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Pharmacoepidemiol Drug Saf. 2014 Oct;23(10):1003-11. doi: 10.1002/pds.3655. Epub 2014 Jun 6.

Relative safety of peginesatide and epoetin alfa.

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  • 1Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, MN, USA.

Abstract

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.

KEYWORDS:

Medicare; claims; dialysis; erythropoiesis-stimulating agent; matching; pharmacoepidemiology

Comment in

PMID:
24905967
DOI:
10.1002/pds.3655
[PubMed - indexed for MEDLINE]
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