransplant recipients.
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Affiliation(s)
- Mohamed Adel Bakr
- From the Department of Dialysis and Transplantation, The Urology-Nephrology Center, Mansoura University, Mansoura, Egypt
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Sitruk L, Couchoud C, Hourmant M, Tuppin P, Macher MA, Legeai C. [Description of immunosuppressive maintenance treatments post kidney transplant through the National System of Health Insurance]. Nephrol Ther 2018; 14:523-530. [PMID: 29887268 DOI: 10.1016/j.nephro.2018.03.004] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2017] [Revised: 03/02/2018] [Accepted: 03/18/2018] [Indexed: 01/08/2023]
Abstract
The aim of this study was to describe the drug dispensing of maintenance immunosuppression treatment in 2014 for patients who received a kidney transplant in 2012, based on the data of the French national health insurance and to compare those results with the information collected in the national database for kidney recipients. For each patient, are considered all drugs dispensing with their dates of issue, the molecules and their presentations (number of pills and dosage). Among 2463 transplanted adults in 2012, 73% have received tacrolimus monohydrate, 59% mycophenolate mofetil, 54% prednisone and 20% cyclosporin in 2014. The daily doses but not the number of tablets per day declined with age. The most frequent association was tacrolimus monohydrate-mycophenolate mofetil-steroids in 34% of the cases. The use of mTOR inhibitors, rare generally (7%), is more common in patients aged 66-85 years. Associations did not differ significantly according to diabetic status, for patients with a kidney from an elderly donor or according to the number of mismatch. The daily doses estimated from the deliverance in pharmacy are respectively similar, understated and over-estimate for tacrolimus, mycophenolate mofetil and cyclosporin compared to the national database. This study confirms the difficulty of apprehending drug consumption based only on dispensing in pharmacies or punctual recording even if it allows a fairly comprehensive view of French practices.
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Affiliation(s)
- Lola Sitruk
- Agence de la biomédecine, 1, avenue du Stade-de-France, 93212 Saint-Denis-La-Plaine cedex, France
| | - Cécile Couchoud
- Agence de la biomédecine, 1, avenue du Stade-de-France, 93212 Saint-Denis-La-Plaine cedex, France
| | - Maryvonne Hourmant
- Service de néphrologie et d'immunologie clinique, CHU, 30, boulevard Jean-Monnet, immeuble Jean-Monnet, 44093 Nantes cedex 1, France
| | - Philippe Tuppin
- Caisse nationale de l'Assurance maladie des travailleurs salariés, Direction de la stratégie des études et des statistiques, 26-50, avenue du Professeur-André-Lemierre, 75986 Paris cedex 20, France
| | - Marie-Alice Macher
- Agence de la biomédecine, 1, avenue du Stade-de-France, 93212 Saint-Denis-La-Plaine cedex, France
| | - Camille Legeai
- Agence de la biomédecine, 1, avenue du Stade-de-France, 93212 Saint-Denis-La-Plaine cedex, France.
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18
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Moayed MS, Ebadi A, Khodaveisi M, Nassiri Toosi M, Soltanian AR, Khatiban M. Factors influencing health self-management in adherence to care and treatment among the recipients of liver transplantation. Patient Prefer Adherence 2018; 12:2425-2436. [PMID: 30510406 PMCID: PMC6248226 DOI: 10.2147/ppa.s180341] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/04/2023] Open
Abstract
INTRODUCTION Liver transplantation is the global treatment of end-stage liver diseases. Since the patients' survival rate has been improved, the patient may experience reductions in physical, cognitive, and psychosocial functions after liver transplantation influencing their adherence to care and treatment. The transplant survival is complex and patients' adherence to care and treatment should be considered when health care providers make decisions regarding treatment. This qualitative study aimed to explore factors influencing health self-management in adherence to care and treatment among the recipients of care and treatment. METHODS In this study, 23 interview sessions were carried out with a total 18 patients, 2 family members and 3 transplantation team members from May to November 2017. The patients were selected using the purposive method from both genders, with a various age range and initial diseases leading to liver transplantation, and time passed from liver transplantation. A semi-structured interview guide was developed based on literature review and pilot interviews. The participants were asked to describe their experiences of self-management behaviors in adherence to treatment and care. The data were analyzed using a conventional content analysis method and managing via the MAXQDA-10 software. RESULTS Two themes were developed during data analysis as "self-regulation" and "self-care". "Self-regulation" consisted of "intentionally changing", "positively thinking", "information seeking", "problem-solving", "past knowledge transferring", and "self-controlling". "Self-care" had three sub-themes "shift to independence", "vigilance", and "self-care support". CONCLUSION The participants perceived the health self-management in adherence to care as a set of factors related to "self-regulation" and "self-care" behaviors. "Self-regulation" is required to create a balance in life. Also, "self-care" efforts can help with maintaining and improving patients' health.
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Affiliation(s)
- Malihe Sadat Moayed
- Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran
| | - Abbas Ebadi
- Nursing Education, Behavioral Sciences Research Center, Life Style Institute, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran
| | - Masoud Khodaveisi
- Chronic Diseases (Home Care) Research Center, Community Health Nursing Department, Hamadan University of Medical Sciences, Hamadan, Iran
| | - Mohssen Nassiri Toosi
- Internal Medicine, Hepatologist, Liver Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran
| | - Ali Reza Soltanian
- Modeling of Noncommunicable Diseases Research Center, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran
| | - Mahnaz Khatiban
- Mother and Child Care Research Center, Medical-Surgical Nursing Department, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran,
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Belaiche S, Décaudin B, Dharancy S, Gautier S, Noel C, Odou P, Hazzan M. Factors associated with the variability of calcineurin inhibitor blood levels in kidney recipients grafted for more than 1 year. Fundam Clin Pharmacol 2017; 32:88-97. [DOI: 10.1111/fcp.12328] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2017] [Revised: 09/06/2017] [Accepted: 10/10/2017] [Indexed: 11/30/2022]
Affiliation(s)
- Stéphanie Belaiche
- Institut de pharmacie; CHU Lille; F-59000 Lille France
- EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées; Université Lille; F-59000 Lille France
| | - Bertrand Décaudin
- Institut de pharmacie; CHU Lille; F-59000 Lille France
- EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées; Université Lille; F-59000 Lille France
| | - Sébastien Dharancy
- Service des Maladies de l'appareil Digestif et de la Nutrition; CHU Lille; F-59000 Lille France
- Inserm U995 - LIRIC - Lille Inflammation Research International Center; Université Lille; F-59000 Lille France
| | - Sophie Gautier
- Département de pharmacologie; CHU Lille; F-59000 Lille France
- Inserm, U1171; Université Lille; F-59000 Lille France
| | - Christian Noel
- Service de Néphrologie; CHU Lille; F-59000 Lille France
- Inserm U995 - LIRIC - Lille Inflammation Research International Center; Université Lille; F-59000 Lille France
| | - Pascal Odou
- Institut de pharmacie; CHU Lille; F-59000 Lille France
- EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées; Université Lille; F-59000 Lille France
| | - Marc Hazzan
- Service de Néphrologie; CHU Lille; F-59000 Lille France
- Inserm U995 - LIRIC - Lille Inflammation Research International Center; Université Lille; F-59000 Lille France
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20
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Altieri M, Delaval G, Kimmoun E, Allaire M, Salamé E, Dumortier J. Conversion From Once-Daily Prolonged-Release Tacrolimus to Once-Daily Extended-Release Tacrolimus in Stable Liver Transplant Recipients. EXP CLIN TRANSPLANT 2017; 16:321-325. [PMID: 28697715 DOI: 10.6002/ect.2016.0328] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
Abstract
OBJECTIVES After organ transplant, strategies to simplify the therapeutic regimen may improve adherence and prevent rejection and/or graft loss. The aim of the present study was to evaluate the safety of conversion from once-daily prolonged-release tacrolimus (Advagraf; Astellas Pharma Europe Limited, Middlesex, UK) to once-daily extended-release tacrolimus (Envarsus; Chiesi SAS, Nanterre, France) in stable adult liver transplant recipients. MATERIALS AND METHODS This observational study inclu-ded 44 liver transplant patients (median age of 59 y; 63.6% men; median delay after transplant of 72.5 mo). Conversion was based on a 1:0.70 proportion. RESULTS Mean dose of tacrolimus was 2.65 ± 1.24 mg/day before conversion and 2.09 ± 1.68 mg/day after conversion (P < .05), with ratio of 1:0.79. Mean serum tacrolimus trough level increased after conversion (4.92 ± 1.65 vs 5.60 ± 2.89 ng/mL; P < .05), with ratio of 1:1.14. Six months after conversion, mean dose of tacrolimus was 1.65 ± 0.93 mg/day (ratio of 1:0.62) and mean serum tacrolimus trough level was 4.82 ± 1.85 ng/mL, similar to the initial level before conversion. At the end of follow-up, 2 patients had returned to once-daily prolonged-release tacrolimus because of adverse effects (allergy, digestive trouble), which resolved thereafter. The mean cost of tacrolimus therapy was 5.54 ± 2.29 Euros/patient/day before conversion and 4.11 ± 2.32 Euros/patient/day after conversion (P < .05). CONCLUSIONS Conversion from prolonged-release to extended-release tacrolimus in stable liver transplant patients is safe and cost-effective; however, initially, dose adaptations and careful monitoring are required.
