For patients with mild-to-moderate anemia, treatment ups risk of thromboembolic events
MONDAY, March 11 (HealthDay News) -- For patients with systolic heart failure and mild-to-moderate anemia, treatment of anemia with darbepoetin alfa is not associated with improved clinical outcomes, according to a study published online March 10 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American College of Cardiology, held from March 9 to 11 in San Francisco.
Karl Swedberg, M.D., Ph.D., from the University of Gothenburg in Sweden, and colleagues conducted a randomized trial involving 2,278 patients with systolic heart failure and mild-to-moderate anemia who were allocated to receive darbepoetin alfa (1,136 patients) or placebo (1,142 patients).
The researchers found that the primary outcome (composite of death from any cause or hospitalization for worsening heart failure) occurred in 50.7 percent of darbepoetin alfa-treated patients and in 49.5 percent of placebo-treated patients (hazard ratio, 1.01; P = 0.87), with the neutral effect maintained across all prespecified subgroups. No significant difference was seen in any secondary outcomes. There was no significant difference in the incidence of fatal or nonfatal stroke in the darbepoetin alfa versus placebo groups (3.7 versus 2.7 percent). Significantly more thromboembolic adverse events were reported in the darbepoetin alfa group versus the placebo group (13.5 versus 10.0 percent).
"The correction of anemia with the use of darbepoetin alfa did not reduce the rate of death or hospitalization among patients with systolic heart failure who were receiving contemporary treatment," the authors write. "Our findings do not support the use of darbepoetin alfa in patients with systolic heart failure and mild-to-moderate anemia."
The study was funded by Amgen, the manufacturer of darbepoetin alfa.
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