Weinhandl Eric D, Gilbertson David T, Collins Allan J, Foley Robert N
Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, MN, USA.
Pharmacoepidemiol Drug Saf. 2014 Oct;23(10):1003-11. doi: 10.1002/pds.3655. Epub 2014 Jun 6.
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.
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.
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.
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.
聚乙二醇化促红细胞生成素（培加尼肽）是一种长效促红细胞生成剂，2013年2月，在有报告称接受首剂治疗的透析患者出现严重且有时致命的过敏反应后，该药物被召回。我们评估了接受培加尼肽治疗的患者与匹配的接受促红细胞生成素α治疗的患者的相对死亡风险和发病风险。
从2012年和2013年付费医疗保险理赔的标准化提取物中，我们识别出在2012年7月1日至2013年2月28日期间接受培加尼肽或促红细胞生成素治疗的透析患者。对于每一位接受培加尼肽治疗的患者，我们通过倾向评分匹配确定两名接受促红细胞生成素治疗的对照患者。在首次使用培加尼肽剂量或参照促红细胞生成素剂量后的2天内，对患者进行随访，观察因心血管疾病或症状导致的死亡或住院情况（复合事件）、全因住院情况以及急诊室护理情况。
我们识别出15633例接受培加尼肽治疗的患者和31266例匹配的接受促红细胞生成素治疗的对照患者。在给药当天，培加尼肽组发生19例复合事件（发生率为0.12%），促红细胞生成素组发生14例（0.04%）；风险比为2.7（95%置信区间为1.4 - 5.4）。在随后的第1天和第2天进行随访时，风险比分别为1.6（1.0 - 2.4）和1.5（1.1 - 2.0）。在给药当天既未接受静脉抗生素治疗也未接受静脉铁剂治疗的血液透析患者中，相应的风险比更大。给药当天及之后，全因住院和急诊室护理的风险比均超过1。
与促红细胞生成素α给药相比，透析患者首次使用培加尼肽与因心血管疾病或症状导致的死亡或住院风险升高急性相关。