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Affiliation(s)
- Mario Altieri
- >From the service d'Hépato-Gastroentérologie, Nutrition et Oncologie Digestive, Hôpital Côte de Nacre, Caen, France
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21
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The Influence of Timing and Frequency of Adipose-Derived Mesenchymal Stem Cell Therapy on Immunomodulation Outcomes After Vascularized Composite Allotransplantation. Transplantation 2017; 101:e1-e11. [PMID: 27893612 DOI: 10.1097/tp.0000000000001498] [Citation(s) in RCA: 40] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/14/2023]
Abstract
BACKGROUND Cellular therapies for immunomodulation in vascularized composite allotransplantation (VCA) have gained importance due to their potential for minimization of immunosuppression. Adipose-derived (AD) mesenchymal stem cells (MSCs) especially have shown encouraging potential. We investigated the influence of timing and frequency of AD-MSC treatment on immunologic and graft survival as well as graft vasculopathy outcomes after VCA. METHODS Lewis rats received full-mismatched Brown Norway rat hindlimb transplants. Recipient animals were assigned to groups receiving donor-derived AD-MSCs (10 cells/animal) either on postoperative day (POD) 1, POD 4, or repeatedly on POD 4, 8, and 15, and compared to untreated controls. RESULTS Although AD-MSC administration on POD 1 or POD 4, 8, and 15 resulted in 50% long-term graft acceptance, recipients treated on POD 4, and controls rejected before POD 50. All treated animals revealed peripheral blood chimerism (4 weeks), most pronounced after repetitive cell administration (12.92% vs 5.03% [POD 1] vs 6.31% [POD 4]; P < 0.05; all P < 0.01 vs control 1.45%). Chimerism was associated with the generation of regulatory T cells (CD4CD25FoxP3). In vitro mixed lymphocyte reactions revealed modulation of the recipient immune response after AD-MSC treatment. Graft arteries at end point revealed significant differences of arterial intimal thickness between rejecting and AD-MSC-treated animals (P < 0.01). CONCLUSIONS Taken together, our results point to the potential for repetitive AD-MSC administration in improving outcomes after VCA. Future studies are warranted into optimization of the dosing and frequency of AD-MSC therapy, either alone or used in, combination with other cell therapies (such as hematopoietic stem cells or bone marrow-derived MSC or dendritic cells) for optimization of appropriate conditioning or maintenance regimens.
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22
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Zhu Y, Zhou Y, Zhang L, Zhang J, Lin J. Efficacy of interventions for adherence to the immunosuppressive therapy in kidney transplant recipients: a meta-analysis and systematic review. J Investig Med 2017; 65:1049-1056. [PMID: 28483983 PMCID: PMC5847104 DOI: 10.1136/jim-2016-000265] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/13/2017] [Indexed: 01/23/2023]
Abstract
Immunosuppressive treatment regimens are complex and require ongoing self-management. Medication adherence can be difficult to achieve for several reasons. The current meta-analysis and systematic review investigated whether adherence interventions improved immunosuppressive treatment adherence in kidney transplant recipients. Medline, Cochrane, EMBASE, and Google Scholar were searched until October 17, 2016 using the following search terms: kidney transplantation, compliance, adherence, and immunosuppressive therapy. Randomized controlled trials and two-arm prospective, retrospective, and cohort studies were included. The primary outcomes were adherence rate and adherence score. Eight studies were included with a total for 546 patients. Among participants receiving intervention, the adherence rate was significantly higher than the control group (pooled OR=2.366, 95% CI 1.222 to 4.578, p=0.011). Participants in the intervention group had greater adherence scores than those in the control group (pooled standardized difference in means =1.706, 95% CI 0.346 to 3.065, p=0.014). Sensitivity analysis indicated that findings for adherence rate were robust. However, for adherence score, the significance of the association disappeared after removing one of the studies indicating the findings may have been overly influenced by this one study. Intervention programs designed to increase immunosuppressive adherence in patients with kidney transplant improve treatment adherence.
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Affiliation(s)
- Yichen Zhu
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
| | - Yifan Zhou
- National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA
| | - Lei Zhang
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
| | - Jian Zhang
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
| | - Jun Lin
- Department of Urology, Capital Medical University Beijing Friendship Hospital, Beijing, China.,Beijing Key Laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China
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23
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Belaiche S, Décaudin B, Dharancy S, Noel C, Odou P, Hazzan M. Factors relevant to medication non-adherence in kidney transplant: a systematic review. Int J Clin Pharm 2017; 39:582-593. [PMID: 28374343 DOI: 10.1007/s11096-017-0436-4] [Citation(s) in RCA: 76] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2016] [Accepted: 02/06/2017] [Indexed: 01/14/2023]
Abstract
Background Medication non-adherence is a major issue after transplant that can lead to misdiagnosis, rejection, poor health affecting quality of life, graft loss or death. Several estimations of adherence and related factors have previously been described but conclusions leave doubt as to the most accurate assessment method. Aim of the review To identify the factors most relevant to medication non-adherence in kidney transplant in current clinical practice. Method This systematic review is registered in the PROSPERO data base and follows the Prisma checklist. Articles in English in three databases from January 2009 to December 2014 were analysed. A synthesis was made to target adherence assessment methods, their prevalence and significance. Results Thirty-seven studies were analysed rates of non-adherence fluctuating from 1.6 to 96%. Assessment methods varied from one study to another, although self-reports were mainly used. It appears that youth (≤50 years old), male, low social support, unemployment, low education, ≥3 months post graft, living donor, ≥6 comorbidities, ≥5 drugs/d, ≥2 intakes/d, negative beliefs, negative behavior, depression and anxiety were the factors significantly related to non-adherence. Conclusion As there are no established guidelines, consideration should be given to more than one approach to identify medication non-adherence although self-reports should remain the cornerstone of adherence assessment.
