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Relative safety of peginesatide and epoetin alfa
Author(s) -
Weinhandl Eric D.,
Gilbertson David T.,
Collins Allan J.,
Foley Robert N.
Publication year - 2014
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.3655
Subject(s) - medicine , epoetin alfa , hazard ratio , confidence interval , relative risk , hemodialysis , dialysis , anemia
Purpose Peginesatide, a long‐acting erythropoiesis‐stimulating agent, was recalled in February 2013 following reports of serious and sometimes fatal hypersensitivity reactions in dialysis patients who received a first dose. We assessed the relative risks of mortality and morbidity in peginesatide‐treated and matched epoetin alfa‐treated patients. Methods From standardized extracts of paid Medicare claims in 2012 and 2013, we identified dialysis patients treated with peginesatide or epoetin between 1 July 2012 and 28 February 2013. For each peginesatide‐treated patient, we identified with propensity score matching two epoetin‐treated control patients. Patients were followed for up to 2 days after the first peginesatide dose or the referent epoetin dose for death or hospitalization as a result of cardiovascular morbidity or symptoms (composite event), all‐cause hospitalization, and emergency room care. Results We identified 15 633 peginesatide‐treated patients and 31 266 matched epoetin‐treated controls. On the day of dose administration, 19 composite events occurred with peginesatide (incidence, 0.12%) and 14 with epoetin (0.04%); the hazard ratio was 2.7 (95% confidence interval, 1.4–5.4). With follow‐up for 1 and 2 subsequent days, hazard ratios were 1.6 (1.0–2.4) and 1.5 (1.1–2.0), respectively. Corresponding hazard ratios were larger among hemodialysis patients with neither intravenous antibiotic nor intravenous iron exposure on the day of dose administration. Hazard ratios for all‐cause hospitalization and emergency room care exceeded 1 on and after the day of dose administration. Conclusions Relative to administration of epoetin alfa, first administration of peginesatide in dialysis patients was acutely associated with higher risk of death or hospitalization as a result of cardiovascular morbidity or symptoms. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.