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Kamiya T, Miyake T, Inatomi O, Shimizu T. A Case of Sigmoid Colon Perforation Associated with Sodium Zirconium Cyclosilicate in a Patient with Advanced Rectal Cancer. Surg Case Rep 2025; 11:24-0123. [PMID: 40115217 PMCID: PMC11925643 DOI: 10.70352/scrj.cr.24-0123] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2024] [Accepted: 02/09/2025] [Indexed: 03/23/2025] Open
Abstract
INTRODUCTION Sodium zirconium cyclosilicate (SZC) binds with potassium in the gastrointestinal tract and increases fecal potassium excretion. Since SZC is a novel and non-swelling drug, the risk of intestinal perforation is not mentioned in the package insert. We hereby report the case of sigmoid colon perforation caused by hard stools and severe hypokalemia in a patient suffering from advanced rectal cancer, who was taking SZC. CASE PRESENTATION A woman in her 80s with a history of primary biliary cirrhosis and decompensated cirrhosis accompanied by hyperkalemia was administered SZC. The patient was rushed to the hospital on the 23rd day following the commencement of SZC, complaining of abdominal pain and nausea. She suffered from sigmoid colon perforation. Hartmann's operation with drainage was performed. SZC was discontinued after admission, following which the serum potassium levels normalized. Despite the diagnosis of advanced rectal cancer during her hospital stay, the curative operation and stoma closure were judged to be inoperable because of her physical condition. CONCLUSIONS SZC is said to be associated with a lower risk of intestinal perforation compared with other similar drugs; however, in patients with certain conditions, such as intestinal obstruction or transit disorder resulting from malignant disease, adhesion, and inflammatory diseases, the accumulation of SZC in the intestinal lumen might increase the risk of perforation.
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Affiliation(s)
- Takaki Kamiya
- Department of Pharmacy, Shiga University of Medical Science Hospital, Otsu, Shiga, Japan
- Medical Safety Section, Shiga University of Medical Science Hospital, Otsu, Shiga, Japan
| | - Toru Miyake
- Department of Surgery, Shiga University of Medical Science, Otsu, Shiga, Japan
| | - Osamu Inatomi
- Department of Gastroenterology, Shiga University of Medical Science, Otsu, Shiga, Japan
| | - Tomoharu Shimizu
- Medical Safety Section, Shiga University of Medical Science Hospital, Otsu, Shiga, Japan
- Department of Surgery, Shiga University of Medical Science, Otsu, Shiga, Japan
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Aver GP, Ribeiro GF, Ballotin VR, Santos FSD, Bigarella LG, Riva F, Brambilla E, Soldera J. Comprehensive analysis of sodium polystyrene sulfonate-induced colitis: A systematic review. World J Meta-Anal 2023; 11:351-367. [DOI: 10.13105/wjma.v11.i7.351] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/08/2023] [Revised: 10/04/2023] [Accepted: 10/23/2023] [Indexed: 12/14/2023] Open
Abstract
BACKGROUND Sodium polystyrene sulfonate (SPS) is commonly prescribed for the management of hyperkalemia, a critical electrolyte imbalance contributing to over 800000 annual visits to emergency departments.
AIM To conduct a systematic review of documented cases of SPS-induced colitis and assess its associated prognosis.
METHODS Following the PRISMA-P guidelines, our study employed Medical Subject Headings and Health Sciences Descriptors, skillfully combined using Boolean operators, to conduct comprehensive searches across various electronic databases, including Scopus, Web of Science, MEDLINE (PubMed), BIREME (Biblioteca Regional de Medicina), LILACS (Latin American and Caribbean Health Sciences Literature), SciELO (Scientific Electronic Library Online), Embase, and Opengray.eu. Language criteria were confined to English, Spanish, and Portuguese, with no limitations on the publication date. Additionally, we manually scrutinized the reference lists of retrieved studies. To present our findings, we utilized simple descriptive analysis.
RESULTS Our search strategy yielded a total of 442 references. After rigorous evaluation, we included 51 references, encompassing 59 documented cases of colitis. Predominant clinical presentations included abdominal pain, observed in 35 (60.3%) cases, and bloating, reported in 18 (31%) cases. The most frequently affected sites of inflammation were the cecum, rectum, and small intestine, accounting for 31%, 25.8%, and 22.4% of cases, respectively. Colonoscopy findings were described in 28 (48.2%) cases, and 29 (50%) of patients required surgical intervention. Among the subset of patients for whom outcome data was available, 39 (67.2%) experienced favorable outcomes, while 12 (20.6%) unfortunately succumbed to the condition. The mean time required for resolution was 36.7 d, with a range spanning from 1 to 120 d.