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Affiliation(s)
- Stephanie Belaiche
- Institut de pharmacie, CHU Lille, 59000, Lille, France. .,EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Univ. Lille, 59000, Lille, France.
| | - Bertrand Décaudin
- Institut de pharmacie, CHU Lille, 59000, Lille, France.,EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Univ. Lille, 59000, Lille, France
| | - Sébastien Dharancy
- Service des Maladies de l'appareil digestif et de la Nutrition, CHU Lille, 59000, Lille, France.,Inserm U995 - LIRIC - Lille Inflammation Research International Center, Univ. Lille, 59000, Lille, France
| | - Christian Noel
- Service de Néphrologie, CHU Lille, 59000, Lille, France.,Inserm U995 - LIRIC - Lille Inflammation Research International Center, Univ. Lille, 59000, Lille, France
| | - Pascal Odou
- Institut de pharmacie, CHU Lille, 59000, Lille, France.,EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Univ. Lille, 59000, Lille, France
| | - Marc Hazzan
- Service de Néphrologie, CHU Lille, 59000, Lille, France.,Inserm U995 - LIRIC - Lille Inflammation Research International Center, Univ. Lille, 59000, Lille, France
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24
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Wadström J, Ericzon BG, Halloran PF, Bechstein WO, Opelz G, Serón D, Grinyó J, Loupy A, Kuypers D, Mariat C, Clancy M, Jardine AG, Guirado L, Fellström B, O'Grady J, Pirenne J, O'Leary JG, Aluvihare V, Trunečka P, Baccarani U, Neuberger J, Soto-Gutierrez A, Geissler EK, Metzger M, Gray M. Advancing Transplantation: New Questions, New Possibilities in Kidney and Liver Transplantation. Transplantation 2017; 101 Suppl 2S:S1-S41. [PMID: 28125449 DOI: 10.1097/tp.0000000000001563] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Affiliation(s)
- Jonas Wadström
- 1 Karolinska University Hospital, Stockholm, Sweden. 2 Karolinska Institutet, Stockholm, Sweden. 3 Alberta Transplant Applied Genomics Centre, Edmonton, Canada. 4 Frankfurt University Hospital and Clinics, Frankfurt, Germany. 5 University of Heidelberg, Heidelberg, Germany. 6 Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Spain. 7 Red de Investigación Renal (REDinREN), Instituto Carlos III, Madrid, Spain. 8 Hospital Universitari de Bellvitge, University of Barcelona, Spain. 9 Service de Néphrologie-Transplantation, Hôpital Necker, Paris, France. 10 University Hospitals Leuven, Leuven, Belgium. 11 University Hospital of Saint-Etienne, Jean Monnet University, France. 12 Western Infirmary, Glasgow, United Kingdom. 13 Fundació Puigvert, Barcelona, Spain. 14 University of Uppsala, Uppsala, Sweden. 15 King's College Hospital, London, United Kingdom. 16 Baylor University Medical Center Dallas, Dallas, TX. 17 Transplantcenter, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic. 18 Department of Medical and Biological Sciences, University Hospital of Udine, Udine, Italy. 19 Liver Unit, Queen Elizabeth Hospital, Birmingham, United Kingdom. 20 Directorate of Organ Donation and Transplantation, NHS Blood and Transplant, Bristol, United Kingdom. 21 Department of Pathology, University of Pittsburgh, Pittsburgh, PA. 22 Experimental Surgery, University Hospital Regensburg, University of Regensburg, Regensburg, Germany. 23 Ahead of Time GmbH, Starnberg, Germany. 24 Better Value Healthcare, Oxford, United Kingdom
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25
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Immunosuppressive Medication Adherence in Liver Transplant Recipients. Transplant Proc 2017; 48:1198-201. [PMID: 27320586 DOI: 10.1016/j.transproceed.2015.12.097] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2015] [Accepted: 12/30/2015] [Indexed: 11/21/2022]
Abstract
BACKGROUND Immunosuppressive medication is one of the pivotal factors in the outcome of liver transplant patients. Nonadherence to immunosuppressive therapy is a common problem after transplantation and affects graft and patient survival. This study aimed to assess immunosuppressive medication adherence in liver transplant recipients. METHODS Liver transplant recipients who underwent the Siriraj-Support Medication Adherence in Organ Transplantation (S-SMAOT) program were included in this cross-sectional study. Immunosuppressive medication adherence was assessed with the use of the Immunosuppressive Therapy Adherence Scale (ITAS, which is scored from 0 to 12; very poor to excellence adherence). The correlations between ITAS scores and the clinical profiles of the patients, duration after transplantation, and transplant educational scores post-test were also analyzed. RESULTS From October 2012 to September 2014, a total of 50 liver transplant recipients (86 visits) were enrolled in this study. The ratio of male to female patients was 48:52. The proportions of patients with ITAS scores of 12, 10-11, and 0-9 were 82.6%, 16.3% and 1.2%, respectively. ITAS score was significantly correlated with the duration after transplantation (P < .001) and the educational scores (P = .009). CONCLUSIONS Consistent assessment of patients' immunosuppressive medication adherence is essential to avoid problems of noncompliance and to improve the outcome after liver transplantation. The S-SMAOT program was an effective approach to significantly improve the medication adherence in liver transplant recipients.
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26
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Liu LS, Li J, Chen XT, Zhang HX, Fu Q, Wang HY, Xiong YY, Liu S, Liu XM, Li JL, Huang M, Wang CX. Comparison of tacrolimus and cyclosporin A in CYP3A5 expressing Chinese de novo kidney transplant recipients: a 2-year prospective study. Int J Clin Pract 2016:43-52. [PMID: 26177348 DOI: 10.1111/ijcp.12666] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/08/2023] Open
Abstract
AIMS To assess the efficacy and safety of tacrolimus and cyclosporin A (CsA)-based immunosuppressive regimens in Chinese de novo kidney transplant recipients who are CYP3A5 expressers. METHODS The CYP3A5 (6986 A>G, rs776746) polymorphism of eligible patients was determined before transplantation. De novo kidney transplant recipients enrolled in this study were assigned to tacrolimus (Tac group) or CsA (CsA group) based therapy. The follow-up period was 2 years. The incidence of acute rejection, patient and graft survival rates, renal allograft function and post-transplant complications were compared. The intra-individual variability (IIV) of Tac and CsA blood concentrations was analysed. Medication costs were also compared. The analysis was conducted on the intention-to-treat principle. RESULTS A total of 72 CYP3A5 expressers were enrolled, with 36 patients in each group. AR incidence was higher in the Tac group (11.1% vs. 5.6%), but there was no significant difference (p > 0.05). The 2-year patient and graft survival was comparable, and renal function was comparable in the two groups. Notably, the Tac group presented a significantly higher incidence of BK viremia (22.2% vs. 5.6%, p < 0.05) and BK viruria (38.9% vs. 16.7%, p < 0.05) than the CsA group. The CsA IIV at 1 and 3 months post-transplant was significantly lower than the Tac IIV (p < 0.05). The medical costs of both immunosuppressive drugs and management of complications was significantly lower in the CsA group. CONCLUSIONS Cyclosporin A-based maintenance therapy is safe for Chinese de novo kidney transplant recipients who are CYP3A5 expressers. CsA significantly reduced medication costs and decreased BKV infection, suggesting that it is more beneficial for this specific population.
