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RANDOMIZED CONTROLLED TRIAL
Steven Fishbane, Brigitte Schiller, Francesco Locatelli, Adrian C Covic, Robert Provenzano, Andrzej Wiecek, Nathan W Levin, Mark Kaplan, Iain C Macdougall, Carol Francisco, Martha R Mayo, Krishna R Polu, Anne-Marie Duliege, Anatole Besarab
BACKGROUND: Peginesatide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), is a potential therapy for anemia in patients with advanced chronic kidney disease. METHODS: We conducted two randomized, controlled, open-label studies (EMERALD 1 and EMERALD 2) involving patients undergoing hemodialysis. Cardiovascular safety was evaluated by analysis of an adjudicated composite safety end point--death from any cause, stroke, myocardial infarction, or serious adverse events of congestive heart failure, unstable angina, or arrhythmia--with the use of pooled data from the two EMERALD studies and two studies involving patients not undergoing dialysis...
January 24, 2013: New England Journal of Medicine
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