CONCLUSION SPS demonstrates the capacity to effectively lower serum potassium levels within 24 h. However, this benefit is not without the risk of bowel injury. Our study highlights the absence of high-quality data pertaining to the incidence of adverse events associated with SPS usage, making it challenging to determine whether the potential risks outweigh the benefits. However, a significant mortality rate related to SPS-induced colitis was noted. Future investigations should prioritize randomized controlled trials with a sufficiently large patient cohort to ascertain the true utility and safety profile of this medication.
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Affiliation(s)
- Gabriel Peixoto Aver
- School of Medicine, Universidade de Caxias do Sul, Caxias do Sul 95070-560, Brazil
| | | | | | | | | | - Floriano Riva
- Department of Pathology, CPM Laboratório de Patologia, Caxias do Sul 95084-900, RS, Brazil
| | - Eduardo Brambilla
- Clinical Gastroenterology, Universidade de Caxias do Sul, Caxias do Sul 95070-560, RS, Brazil
| | - Jonathan Soldera
- Acute Medicine and Gastroenterology, University of South Wales, Cardiff CF37 1DL, United Kingdom
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dos Santos FS, Aver GP, Paim TV, Riva F, Brambilla E, Soldera J. Sodium-Polystyrene Sulfonate-Induced Colitis. GE PORTUGUESE JOURNAL OF GASTROENTEROLOGY 2023; 30:153-155. [PMID: 37008520 PMCID: PMC10050855 DOI: 10.1159/000521195] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/20/2021] [Accepted: 10/28/2021] [Indexed: 11/19/2022]
Affiliation(s)
| | | | - Thais Vieira Paim
- School of Medicine, Universidade de Caxias do Sul, Caxias do Sul, Brazil
| | - Floriano Riva
- Centro de Patologia Médica (CPM), Caxias do Sul, Brazil
| | - Eduardo Brambilla
- Clinical Gastroenterology, School of Medicine, Universidade de Caxias do Sul, Caxias do Sul, Brazil
- Post-Graduate Program, Surgery, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil
| | - Jonathan Soldera
- Clinical Gastroenterology, School of Medicine, Universidade de Caxias do Sul, Caxias do Sul, Brazil
- Post-Graduate Program, Pathology, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil
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Kumaresan M, Arun RS, Damle A, Parthasarathy R, Matthew M, Abraham G. Crystal-Induced Lower GI Necrosis in a Posttransplant Recipient with Diverticular Disease. Indian J Nephrol 2023; 33:54-56. [PMID: 37197038 PMCID: PMC10185010 DOI: 10.4103/ijn.ijn_564_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: 12/15/2020] [Revised: 02/28/2021] [Accepted: 09/14/2021] [Indexed: 12/28/2022] Open
Abstract
We report the case of a 67-year-old male kidney transplant recipient for 12 years with sodium polystyrene sulfonate crystal-induced ileocecal colitis. He had adult polycystic kidney disease with associated colonic diverticular disease. Here, we describe how a potentially fatal complication of colonic perforation was averted with appropriate investigations and management.
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Affiliation(s)
- Maithrayie Kumaresan
- Department of Nephrology, Madras Medical Mission Hospital, Chennai, Tamil Nadu, India
| | - R. S Arun
- Department of Nephrology, Madras Medical Mission Hospital, Chennai, Tamil Nadu, India
| | - Aditi Damle
- Department of Nephrology, Madras Medical Mission Hospital, Chennai, Tamil Nadu, India
| | | | - Milly Matthew
- Department of Nephrology, Madras Medical Mission Hospital, Chennai, Tamil Nadu, India
| | - Gerogi Abraham
- Department of Nephrology, Madras Medical Mission Hospital, Chennai, Tamil Nadu, India
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Lower Gastrointestinal Bleeding Associated With Sodium Polystyrene Sulfonate Use. ACG Case Rep J 2021; 8:e00585. [PMID: 33997091 PMCID: PMC8116012 DOI: 10.14309/crj.0000000000000585] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/24/2020] [Accepted: 12/03/2020] [Indexed: 11/18/2022] Open
Abstract
Sodium polystyrene sulfonate (kayexalate) is a cation-exchange resin widely used in the management of hyperkalemia. Gastrointestinal adverse events are uncommon; symptoms are nonspecific, and mucosal injury can range from mild ulceration to bowel perforation. An 81-year-old man was admitted because of decompensation of cirrhosis with acute kidney injury and hyperkalemia, treated with sodium polystyrene sulfonate. During admission, he presented multiple episodes of hematochezia, accompanied by tachycardia and hemoglobin drop. Colonoscopy revealed colonic ulceration, and histopathological findings were compatible with ulceration due to kayexalate injury. Despite rare, the widespread use of sodium polystyrene sulfonate puts a large population at risk of serious complications related to its use.