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Affiliation(s)
- L-S Liu
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
| | - J Li
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
| | - X-T Chen
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
| | - H-X Zhang
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
| | - Q Fu
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
| | - H-Y Wang
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
| | - Y-Y Xiong
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
| | - S Liu
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
| | - X-M Liu
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
| | - J-L Li
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
| | - M Huang
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
| | - C-X Wang
- Organ Transplant Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
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27
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La transplantation rénale et ses défis. Prog Urol 2016; 26:1001-1044. [PMID: 27720627 DOI: 10.1016/j.purol.2016.09.056] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/07/2016] [Accepted: 09/12/2016] [Indexed: 01/09/2023]
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Gastaca M, Valdivieso A, Bustamante J, Fernández JR, Ruiz P, Ventoso A, Testillano M, Palomares I, Salvador P, Prieto M, Montejo M, Suárez MJ, de Urbina JO. Favorable longterm outcomes of liver transplant recipients treated de novo with once-daily tacrolimus: Results of a single-center cohort. Liver Transpl 2016; 22:1391-400. [PMID: 27434676 DOI: 10.1002/lt.24514] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2016] [Revised: 05/31/2016] [Accepted: 06/21/2016] [Indexed: 12/15/2022]
Abstract
The once-daily prolonged-release formulation of tacrolimus has been recently related with significant graft and patient mid-term survival advantages; however, practical information on the de novo administration after liver transplantation and longterm outcomes is currently lacking. This study is a 5-year retrospective analysis of a single-center cohort of liver transplant recipients treated de novo with once-daily tacrolimus (April 2008/August 2011). The study cohort consisted of 160 patients, including 23 with pretransplant renal dysfunction, with a median follow-up of 57.6 months (interquartile range, 46.6-69.0). Tacrolimus target trough levels were 5-10 ng/mL during the first 3 months after transplant, reducing progressively to <7 ng/mL after the first posttransplant year. Once-daily tacrolimus was withdrawn in 35 (21.8%) patients during follow-up, mostly due to renal dysfunction and/or metabolic syndrome. The biopsy-proven acute rejection rate was 12.5% with no cases of steroid-resistant rejection. The cumulative incidence of de novo diabetes, hypertension, and dyslipidemia were 16.9%, 31.2%, and 6.5%, respectively. Hepatocellular carcinoma recurrence rate was 2.8%. Renal function remained stable after the sixth month after transplant with a mean estimated glomerular filtration rate of 77.7 ± 19.6 mL/minute/1.73 m(2) at 5 years. None of our patients developed chronic kidney disease stage 4 or 5. Patient survival at 1, 3, and 5 years was 96.3%, 91.9%, and 88.3%, respectively. Overall survival of patients with Model for End-Stage Liver Disease (MELD) score > 25 points was not significantly different. In conclusion, our study suggests that immunosuppression based on de novo once-daily tacrolimus is feasible in routine clinical practice, showing favorable outcomes and outstanding longterm survival even in patients with high MELD scores. Liver Transplantation 22 1391-1400 2016 AASLD.
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Affiliation(s)
- Mikel Gastaca
- Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain. .,University of the Basque Country, Leioa, Spain.
| | - Andrés Valdivieso
- Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain.,University of the Basque Country, Leioa, Spain
| | - Javier Bustamante
- Liver Diseases Unit, Cruces University Hospital, Bilbao, Spain.,University of the Basque Country, Leioa, Spain
| | | | - Patricia Ruiz
- Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain
| | - Alberto Ventoso
- Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain
| | | | - Ibone Palomares
- Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain
| | | | - Mikel Prieto
- Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain
| | - Miguel Montejo
- Infectious Diseases Unit, Cruces University Hospital, Bilbao, Spain.,University of the Basque Country, Leioa, Spain
| | - María J Suárez
- Liver Diseases Unit, Cruces University Hospital, Bilbao, Spain
| | - Jorge Ortiz de Urbina
- Hepatobiliary Surgery and Liver Transplantation Unit, Cruces University Hospital, Bilbao, Spain
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Oliveira RA, Turrini RNT, Poveda VDB. Adherence to immunosuppressive therapy following liver transplantation: an integrative review. Rev Lat Am Enfermagem 2016; 24:e2778. [PMID: 27579933 PMCID: PMC5016054 DOI: 10.1590/1518-8345.1072.2778] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/17/2015] [Accepted: 03/28/2016] [Indexed: 03/13/2023] Open
Abstract
OBJECTIVE to investigate the evidence available in the literature on non-adherence to immunosuppressive therapy among patients undergoing liver transplantation. METHOD integrative literature review, including research whose sample consisted of patients aged over 18 years undergoing liver transplantation. It excluded those containing patients undergoing multiple organ transplants. For the selection of articles, Medline / Pubmed, CINAHL, LILACS, Scopus and Embase were searched. The search period corresponded to the initial date of indexation of different bases, up to the deadline of February 10, 2015, using controlled and uncontrolled descriptors: liver transplantation, hepatic transplantation, liver orthotopic transplantation, medication adherence, medication non-adherence, medication compliance and patient compliance. RESULTS were located 191 investigations, 10 of which met the objectives of the study and were grouped into four categories, namely: educational process and non-adherence; non-adherence related to the number of daily doses of immunosuppressive medications; detection methods for non-adherence and side effects of therapy. CONCLUSION there were risk factors related to the health service, such as control and reduction of the number of doses; related to the individual, such as being male, divorced, alcohol or other substances user, exposed to low social support and being mentally ill.
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Affiliation(s)
- Ramon Antônio Oliveira
- Master's Student, Escola de Enfermagem, Universidade de São Paulo, São Paulo, SP, Brazil
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30
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Costa-Requena G, Cantarell MC, Moreso F, Parramon G, Seron D. [Adherence to treatment after kidney transplantation as quality indicator of the information received: Longitudinal study of 2 years follow-up]. ACTA ACUST UNITED AC 2016; 32:33-39. [PMID: 27425627 DOI: 10.1016/j.cali.2016.05.004] [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: 02/09/2016] [Revised: 05/05/2016] [Accepted: 05/06/2016] [Indexed: 11/25/2022]
Abstract
INTRODUCTION Transplantation is an optimal form of treatment for end-stage renal disease, but requires lifelong adherence to immunosuppressive therapy. The aim of this study was to longitudinally assess the adherence to treatment after kidney transplant, as well as to compare the amount of information about the treatment received at one month and 18 months post-transplantation, and its influence on adherence to treatment. MATERIAL AND METHODS The Self-Reported Measure of Medication Adherence was administered at month (T1), 6 months (T2), 12 months (T3), 18 months (T4), and 24 months (T5) post-transplantation. Survey about aspects of knowledge and attitudes about medication, was administered at one month and 18 months post-transplant. Measures of central tendency and non-parametric tests were used to compare the data. RESULTS The study included a total of 73 patients with a median age of 57 years. The percentage of patients non-adherent to medication was 9.6% (T1), 22.5% (T2), 29.2% (T3), 29.8% (T4), and 28.1% (T5). One month after transplantation "not consulting with the doctor on forgetting to take medication (P=.034) significantly influenced the non-adherence to treatment. At 18 months post- transplantation, none of the issues raised on medication knowledge had an influence on non-adherence to treatment. CONCLUSIONS Longer times since transplantation increased the non-adherence to treatment. Some issues regarding the information of treatment influenced the non-adherence in the immediate transplant period, but not in the follow-up.
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Affiliation(s)
- G Costa-Requena
- Servicio de Psiquiatría, Hospital General Universitari Vall d'Hebron, CIBERSAM, Universitat Autònoma de Barcelona, Barcelona, España.
| | - M C Cantarell
- Servicio de Nefrología, Hospital General Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, España
| | - F Moreso
- Servicio de Nefrología, Hospital General Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, España
| | - G Parramon
- Servicio de Psiquiatría, Hospital General Universitari Vall d'Hebron, CIBERSAM, Universitat Autònoma de Barcelona, Barcelona, España
| | - D Seron
- Servicio de Nefrología, Hospital General Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, España
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Abstract
BACKGROUND Graft failure risk is highest during emerging adulthood (17-24 years) in kidney and heart transplant. It is unknown whether a similar association exists in liver transplant recipients. METHODS We sought to estimate the relative hazards of graft failure at different current ages, compared with those aged 21 to 24 years. We evaluated 17 181 patients recorded in the Scientific Registry of Transplant Recipients who received a first isolated liver transplant at 40 years or younger (1988-2013) and had 6 months or longer of graft function. We used time-dependent Cox models to estimate the association between current age and failure risk, defined as retransplant or death after graft failure; observation was censored at death with graft function. RESULTS There were 2540 failures. Absolute graft failure rates were highest in ages 25 to 29 years (3.0/100 person-years). Compared with individuals with the same time since transplantation, those aged 21 to 24 years had significantly higher failure rates than those younger than 17 years and older than 34 years; hazards did not differ for those aged 25 to 29 years (1.03 [0.86, 1.24]) and were lower, but not significantly, for those aged 17 to 20 years (hazards ratio, 0.83; 95% confidence interval, 0.68-1.01) and ages 30 to 34 years (hazards ratio, 0.84; 95% confidence interval, 0.70-1.01). CONCLUSIONS Among young first isolated liver transplant recipients, graft failure risks are highest in the period from 21 to 29 years of age.
