American journal of kidney diseases : the official journal of the National Kidney Foundation · 2015
Longer-term outcomes of darbepoetin alfa versus epoetin alfa in patients with ESRD initiating hemodialysis: a quasi-experimental cohort study.
Сравнительное исследованиеСтатьяНаблюдательное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Winkelmayer Wolfgang C, Chang Tara I, Mitani Aya A, Wilhelm-Leen Emilee R, Ding Victoria, Chertow Glenn M, Brookhart M Alan, Goldstein Benjamin A
Аннотация
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.
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.
Предметные рубрики MeSH
AgedAmbulatory Care FacilitiesAnemiaCardiovascular DiseasesCause of DeathComorbidityDarbepoetin alfaEpoetin AlfaErythropoietinFemaleHematinicsHemodialysis Units, HospitalHumansKidney Failure, ChronicMaleMiddle AgedMyocardial InfarctionProportional Hazards ModelsRecombinant ProteinsRegistriesRenal DialysisRenal Insufficiency, ChronicRetrospective StudiesStrokeTreatment OutcomeUnited States