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Wu YH, Chou JW, Lai HC, Su GS, Cheng KS, Chen TW. Adverse Gastrointestinal Effects with Kayexalate or Kalimate: A Comprehensive Review. Clin Exp Gastroenterol 2021; 14:1-18. [PMID: 33469334 PMCID: PMC7810591 DOI: 10.2147/ceg.s278812] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/28/2020] [Accepted: 11/24/2020] [Indexed: 01/13/2023] Open
Abstract
BACKGROUND Patients with hyperkalemia are commonly treated with Kayexalate or Kalimate. Both drugs are associated with some fatal gastrointestinal (GI) adverse events (AEs). AIM To assess the clinical characteristics and outcomes of GI AEs induced by Kayexalate or Kalimate from published case reports. METHODS We conducted a systematic review of case reports of Kayexalate or Kalimate-induced GI AEs, from PubMed, Medline, Cochrane Library, Clinical Key, and Google Scholar databases (1948 to March 31, 2020). We analyzed the clinical characteristics, GI AEs, and risk factors of enrolled patients. RESULTS We identified 41 published articles describing 135 cases of GI AEs induced by Kayexalate (103 cases) or Kalimate (32 cases). The mean age of all patients was 55.5 years. Most patients were male (54.8%). As high as 55.6% preparations were administered with sorbitol whereas 44.4% preparations had no sorbitol. The average time causing GI AEs was 19.8 days. Colon was the most commonly affected site (76.3%). Drug crystals were histopathologically proven in 95.5% of the patients. Meanwhile, mortality was reported in 20.7%. CONCLUSION Kayexalate or Kalimate, without or with sorbitol combination, may be related to fatal GI damage. Uremia, hypertension, and transplantation are predisposing factors. Clinicians should be careful in prescribing Kayexalate or Kalimate to patients.
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Affiliation(s)
- Yi-Hua Wu
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
| | - Jen-Wei Chou
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
- School of Medicine, China Medical University Hospital, Taichung, Taiwan
- Taiwan Society of Inflammatory Bowel Disease, Taipei, Taiwan
- Taiwan Association for the Study of Small Intestinal Diseases, Taoyuan, Taiwan
- Correspondence: Jen-Wei Chou Division of Gastroenterology and Hepatology, Department of Internal Medicine. China Medical University Hospital, No. 2, Yude Road, North District, Taichung40447, TaiwanTel + 886-4-22052121 ext. 2220Fax +886-4-22023119 Email
| | - Hsiang-Chun Lai
- Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan
| | - Gin-Shen Su
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
| | - Ken-Sheng Cheng
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
- School of Medicine, China Medical University Hospital, Taichung, Taiwan
| | - Tsung-Wei Chen
- Department of Pathology, Asia University Hospital, Taichung, Taiwan
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Kim T, de Oliveira Silva Lautenschlager S, Ma Q, Eller K, Pollheimer MJ, Lazarin-Bidóia D, Nakamura CV, Anders HJ, Steiger S. Drug Crystal-Related Gastrointestinal Complications Involve Crystal-Induced Release of Neutrophil and Monocyte Extracellular Traps. Cells 2020; 9:cells9112481. [PMID: 33203124 PMCID: PMC7697008 DOI: 10.3390/cells9112481] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2020] [Revised: 11/05/2020] [Accepted: 11/07/2020] [Indexed: 12/14/2022] Open