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Patel N, Cook A, Greenhalgh E, Rech MA, Rusinak J, Heinrich L. Overview of extended release tacrolimus in solid organ transplantation. World J Transplant 2016; 6:144-154. [PMID: 27011912 PMCID: PMC4801790 DOI: 10.5500/wjt.v6.i1.144] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/05/2015] [Revised: 10/28/2015] [Accepted: 01/04/2016] [Indexed: 02/05/2023] Open
Abstract
Tacrolimus (Prograf©, Astellas Pharma Europe Ltd, Staines, United Kingdom; referred to as tacrolimus-BID) is an immunosuppressive agent to prevent and treat allograft rejection in kidney transplant recipients in combination with mycophenolate mofetil, corticosteroids, with or without basiliximab induction. The drug has also been studied in liver, heart and lung transplant; however, these are currently off-label indications. An extended release tacrolimus formulation (Advagraf©, Astagraf XL©) allows for once-daily dosing, with the potential to improve adherence. Extended release tacrolimus has similar absorption, distribution, metabolism and excretion to tacrolimus-BID. Phase I pharmacokinetic trials comparing extended release tacrolimus and tacrolimus-BID have demonstrated a decreased maximum concentration (Cmax) and delayed time to maximum concentration (tmax) with the extended release formulation; however, AUC0-24 was comparable between formulations. Overall extended release tacrolimus has a very similar safety and efficacy profile to tacrolimus-BID. It is not recommended in the use of liver transplant patient’s due to the increased risk of mortality in female recipients. There has been minimal data regarding the use of extended release tacrolimus in heart and lung transplant recipients. With the current data available for all organ groups the extended release tacrolimus should be dosed in a 1:1 fashion, the exception may be the cystic fibrosis population where their initial dose may need to be higher.
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Jamieson NJ, Hanson CS, Josephson MA, Gordon EJ, Craig JC, Halleck F, Budde K, Tong A. Motivations, Challenges, and Attitudes to Self-management in Kidney Transplant Recipients: A Systematic Review of Qualitative Studies. Am J Kidney Dis 2016; 67:461-78. [DOI: 10.1053/j.ajkd.2015.07.030] [Citation(s) in RCA: 84] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/03/2015] [Accepted: 07/19/2015] [Indexed: 12/20/2022]
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Muduma G, Odeyemi I, Smith-Palmer J, Pollock RF. Review of the Clinical and Economic Burden of Antibody-Mediated Rejection in Renal Transplant Recipients. Adv Ther 2016; 33:345-56. [PMID: 26905265 DOI: 10.1007/s12325-016-0292-y] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/12/2015] [Indexed: 01/29/2023]
Abstract
UNLABELLED Antibody-mediated rejection (AbMR) is a leading cause of late graft loss in kidney transplant recipients, accounting for up to 60% of late graft failures. AbMR manifests as two distinct phenotypes: the first occurs in the immediate post-transplant period in sensitized patients; the second occurs in the late post-transplant period and has been associated with non-adherence to immunosuppression. The present review summarizes the current treatment options for AbMR, its clinical and economic burden, and approaches for reducing the risk of AbMR. While AbMR is typically refractory to treatment with corticosteroids, there are numerous other approaches focused on removal, inhibition or neutralization of donor-specific antibodies, or inhibition of complement-mediated allograft damage. AbMR treatment is generally expensive with one US study reporting costs of USD 49,000-155,000 per episode. However, leaving AbMR untreated puts patients at high risk of capillaritis, microangiopathy, necrosis and graft failure, which may ultimately result in much greater costs associated with a return to dialysis. Given the barriers to treatment, which include the high cost and the fact that pharmacologic treatments are currently used off-label, prevention of AbMR is important, with improvement in patient adherence to immunosuppression a key strategic approach that may be worthy of further evaluation. FUNDING Astellas Pharma EMEA Limited.
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Oberlin SR, Parente ST, Pruett TL. Improving medication adherence among kidney transplant recipients: Findings from other industries, patient engagement, and behavioral economics-A scoping review. SAGE Open Med 2016; 4:2050312115625026. [PMID: 26835016 PMCID: PMC4724760 DOI: 10.1177/2050312115625026] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2015] [Accepted: 11/29/2015] [Indexed: 12/17/2022] Open
Abstract
The immune system is a powerful barrier to successful organ transplantation, but one that has been routinely thwarted through modern pharmacotherapeutics. Despite the benefits of immunosuppressive therapy, medication non-adherence leads to an increased risk of graft rejection, higher hospital utilization and costs, and poor outcomes. We conduct a scoping review following Arksey and O'Malley's five-stage framework methodology to identify established or novel interventions that could be applied to kidney transplant recipients to improve medication adherence. As the desired outcome is a behavior (taking a pill), we assess three areas: behavioral-focused interventions in other industries, patient engagement theories, and behavioral economic principles. Search strategies included mining business, social sciences, and medical literature with additional guidance from six consultative interviews. Our review suggests that no intervention stands out as superior or likely to be more effective than any other intervention; yet promising strategies and interventions were identified across all three areas examined. Based on our findings, we believe there are five strategies that transplant centers and other organizations can implement to improve medication adherence: (1) Build a foundation of trust; (2) Employ multiple interventions; (3) Stratify the population; (4) Develop collaborative partnerships; and (5) Embed medication adherence into the organization's culture. The effectiveness of these interventions will need to be investigated further, but we believe they are a step in the right direction for organizations to consider in their efforts to improve medication adherence.
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Affiliation(s)
| | - Stephen T Parente
- Health Systems Innovation Network, LLC, Wayzata, MN, USA
- Carlson School of Management, University of Minnesota, Minneapolis, MN, USA
| | - Timothy L Pruett
- Division of Transplantation, Department of Surgery, University of Minnesota, Minneapolis, MN, USA
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Repeat Kidney Transplantation After Failed First Transplant in Childhood: Past Performance Informs Future Performance. Transplantation 2015; 99:1700-8. [PMID: 25803500 DOI: 10.1097/tp.0000000000000686] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
BACKGROUND AND OBJECTIVES Kidney transplant graft survival is almost uniformly superior for initial transplants compared to repeat transplants. We investigate the association between first second kidney transplant graft survival in patients who underwent initial transplant during their pediatric years whether age at second transplant is associated with outcome. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS This is a retrospective analysis of Organ Procurement and Transplantation Network data from October 1987 to May 2009 examining second kidney graft survival in 2281 patients who received their first transplant at younger than 18 years using Kaplan-Meier statistics. Factors associated with second graft survival were identified using a multivariable Cox proportional hazards model. RESULTS Patients with first kidney graft survival of less than 5 years had better second graft survival compared to patients with first graft survival of 30 days to 5 years (P < 0.01). Patients with first kidney graft survival less than 30 days had similar second kidney graft outcomes(P = 0.50) as those with longer than 5 years first kidney graft survival, demonstrating that very early first graft loss is not associated with poor second transplant outcome. Patients 15 to 20 years of age at second transplant have lower second graft survival compared to other age groups; P less than 0.01, regardless of other recipient/donor characteristics and recurrent disease. CONCLUSIONS Poor second transplant outcomes are identified among patients with previous pediatric kidney transplant with first graft survival longer than 30 days, but shorter than 5 years, and those receiving second transplants at a high-risk age category (15-20 years). These groups may benefit from increased attention both before and after transplantation.
