Anemia and heart failure: Improvement in outcomes tied to increase in hemoglobin level

November 14, 2006

A rise in hemoglobin of at least 1 g/dL appears necessary to affect the course of heart failure in patients with symptomatic heart failure and anemia, according to a post hoc analysis of STAMINA-HeFT (Studies of Anemia in Heart Failure-Heart Failure Trial).

A rise in hemoglobin of at least 1 g/dL appears necessary to affect the course of heart failure in patients with symptomatic heart failure and anemia, according to a post hoc analysis of STAMINA-HeFT (Studies of Anemia in Heart Failure-Heart Failure Trial).

STAMINA-HeFT was a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of treating anemia with twice-weekly darbepoetin alfa in anemic heart failure patients. In the study, 319 patients with New York Heart Association class II to IV heart failure who had hemoglobin (Hb) levels of 9.0 to 12.5 g/dL were randomized to placebo or darbepoetin alfa for 1 year to achieve a target Hb of 14.0 g/dL.

The mean improvement in Hb level in the patients assigned to darbepoetin alfa was 1.8 g/dL. The main results demonstrated a trend toward improvement in exercise duration (the primary end point) with darbepoetin alfa that did not reach statistical significance. The new analysis included only the darbepoetin alfa-treated patients in STAMINA-HeFT, and compared outcomes among those who achieved at least a 1 g/dL increase in Hb after Week 17 and those who failed to achieve at least a 1 g/dL increase in Hb.

The adjusted mean change in exercise duration from baseline to 6 months was 66.2 seconds in the patients with ≥1 g/dL increase in Hb, compared with an increase of 14.7 seconds in those with a <1.0 g/dL increase in Hb (P =.037), reported lead investigator Jalal Ghali, MD, from Wayne State University Health Center in Detroit, Mich.

"The findings suggest that an increase of 1.0 g/dL or more in hemoglobin is required to achieve benefit," Dr. Ghali said.

Clinical outcomes were also significantly improved in the patients who achieved at least a 1 g/dL increase in Hb. In this group, there was a 71% reduction in the composite of all-cause mortality or heart failure-related hospitalization (P =.001), a 75% decrease in heart failure-related hospitalization alone (P =.002), and a 79% reduction in all-cause mortality (P =.004) relative to the patients with <1 g/dL improvement in Hb concentration.

There were fewer serious adverse events in the patients who achieved ≥1 g/dL increase in Hb.