Public Release:  Cleveland Clinic research shows anemia drug does not improve health of anemic heart failure patients

Phase 3 findings published in NEJM provide answers about treatment with darbepoetin alfa

Cleveland Clinic

EMBARGOED UNTIL 7:45 PM ET, Sunday, March 10, 2013, Cleveland: Researchers from Cleveland Clinic and Sweden-based Sahlgrenska University Hospital have found that a commonly used drug to treat anemia in heart failure patients -darbepoetin alfa - does not improve patients' health, nor does it reduce their risk of death from heart failure.

Results of the international study were presented at the American College of Cardiology's annual meeting in San Francisco on March 10 and published simultaneously online by the New England Journal of Medicine.

Initiated in 2006, the RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) trial involved 2,278 anemic heart failure patients at 453 sites in 33 countries. Patients were randomly given either darbepoetin alfa or placebo. In the darbepoetin alfa group, 50.7 percent of the patients experienced death from any cause or hospitalization for worsening heart failure. In the placebo group, 49.5 percent of the patients experienced similar clinical outcomes. The trial was funded by Amgen, the maker of darbepoetin alfa (trade name: Aranesp).

"This landmark study provides answers to caregivers who treat patients with heart failure complicated by anemia," said James Young, M.D., cardiologist and Chair of the Cleveland Clinic Endocrinology & Metabolism Institute, and co-investigator of the RED-HF trial. "Our findings do not support the use of darbepoetin alfa to treat anemic heart failure patients."

Anemia, the lack of red blood cells, is a common and serious problem in people who suffer from heart failure. It can lead to worse quality of life, higher rates of hospitalization and death. Treatment options have focused on correcting anemia with the use of intravenous iron or drugs that stimulate red blood cells.

"The benefits of erythropoietin-stimulating agents (ESAs) such as darbepoetin alfa to treat patients with heart failure and anemia have been questioned due to contradictory research findings," said Karl Swedberg, M.D., Ph.D., a senior professor at the Sweden-based Department of Medicine, Sahlgrenska University Hospital and co-investigator of the RED-HF trial. "Our study results show that the use of darbepoetin alfa to stimulate the production of red blood cells is an ineffective treatment for patients with heart failure and anemia."

According to the study, researchers found that darbepoetin alfa treatment led to an early and sustained increase in hemoglobin compared with placebo. However, darbepoetin alfa treatment did not reduce the risk of death from any cause or hospitalization from heart failure. Findings suggest that hemoglobin is a marker of poor prognosis in heart failure, rather than a therapeutic target. There were no new safety findings identified in the study. However, researchers observed an increased risk of thrombosis in the darbepoetin alfa group.

Researchers note that further research is needed to identify treatment options for this patient population.

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About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, eight community hospitals and 18 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and, currently under construction, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 167,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at http://www.clevelandclinic.org. Follow us at http://www.twitter.com/ClevelandClinic.

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Contacts:
Andrea Pacetti, 216.316.3040, pacetta@ccf.org
Caroline Auger, 216.296.6012, augerc@ccf.org

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