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Pabst S, Bertram A, Zimmermann T, Schiffer M, de Zwaan M. Physician reported adherence to immunosuppressants in renal transplant patients: Prevalence, agreement, and correlates. J Psychosom Res 2015; 79:364-71. [PMID: 26526310 DOI: 10.1016/j.jpsychores.2015.09.001] [Citation(s) in RCA: 46] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/18/2015] [Revised: 09/12/2015] [Accepted: 09/14/2015] [Indexed: 12/30/2022]
Abstract
OBJECTIVE Adherence to immunosuppressants (IS) is crucial to prevent allograft rejection. Even though there is evidence that non-adherence to IS among kidney transplant recipients is common, it is rarely routinely assessed in clinical practice. Especially, little is known about how physicians estimate patients' adherence to IS medication. METHODS In a single center, cross-sectional study adult patients at least 1 year after kidney transplantation were asked to complete measures of adherence (BAASIS©, Transplant Effect Questionnaire) and of general psychopathology (anxiety, depression, perceived social support). Also the physicians were asked to estimate their patients' adherence. Medical data (time since transplantation, treatment for rejection, IS serum trough levels and target levels) were taken from the patients' charts. RESULTS Physicians rated 22 of 238 (9.2%) patients as non-adherent. Physicians' estimations of non-adherence were lower compared to the results of the self-ratings and biopsy-proven rejections. No association was found between physicians' estimates and the variability of IS through levels. Significantly more women and patients who reported that their native language was not German were rated as non-adherent by the physicians. Also, physician-rated non-adherent patients reported significantly higher depression and anxiety scores as well as less social support compared to adherent patients. CONCLUSION Our results suggest that physicians tend to underestimate patient non-adherence to IS medication. They appear to use observable cues such as sex, language skills, and elevated anxiety and depression scores in particular, to make inferences about an individual patient's adherence. Underestimation of medication non-adherence may impede physicians' ability to provide high quality care.
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Affiliation(s)
- Selma Pabst
- Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Germany
| | - Anna Bertram
- Department of Nephrology and Hypertension, Hannover Medical School, Germany
| | - Tanja Zimmermann
- Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Germany
| | - Mario Schiffer
- Department of Nephrology and Hypertension, Hannover Medical School, Germany
| | - Martina de Zwaan
- Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Germany.
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Coilly A, Calmus Y, Chermak F, Dumortier J, Duvoux C, Guillaud O, Houssel-Debry P, Neau-Cransac M, Stocco J. Once-daily prolonged release tacrolimus in liver transplantation: Experts' literature review and recommendations. Liver Transpl 2015; 21:1312-21. [PMID: 26264233 DOI: 10.1002/lt.24228] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/16/2015] [Revised: 06/22/2015] [Accepted: 06/28/2015] [Indexed: 02/07/2023]
Abstract
The efficacy and safety of tacrolimus (Tac) twice daily (bid) and once a day (qd) formulations are considered to be similar. However, the available information regarding initiation of Tac qd is sparse, and practical information is lacking. On the basis of a literature review, clinical efficacy, and safety trials, French experts in the liver transplantation field were asked to highlight pharmacokinetic (PK) differences between both formulations to assess efficacy and safety of the qd formulation in the context of de novo initiation or conversion and to provide their recommendations for initiation and day-to-day management of Tac qd. The same efficacy and safety profile is found for both immediate-release and prolonged-release Tac. PK differences carry on absorption because of the difference in formulations but not on metabolism or excretion. Tac qd offers a better reproducibility in exposure than Tac bid but is associated with an increased risk of disturbed absorption in case of a change in intestinal motility. The same therapeutic drug monitoring with Tac qd and bid could be applied, based on minimal concentration (trough level; C(min)), as there is a similar strong correlation between C(min) and the area under the curve (AUC) for both formulations. Different protocols for Tac qd initiation were described through numerous studies, except for early conversion: initiation on day 0, using 0.10 to 0.20 mg/kg/day as monotherapy, or lower dosages in case of concomitant immunosuppressant treatment or poor graft quality; early conversion from day 5 to 6 months, preferably before hospital discharge, using a 1 to 1.3 mg/kg/day schedule and with first C(min) assessment 48 hours after the conversion; and later conversion (>6 months posttransplantation) using a milligram-to-milligram dosage schedule, and with dose adjustment based on weekly C(min) measurement. Experts underline that an increase in treatment adherence was expected using Tac qd in liver recipients. In conclusion, Tac qd has the same efficacy and safety profile as Tac bid. De novo introduction or later conversion are well documented but could differ from day-to-day practice.
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Affiliation(s)
- Audrey Coilly
- Centre Hepato-Biliaire, AP-HP Hôpital Paul Brousse, Villejuif, France.,Unit 1193, INSERM, Villejuif, France.,Unités Mixtes de Recherche en Santé 1193, Universite Paris-Sud, Villejuif, France
| | - Yvon Calmus
- Service d'Hépatologie et de Transplantation Hépatique, AP-HP Hôpital Saint-Antoine, Paris, France
| | - Faiza Chermak
- Centre d'investigation de la Fibrose Hépatique, Centre Hospitalier Universitaire de Bordeaux Hôpital Haut-Lévêque, Pessac, France
| | - Jerome Dumortier
- Unité de Transplantation Hépatique, Hopital Edouard Herriot, Hospices Civils de Lyon, Lyon, France
| | | | - Olivier Guillaud
- Unité de Transplantation Hépatique, Hopital Edouard Herriot, Hospices Civils de Lyon, Lyon, France
| | - Pauline Houssel-Debry
- Service des Maladies du Foie, Hôpital Pontchaillou, Centre Hospitalier Universitaire de Rennes, Rennes, France
| | - Martine Neau-Cransac
- Service de Transplantation Hepatique, Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin, Bordeaux, France
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Srinivas TR, Oppenheimer F. Identifying endpoints to predict the influence of immunosuppression on long-term kidney graft survival. Clin Transplant 2015; 29:644-53. [DOI: 10.1111/ctr.12554] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/17/2015] [Indexed: 01/12/2023]
Affiliation(s)
- Titte R. Srinivas
- Kidney and Pancreas Transplant Programs; Division of Nephrology; Medical University of South Carolina; Mount Pleasant SC USA
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Ortega F, Díaz-Corte C, Valdés C. Adherence to immunosuppressor medication in renal transplanted patients. World J Clin Urol 2015; 4:27-37. [DOI: 10.5410/wjcu.v4.i1.27] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/25/2014] [Revised: 05/27/2014] [Accepted: 12/17/2014] [Indexed: 02/06/2023] Open
Abstract
Non-adherence is a priority public health concern. Non-adherence means not taking medications, missing medications, taking too much, not taking enough, wrong timing, wrong dose and/or wrong pill, but may also refer to missing appointments, not booking appointments, not doing blood work, not returning calls and/or refusal to follow the treatment regimen. In renal transplantation, adherence to immunosuppressive medication is a fundamental requisite in order to preserve graft function, since non-adherence is one of the main causes for late acute rejection, incomplete recovery after rejection treatment, chronic graft dysfunction, graft loss, and death. Transplantation failure due to treatment non-adherence is economically, socially, ethically and morally unjustifiable. This is a very prevalent issue: in some studies, its incidence is as high as 70% of patients. The self-reported nonadherence levels found in certain studies, including those performed immediately after transplantation show the need for early and continued intervention after kidney transplantation in order to maximise adherence and consequently clinical outcomes. There is not a single method to assess non adherence, thus combining several measures increases diagnostic accuracy. Electronic monitoring with a microdevice that records each time a pill bottle is opened is considered the “gold standard” for measuring adherence, but self-report at a confidential interview was the best measure of adherence. Thus non-adherence risk can be effectively assessed using clinically available assessment tools. Medication Adherence Scale, Brief Medical Questionnaire, Immunosuppressant Therapy Adherence Scale, Immunosuppressant Therapy Barrier Scale, Long-Term Medication Behavior Self-Efficacy Scale and Simplified Medication Adherence Questionnaire are some of the self-reported questionnaires. There are multiple factors associated with non-adherence in immunosuppressant therapy: Younger patients (adolescent, especially), poor health coverage, poor social support, unmarried, no family, non-Caucasian, immigrant, lower income, lower socioeconomic class, greater parental distress and lower family cohesion; complex medical regimens, higher number of drugs, longer time after transplant, toxicity, side effects, poor tolerance to medication, higher number of physicians involved, poor provider-patient rapport; psychological (dependency, high levels of anxiety and hostility, poorer behavioral functioning and greater distress in children) and psychiatric (depression) illnesses, low self-efficacy with medicine intake, perception of immunosuppressive therapy as not been necessary to preserve kidney function, forgetfulness, rebelliousness, poor perception of health, poor satisfaction, low Health-related Quality of life, addictions, lack of coping strategies and avoidance behavior; patient morbidity: comorbidity, receiving a transplant from a live donor, retransplantation, and non-insulin-dependent diabetes. The most frequent strategies to promote medication-taking must focus on modifiable risk factors. Reasons for non-adherence are complex and diverse and any successful intervention aimed at improving adherence must be multidimensional. Although effective intervention strategies are needed to improve immunosuppressant therapy adherence, few intervention studies have been conducted in the adult renal transplant population. In this study, we perform an exhaustive review of the different strategies reported in the literature. A number of key reasons for non-adherence are also provided.
