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Longer-term outcomes of darbepoetin alfa versus epoetin alfa in patients with ESRD initiating hemodialysis: a quasi-experimental cohort study.
- Source :
-
American journal of kidney diseases : the official journal of the National Kidney Foundation [Am J Kidney Dis] 2015 Jul; Vol. 66 (1), pp. 106-13. Date of Electronic Publication: 2015 May 02. - Publication Year :
- 2015
-
Abstract
- Background: Adequately powered studies directly comparing hard clinical outcomes of darbepoetin alfa (DPO) versus epoetin alfa (EPO) in patients undergoing dialysis are lacking.<br />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.<br />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.<br />Intervention: DPO versus EPO.<br />Outcomes: All-cause mortality, cardiovascular mortality; composite of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke.<br />Measurements: Unadjusted and adjusted HRs from Cox proportional hazards regression models.<br />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).<br />Limitations: Nonrandom treatment assignment, potential residual confounding.<br />Conclusions: In incident hemodialysis patients, mortality and cardiovascular event rates did not differ between patients treated at facilities predominantly using DPO versus EPO.<br /> (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Ambulatory Care Facilities
Anemia drug therapy
Anemia etiology
Cardiovascular Diseases mortality
Cause of Death
Comorbidity
Darbepoetin alfa
Epoetin Alfa
Erythropoietin adverse effects
Erythropoietin pharmacokinetics
Erythropoietin therapeutic use
Female
Hemodialysis Units, Hospital
Humans
Kidney Failure, Chronic complications
Kidney Failure, Chronic mortality
Kidney Failure, Chronic therapy
Male
Middle Aged
Myocardial Infarction epidemiology
Proportional Hazards Models
Recombinant Proteins therapeutic use
Registries
Renal Dialysis
Renal Insufficiency, Chronic complications
Retrospective Studies
Stroke epidemiology
Treatment Outcome
United States epidemiology
Erythropoietin analogs & derivatives
Hematinics therapeutic use
Renal Insufficiency, Chronic mortality
Subjects
Details
- Language :
- English
- ISSN :
- 1523-6838
- Volume :
- 66
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- American journal of kidney diseases : the official journal of the National Kidney Foundation
- Publication Type :
- Academic Journal
- Accession number :
- 25943715
- Full Text :
- https://doi.org/10.1053/j.ajkd.2015.02.339