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Increased risk of stroke with darbepoetin alfa in anaemic heart failure patients with diabetes and chronic kidney disease.
- Source :
- European Journal of Heart Failure; Nov2015, Vol. 17 Issue 11, p1201-1207, 7p, 4 Charts, 2 Graphs
- Publication Year :
- 2015
-
Abstract
- <bold>Aims: </bold>The use of an erythropoesis-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 epidemiological data suggesting the contrary. However, this association has not been evaluated in another randomized, placebo-controlled trial.<bold>Methods and Results: </bold>Reduction of Events by Darbepoetin Alfa in Heart Failure (RED-HF) was a randomized placebo-controlled trial of DA in 2278 patients with systolic heart failure and anaemia, enrolled from 2006 to 2012 and followed for a median of 28 months. Within RED-HF, 816 patients had diabetes mellitus and chronic kidney disease [estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m(2) ] and met inclusion criteria for TREAT. TREAT-like RED-HF patient data were analysed alone and combined at the patient level with the 4038 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 = 4854) confirmed a nearly two-fold increase in stroke risk [hazard ratio (HR) 1.94, 95% confidence interval (CI) 1.43-2.63] and an overall neutral effect on mortality (HR 1.00, 95% CI 0.89-1.12) of raising haemoglobin with DA.<bold>Conclusion: </bold>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. [ABSTRACT FROM AUTHOR]
- Subjects :
- STROKE
DARBEPOETIN alfa
ANEMIA treatment
HEART failure
DIABETES
CHRONIC kidney failure
DRUG efficacy
RANDOMIZED controlled trials
TYPE 2 diabetes diagnosis
CHRONIC kidney failure complications
TYPE 2 diabetes complications
STROKE prevention
ANEMIA
COMPARATIVE studies
GLOMERULAR filtration rate
HEMATOPOIETIC agents
RESEARCH methodology
MEDICAL cooperation
HEALTH outcome assessment
RESEARCH
RESEARCH funding
RISK assessment
STATISTICAL sampling
STATISTICS
EVALUATION research
DISEASE complications
DIAGNOSIS
Subjects
Details
- Language :
- English
- ISSN :
- 13889842
- Volume :
- 17
- Issue :
- 11
- Database :
- Complementary Index
- Journal :
- European Journal of Heart Failure
- Publication Type :
- Academic Journal
- Accession number :
- 111093825
- Full Text :
- https://doi.org/10.1002/ejhf.412