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Deprecated: Implicit conversion from float 265.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Eur+J+Heart+Fail 2015 ; 17 (11): 1201-7 Nephropedia Template TP
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Increased Risk of Stroke with Darbepoetin Alfa in Anaemic Heart Failure Patients with Diabetes and Chronic Kidney Disease #MMPMID26423928
Bello NA; Lewis EF; Desai AS; Anand IS; Krum H; McMurray JJ; Olson K; Solomon SD; Swedberg K; van Veldhuisen DJ; Young JB; Pfeffer MA
Eur J Heart Fail 2015[Nov]; 17 (11): 1201-7 PMID26423928show ga
Aims: The use of an erythropoetic stimulating agent, darbepoetin alfa (DA), to treat anaemia in patients with diabetes mellitus and chronic kidney disease was associated with a heightened risk of stroke and neutral efficacy in The Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), despite epidemiologic data suggesting the contrary. However, this association has not been evaluated in another randomized, placebo controlled trial. Methods and results: Reduction of Events by Darbepoetin Alfa in Heart Failure (RED-HF) was a randomized placebo controlled trial of DA in 2,278 patients with systolic heart failure and anaemia, enrolled from 2006-2012 and followed for a median of 28 months. Within RED-HF, 816 patients had diabetes mellitus and chronic kidney disease (eGFR 20-60 mL/min/1.73 m2) and met inclusion criteria for TREAT. TREAT-like RED-HF patient data was analyzed alone and combined at the patient level with the 4,038 TREAT patients. In RED-HF the annualized event rate of stroke was 2.3 in patients on DA and 1.1 in patients randomized to placebo (p=0.051). Analysis of the combined group (n=4,854) confirmed a nearly two-fold increase in stroke risk [HR 1.94, (95% CI 1.43-2.63)] and an overall neutral effect on mortality [1.00 (0.89-1.12)] of raising hemoglobin with DA. Conclusion: The placebo controlled cohort of heart failure patients with anaemia, diabetes mellitus, and chronic kidney disease from RED-HF provides confirmation of the increased stroke risk associated with DA use identified in TREAT.