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Muduma G, Odeyemi I, Pollock RF. Evaluating the economic implications of non-adherence and antibody-mediated rejection in renal transplant recipients: the role of once-daily tacrolimus in the UK. J Med Econ 2015. [PMID: 26201252 DOI: 10.3111/13696998.2015.1074584] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
BACKGROUND AND AIMS While short-term kidney graft survival has gradually improved over time, improvements in long-term graft survival have been more modest. One key clinical factor limiting improved longer-term outcomes is antibody-mediated rejection (AbMR), the incidence of which appears to be higher in patients who are non-adherent to immunosuppressants. Recent data show that adherence can be improved by reducing pill burden. The aim of the present study was to model the incidence and economic consequences of graft loss and AbMR in patients taking once- vs twice-daily tacrolimus in the UK. METHODS A combined decision tree and Markov model was developed to estimate the incidence of graft failure, AbMR and mortality in renal transplant recipients taking once- vs twice-daily tacrolimus. Underlying rates of graft failure and mortality were derived from UK-specific sources. Proportions of patients adherent to once- vs twice-daily tacrolimus were taken from a recent randomized clinical trial and relative risks of graft failure and AbMR were taken from a prospective, multi-center analysis of 315 patients. Cost data were taken from the British National Formulary and National Health Service reference costs and reported in 2014 pounds sterling. RESULTS Modeling results showed that improved adherence would be associated with reduced incidence of AbMR and graft failure in renal transplant recipients. Based on improvements in adherence resulting from switching from twice-daily to once-daily tacrolimus, the modeling analysis projected cost savings of GBP 4862 per patient over 5 years with Advagraf relative to Prograf, on absolute costs of GBP 40,974 and GBP 45,836, respectively. CONCLUSIONS Using Advagraf in place of Prograf in renal transplant recipients was predicted to be associated with lower pharmacy, dialysis and AbMR treatment costs, with the reduction in AbMR and dialysis costs being driven by improved adherence to the Advagraf regimen and consequent reductions in graft failure and onset of AbMR.
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Affiliation(s)
- G Muduma
- a a Astellas Pharma EMEA Limited , Chertsey , UK
| | - I Odeyemi
- a a Astellas Pharma EMEA Limited , Chertsey , UK
| | - R F Pollock
- b b Ossian Health Economics and Communications , Basel , Switzerland
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Bardet JD, Charpiat B, Bedouch P, Rebillon M, Ducerf C, Gauchet A, Tourette-Turgis C, Allenet B. Illness representation and treatment beliefs in liver transplantation: An exploratory qualitative study. ANNALES PHARMACEUTIQUES FRANÇAISES 2014; 72:375-87. [DOI: 10.1016/j.pharma.2014.05.005] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2014] [Revised: 05/26/2014] [Accepted: 05/27/2014] [Indexed: 01/23/2023]
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Reynolds BC, Talbot D, Baines L, Brown A. Use of belatacept to maintain adequate early immunosuppression in calcineurin-mediated microangiopathic hemolysis post-renal transplant. Pediatr Transplant 2014; 18:E140-5. [PMID: 24815506 DOI: 10.1111/petr.12278] [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] [Accepted: 03/25/2014] [Indexed: 12/30/2022]
Abstract
We report a 17-yr-old boy who developed a microangiopathic hemolytic anemia presumed secondary to tacrolimus shortly following a living-related donor renal transplant. This was initially managed by plasmapheresis. Reinstitution of calcineurin inhibition using cyclosporine led to recurrence of hemolysis, so an alternative agent was needed. He was commenced on monthly intravenous belatacept, with no further recurrence of the hemolysis, and subsequent stable graft function. Modulation via CTLA-4 offers an alternative immunosuppressive tactic if current regimens produce graft threatening adverse effects. The method of administration and frequency of dosage of belatacept also lends itself well to the high-risk period of adolescence and transition. We propose that belatacept may therefore also have utility in difficult cases complicated by poor concordance, common in the adolescent age group.
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Affiliation(s)
- B C Reynolds
- Department of Paediatric Nephrology, Great North Children's Hospital, Newcastle upon Tyne, UK
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45
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Améliorer l’adhésion au traitement en transplantation rénale : un enjeu majeur. Nephrol Ther 2014; 10:145-50. [DOI: 10.1016/j.nephro.2013.11.008] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2013] [Revised: 11/01/2013] [Accepted: 11/02/2013] [Indexed: 11/23/2022]
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Russell CL, Ashbaugh C, Peace L, Cetingok M, Hamburger KQ, Owens S, Coffey D, Webb AW, Hathaway D, Winsett RP, Madsen R, Wakefield MR. Time-in-a-bottle (TIAB): a longitudinal, correlational study of patterns, potential predictors, and outcomes of immunosuppressive medication adherence in adult kidney transplant recipients. Clin Transplant 2014; 27:E580-90. [PMID: 24093614 DOI: 10.1111/ctr.12203] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/13/2013] [Indexed: 10/23/2022]
Abstract
This study examined patterns, potential predictors, and outcomes of immunosuppressive medication adherence in a convenience sample of 121 kidney transplant recipients aged 21 yr or older from three kidney transplant centers using a theory-based, descriptive, correlational, longitudinal design. Electronic monitoring was conducted for 12 months using electronic monitoring. Participants were persistent in taking their immunosuppressive medications, but execution, which includes both taking and timing, was poor. Older age was the only demographic variable associated with medication adherence (r = 0.25; p = 0.005). Of the potential predictors examined, only medication self-efficacy was associated with medication non-adherence, explaining about 9% of the variance (r = 0.31, p = 0.0006). The few poor outcomes that occurred were not significantly associated with medication non-adherence, although the small number of poor outcomes may have limited our ability to detect a link. Future research should test fully powered, theory-based, experimental interventions that include a medication self-efficacy component.