Abstract
Ion-exchange resins are commonly used to manage complications of chronic kidney disease, such as hyperphosphatemia, hyperkalemia, and hypercholesterolemia. Occasionally, these drugs can irritate the gastrointestinal lining and cause life-threatening intestinal necrosis. Currently, the pathophysiology of drug crystal-induced intestinal necrosis is not well understood. We hypothesized that crystals of ion-exchange resins like sevelamer, polystyrene sulfonate, and cholestyramine can trigger the formation of neutrophil and monocyte extracellular traps by contributing to intestinal barrier dysfunction. Light and fluorescence microscopy of the colonic resection specimen from a patient with chronic kidney disease revealed severe intestinal necrosis, ulceration, sevelamer crystals, and inflammation upon oral intake of sevelamer, as well as the formation of neutrophil extracellular traps in proximity to small sevelamer crystals. Indeed, drug crystals reduced metabolic activity and induced barrier dysfunction and cell death in human intestinal epithelial cells in vitro. In addition, drug crystals triggered the release of neutrophil and monocyte extracellular traps. Taken together, these data raise the possibility that besides other factors including chronic kidney disease, diabetes mellitus, and hypertension, drug crystals may further amplify a pre-existing barrier dysfunction and necroinflammation in a crescendo of local intestinal necrosis and systemic inflammation/infection, as occasionally observed in patients on ion-exchange resin therapy.
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Affiliation(s)
- Tehyung Kim
- Division of Nephrology, Department of Medicine IV, Ludwig-Maximilians-University Hospital Munich, 80336 Munich, Germany; (T.K.); (Q.M.)
| | | | - Qiuyue Ma
- Division of Nephrology, Department of Medicine IV, Ludwig-Maximilians-University Hospital Munich, 80336 Munich, Germany; (T.K.); (Q.M.)
| | - Kathrin Eller
- Division of Nephrology, Department of Internal Medicine, Medical University Graz, 8036 Graz, Austria;
| | - Marion Julia Pollheimer
- Diagnostic and Research Institute of Pathology, Medical University of Graz, 8010 Graz, Austria;
| | - Danielle Lazarin-Bidóia
- Postgraduate Program in Pharmaceutical Sciences, State University of Maringá, Maringá, Paraná 5790, Brazil; (S.d.O.S.L.); (D.L.-B.); (C.V.N.)
| | - Celso Vataru Nakamura
- Postgraduate Program in Pharmaceutical Sciences, State University of Maringá, Maringá, Paraná 5790, Brazil; (S.d.O.S.L.); (D.L.-B.); (C.V.N.)
| | - Hans-Joachim Anders
- Division of Nephrology, Department of Medicine IV, Ludwig-Maximilians-University Hospital Munich, 80336 Munich, Germany; (T.K.); (Q.M.)
- Correspondence: (H.-J.A.); (S.S.); Tel.: +49-89-4400-53583 (H.-J.A.); +49-89-4400-52129 (S.S.)
| | - Stefanie Steiger
- Division of Nephrology, Department of Medicine IV, Ludwig-Maximilians-University Hospital Munich, 80336 Munich, Germany; (T.K.); (Q.M.)
- Correspondence: (H.-J.A.); (S.S.); Tel.: +49-89-4400-53583 (H.-J.A.); +49-89-4400-52129 (S.S.)
