TY - JOUR T1 - Longer-term outcomes of darbepoetin alfa versus epoetin alfa in patients with ESRD initiating hemodialysis: a quasi-experimental cohort study. AU - Winkelmayer,Wolfgang C, AU - Chang,Tara I, AU - Mitani,Aya A, AU - Wilhelm-Leen,Emilee R, AU - Ding,Victoria, AU - Chertow,Glenn M, AU - Brookhart,M Alan, AU - Goldstein,Benjamin A, Y1 - 2015/05/02/ PY - 2014/12/22/received PY - 2015/02/27/accepted PY - 2015/5/7/entrez PY - 2015/5/7/pubmed PY - 2015/9/12/medline KW - Mortality KW - cardiovascular KW - darbepoetin alfa (DPO) KW - epoetin alfa (EPO) KW - erythropoiesis-stimulating agent (ESA) KW - hemodialysis KW - myocardial infarction KW - recombinant erythropoietin KW - renal replacement therapy (RRT) KW - safety KW - stroke SP - 106 EP - 13 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 66 IS - 1 N2 - BACKGROUND: Adequately powered studies directly comparing hard clinical outcomes of darbepoetin alfa (DPO) versus epoetin alfa (EPO) in patients undergoing dialysis are lacking. STUDY DESIGN: Observational, registry-based, retrospective cohort study; we mimicked a cluster-randomized trial by comparing mortality and cardiovascular events in US patients initiating hemodialysis therapy in facilities (almost) exclusively using DPO versus EPO. SETTING & PARTICIPANTS: Nonchain US hemodialysis facilities; each facility switching from EPO to DPO (2003-2010) was matched for location, profit status, and facility type with one EPO facility. Patients subsequently initiating hemodialysis therapy in these facilities were assigned their facility-level exposure. INTERVENTION: DPO versus EPO. OUTCOMES: All-cause mortality, cardiovascular mortality; composite of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke. MEASUREMENTS: Unadjusted and adjusted HRs from Cox proportional hazards regression models. RESULTS: Of 508 dialysis facilities that switched to DPO, 492 were matched with a similar EPO facility; 19,932 (DPO: 9,465 [47.5%]; EPO: 10,467 [52.5%]) incident hemodialysis patients were followed up for 21,918 person-years during which 5,550 deaths occurred. Almost all baseline characteristics were tightly balanced. The demographics-adjusted mortality HR for DPO (vs EPO) was 1.06 (95% CI, 1.00-1.13) and was materially unchanged after adjustment for all other baseline characteristics (HR, 1.05; 95% CI, 0.99-1.12). Cardiovascular mortality did not differ between groups (HR, 1.05; 95% CI, 0.94-1.16). Nonfatal outcomes were evaluated among 9,455 patients with fee-for-service Medicare: 4,542 (48.0%) in DPO and 4,913 (52.0%) in EPO facilities. During 10,457 and 10,363 person-years, 248 and 372 events were recorded, respectively, for strokes and MIs. We found no differences in adjusted stroke or MI rates or their composite with cardiovascular death (HR, 1.10; 95% CI, 0.96-1.25). LIMITATIONS: Nonrandom treatment assignment, potential residual confounding. CONCLUSIONS: In incident hemodialysis patients, mortality and cardiovascular event rates did not differ between patients treated at facilities predominantly using DPO versus EPO. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/25943715/Longer_term_outcomes_of_darbepoetin_alfa_versus_epoetin_alfa_in_patients_with_ESRD_initiating_hemodialysis:_a_quasi_experimental_cohort_study_ DB - PRIME DP - Unbound Medicine ER -