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Affiliation(s)
- Cynthia L Russell
- School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, MO, USA; Research Service, Harry S. Truman Memorial Veterans Hospital, Columbia, MO, USA
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Prihodova L, Nagyova I, Rosenberger J, Majernikova M, Roland R, Groothoff JW, van Dijk JP. Adherence in patients in the first year after kidney transplantation and its impact on graft loss and mortality: a cross-sectional and prospective study. J Adv Nurs 2014; 70:2871-83. [PMID: 24853863 DOI: 10.1111/jan.12447] [Citation(s) in RCA: 55] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/12/2014] [Indexed: 01/06/2023]
Abstract
AIMS To explore the predictive value of adherence to their immunosuppressive medication in kidney transplant recipients in the first year after kidney transplantation as a determinant of graft loss and mortality up to 12 years (prospective analysis) and its association with sociodemographic and medical factors and social support (cross-sectional analysis). BACKGROUND Poor adherence to their immunosuppressive medication in kidney transplant recipients remains the leading preventable cause of poor patient outcomes. DESIGN Prospective and cross-sectional study. METHODS At baseline, 325 patients 3-12 months posttransplantation were invited to participate. Adherence was assessed using collateral reports - a combination of patients' self-evaluation and an estimate by their nephrologist. The patients provided sociodemographic and medical data and completed the End-Stage Renal Disease Symptom Checklist and Multidimensional scale of perceived social support. At follow-up (average 7·1 years), data on patients and graft survival were obtained. All data were collected from 2002-2013. Multinomial regression analysis and Cox regression were performed. RESULTS A total of 297 patients (48·1 (12·8) years, 61·6% men) agreed to participate (response rate 91·4%); 67·4% were considered as fully adherent. Poor adherence was associated with higher risk of graft loss and mortality over 12 years. Female sex, higher education, higher perceived side effects of corticosteroids, better perceived cardiac and renal function and higher perceived family social support in the first year posttransplantation were associated with full adherence to immunosuppressive treatment. CONCLUSIONS Patients with poor adherence to the immunosuppressive medication in the first year after kidney transplantation showed increased likelihood of graft loss and death over 12 years compared with the adherent patients.
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Affiliation(s)
- Lucia Prihodova
- Graduate School Kosice Institute for Society and Health, Medical Faculty, Safarik University, Kosice, Slovak Republic
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Abstract
PURPOSE OF REVIEW Organ transplantation decisions are complex, and psychosocial assessment is an important part of the process. The impact of pretransplant psychotic disorder on posttransplant outcomes is unclear, but some guidelines cite psychosis as a relative contraindication to organ transplantation because of concerns about medication adherence and poor postoperative outcomes. This review explores the evidence for poorer solid organ transplant outcomes for people with preexisting psychotic disorders and discusses future directions for how research can contribute to a better understanding of how organ transplantation outcomes are affected by psychotic illness. RECENT FINDINGS When added to the existing small body of literature, recent findings show a continuing insufficient evidence base to suggest that the presence of psychotic disorder increases risk of poorer adherence and outcomes. The evidence points to social isolation being a key factor in poorer adherence posttransplant. SUMMARY Further research is needed to determine the impact of psychotic disorder on transplant outcomes, but based on current evidence a diagnosis of psychotic disorder should not preclude consideration for organ transplantation.
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De Geest S, Burkhalter H, Bogert L, Berben L, Glass TR, Denhaerynck K. Describing the evolution of medication nonadherence from pretransplant until 3 years post-transplant and determining pretransplant medication nonadherence as risk factor for post-transplant nonadherence to immunosuppressives: the Swiss Transplant Cohort Study. Transpl Int 2014; 27:657-66. [PMID: 24628915 DOI: 10.1111/tri.12312] [Citation(s) in RCA: 100] [Impact Index Per Article: 9.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2014] [Accepted: 03/11/2014] [Indexed: 12/30/2022]
Abstract
Although medication nonadherence (MNA) is a major risk factor for poor outcomes, the evolution of MNA from pre- to 3 years post-transplant among the four major organ transplant groups remains unknown. Therefore, this study described this evolution and investigated whether pretransplant MNA predicts post-transplant immunosuppressive medication nonadherence (IMNA). Adult participants (single transplant, pretransplant and ≤1 post-transplant assessment, using medications pretransplant) in the Swiss Transplant Cohort Study (a prospective nation-wide cohort study) were included. Nonadherence, defined as any deviation from dosing schedule, was assessed using two self-report questions pretransplant and at 6, 12, 24 and 36 months post-transplant. Nonadherence patterns were modelled using generalized estimating equations. The sample included 1505 patients (average age: 52.5 years (SD: 13.1); 36.3% females; 924 renal, 274 liver, 181 lung, 126 heart). The magnitude and variability of self-reported MNA decreased significantly from pretransplant to 6 months post-transplant (OR = 0.21; 95% CI: 0.16-0.27). Post-transplant IMNA increased continuously from 6 months to 3 years post-transplant (OR = 2.75; 95% CI: 1.97-3.85). Pretransplant MNA was associated with threefold higher odds of post-transplant IMNA (OR = 3.10; 95% CI: 2.29-4.21). As pretransplant MNA predicted post-transplant IMNA and a continuous increase in post-transplant IMNA was observed, early adherence-supporting interventions are indispensible.
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Affiliation(s)
- Sabina De Geest
- Institute of Nursing Science, University of Basel, Basel, Switzerland
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Suhling H, Rademacher J, Zinowsky I, Fuge J, Greer M, Warnecke G, Smits JM, Bertram A, Haverich A, Welte T, Gottlieb J. Conventional vs. tablet computer-based patient education following lung transplantation--a randomized controlled trial. PLoS One 2014; 9:e90828. [PMID: 24608864 PMCID: PMC3946627 DOI: 10.1371/journal.pone.0090828] [Citation(s) in RCA: 44] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2013] [Accepted: 01/21/2014] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND Accurate immunosuppression is of critical importance in preventing rejection, while avoiding toxicity following lung transplantation. The mainstay immunosuppressants are calcineurin inhibitors, which require regular monitoring due to interactions with other medications and diet. Adherence to immunosuppression and patient knowledge is vital and can be improved through patient education. Education using tablet-computers was investigated. OBJECTIVE To compare tablet-PC education and conventional education in improving immunosuppression trough levels in target range 6 months after a single education. Secondary parameters were ratio of immunosuppression level measurements divided by per protocol recommended measurements, time and patient satisfaction regarding education. DESIGN Single-centre, open labelled randomised controlled trial. PARTICIPANTS Patients >6 months after lung-transplantation with <50% of calcineurin inhibitor trough levels in target range. INTERVENTION Tablet-pc education versus personal, nurse-led education. MEASUREMENTS Calcineurin inhibitor levels in target range 6 months after education, level variability, interval adherence, knowledge and adherence was studied. As outcome parameter, renal function was measured and adverse events registered. RESULTS Sixty-four patients were 1:1 randomised for either intervention. Levels of immunosuppression 6 months after education were equal (tablet-PC 58% vs. conventional 48%, p = 0.27), both groups improved in achieving a CNI trough level within target range by either education method (delta tablet-PC 29% vs. conventional 20%). In all patients, level variability decreased (-20.4%), whereas interval adherence remained unchanged. Knowledge about immunosuppression improved by 7% and compliance tests demonstrated universal improvements with no significant difference between groups. CONCLUSION Education is a simple, effective tool in improving adherence to immunosuppression. Tablet-PC education was non-inferior to conventional education. TRIAL REGISTRATION ClinicalTrials.gov NCT01398488 http://clinicaltrials.gov/ct2/show/NCT01398488? term=gottlieb+tablet+pc+education&rank=1.
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Affiliation(s)
- Hendrik Suhling
- Dept. of Respiratory Medicine, Hannover Medical School, Hannover, Germany
- * E-mail:
| | - Jessica Rademacher
- Dept. of Respiratory Medicine, Hannover Medical School, Hannover, Germany
| | - Imke Zinowsky
- Dept. of Respiratory Medicine, Hannover Medical School, Hannover, Germany
| | - Jan Fuge
- Dept. of Respiratory Medicine, Hannover Medical School, Hannover, Germany
| | - Mark Greer
- Dept. of Respiratory Medicine, Hannover Medical School, Hannover, Germany
| | - Gregor Warnecke
- Dept. of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany
| | | | - Anna Bertram
- Dept. of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany
| | - Axel Haverich
- Dept. of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany
| | - Tobias Welte
- Dept. of Respiratory Medicine, Hannover Medical School, Hannover, Germany
| | - Jens Gottlieb
- Dept. of Respiratory Medicine, Hannover Medical School, Hannover, Germany
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