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.