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Laureati P, Xu Y, Trevisan M, Schalin L, Mariani I, Bellocco R, Sood MM, Barany P, Sjölander A, Evans M, Carrero JJ. Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study. Nephrol Dial Transplant 2020; 35:1518-1526. [PMID: 31377791 PMCID: PMC7473802 DOI: 10.1093/ndt/gfz150] [Citation(s) in RCA: 66] [Impact Index Per Article: 13.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2019] [Accepted: 06/27/2019] [Indexed: 11/26/2022] Open
Abstract
BACKGROUND Despite long-standing clinical use of sodium polystyrene sulphonate (SPS) for hyperkalaemia management in chronic kidney disease (CKD), its safety profile remains poorly investigated. METHODS We undertook an observational analysis of nephrology-referred adults with incident CKD Stage 4+ in Sweden during 2006-16 and with no previous SPS use. We studied patterns of use and adverse events associated to SPS initiation during follow-up. Patterns of SPS use were defined by chronicity of treatment and by prescribed dose. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) associated with SPS initiation (time-varying exposure) for the risk of severe (intestinal ischaemia, thrombosis or ulceration/perforation) and minor (de novo dispensation of laxatives or anti-diarrheal drugs) gastrointestinal (GI) events. RESULTS Of 19 530 SPS-naïve patients with CKD, 3690 initiated SPS during follow-up. A total of 59% took SPS chronically, with an average of three dispensations/year. The majority (85%) were prescribed lower dosages than specified on the product label. During follow-up, 202 severe and 1149 minor GI events were recorded. SPS initiation was associated with a higher incidence of severe adverse events [adjusted HR 1.25 95% CI 1.05-1.49)], particularly in those receiving per label doses [1.54 (1.09-2.17)] and mainly attributed to ulcers and perforations. SPS initiation was also associated with higher incidence of minor GI events [adjusted HR 1.11 (95% CI 1.03-1.19)], regardless of dose, and mainly accounted for by de novo dispensation of laxatives. CONCLUSIONS Initiation of SPS in patients with advanced CKD is associated with a higher risk of severe GI complications as well as the initiation of GI-related medications, particularly when prescribed at per label doses.
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Affiliation(s)
- Paola Laureati
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
- University of Milano-Bicocca, Milan, Italy
| | - Yang Xu
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
| | - Marco Trevisan
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
| | | | - Illaria Mariani
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
- University of Milano-Bicocca, Milan, Italy
| | - Rino Bellocco
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
- University of Milano-Bicocca, Milan, Italy
| | - Manish M Sood
- Department of Medicine, University of Ottawa, Ottawa, ON, Canada
| | - Peter Barany
- Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden
| | - Arvid Sjölander
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
| | - Marie Evans
- Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden
| | - Juan J Carrero
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
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Widén J, Ivarsson M, Schalin L, Vrouchou P, Schwenkglenks M, Heimbürger O, Ademi Z, Sutherland CS. Cost-Effectiveness Analysis of Patiromer in Combination with Renin-Angiotensin-Aldosterone System Inhibitors for Chronic Kidney Disease in Sweden. PHARMACOECONOMICS 2020; 38:747-764. [PMID: 32239480 DOI: 10.1007/s40273-020-00902-w] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/11/2023]
Abstract
OBJECTIVES Patients with chronic kidney disease (CKD) are commonly treated with renin-angiotensin-aldosterone system inhibitors (RAASi) in order to delay progression of renal disease. However, research has shown that RAASi in CKD patients increases hyperkalaemia (HK) prevalence, which leads to RAASi discontinuation or dose reduction with the loss of benefits on the kidney. Patiromer is a novel therapy for HK treatment and may enable patients to remain on their RAASi regimen. This study aimed to assess the cost-effectiveness of patiromer from a Swedish healthcare perspective. METHODS A Markov model was developed to evaluate the economic outcomes of patiromer versus no patiromer in HK patients with stage 3-4 CKD taking RAASi. The model consisted of six health states reflecting disease progression and hospitalisations. The analysis mainly considered clinical data from the OPAL-HK trial and national costs. The main outcomes of interest were incremental costs (euro [EUR] 2016) and quality-adjusted life years (QALYs), discounted at 3%, and the incremental cost-effectiveness ratio (ICER). Extensive uncertainty analyses were performed. RESULTS In comparison to no patiromer, a patiromer patient gained 0.14 QALYs and an incremental cost of EUR 6109 (Swedish krona [SEK] 57,850), yielding an ICER of EUR 43,307 (SEK 410,072)/QALY gained. The results were robust to a range of sensitivity analyses. At a willingness-to-pay threshold of EUR 52,804 (SEK 500,000)/QALY, patiromer had a 50% chance of being cost-effective. CONCLUSIONS The results indicate that patiromer may demonstrate value for money in Swedish patients with stage 3-4 CKD, by enabling RAASi treatment. However, there is a considerable degree of uncertainty.
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Affiliation(s)
| | | | | | | | | | - Olof Heimbürger
- Patient Area Endocrinology and Renal Medicine, Karolinska University Hospital, Stockholm, Sweden
- CLINTEC, Karolinska Institutet, Stockholm, Sweden
| | - Zanfina Ademi
- Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland
- School of Public Health and Preventive Medicine (SPHPM), Monash University, Melbourne, Australia
| | - C Simone Sutherland
- Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland
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