title: Relative safety of peginesatide and epoetin alfa.
abstract: OBJECTIVE
  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.
authors.affiliation: Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, MN, USA.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Weinhandl
authors.forename: David T
authors.initials: DT
authors.lastname: Gilbertson
authors.forename: Allan J
authors.initials: AJ
authors.lastname: Collins
authors.forename: Robert N
authors.initials: RN
authors.lastname: Foley
mesh_terms: D000740:Anemia / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D016208:Databases, Factual; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006435:Renal Dialysis / Q000009:adverse effects / Q000706:statistics & numerical data
chemical_list: D006397:Hematinics; D010455:Peptides; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa; C556270:peginesatide
keywords: Medicare; claims; dialysis; erythropoiesis-stimulating agent; matching; pharmacoepidemiology