Intravenous (I.V.) iron treatment with ferric carboxymaltose to reverse iron deficiency can significantly improve symptoms, exercise tolerance and quality of life for chronic heart failure (CHF) patients, researchers said in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.
"Our study shows that treating iron deficiency for 24 weeks with iron in the form of I.V. ferric carboxymaltose safely improves symptoms in patients with chronic heart failure with anemia," said Stefan D. Anker, M.D., Ph.D., Professor of Cardiology and Cachexia Research, Department of Cardiology, Charite Medical School in Berlin, Germany. Anker is lead investigator of the FAIR-HF (Ferinject(R) Assessment in patients with IRon deficiency and chronic Heart Failure) study.
Anker added, "This is the first fully successful phase 3 trial of a drug for chronic heart failure to improve symptoms in many years. Besides symptoms, our treatment also improved functional exercise capacity as measured by the 6-minute walking test and quality of life and it was very well tolerated."
The researchers studied 459 heart failure patients with iron deficiency in 75 study sites, mainly in Europe and Argentina. Researchers randomized two-thirds of the patients to receive weekly I.V. injections of iron until the iron deficiency was reversed, with monthly treatment thereafter. The other one-third received a placebo (saline).
The group treated with I.V. iron showed significant improvements in both of the study's two primary endpoints: 1) self-reported Patient Global Assessment (PGA) score after 24 weeks (P<0.0001) and 2) a measure of CHF severity called New York Heart Association (NYHA) class (P<0.0001). To illustrate the results, for the PGA endpoint, 50 percent of patients assigned to ferric carboxymaltose were either "much improved" or "moderately improved" at week 24 compared to only 28 percent of patients showing this kind of improvement in the placebo group. For NYHA class, the study showed that 47 percent of patients assigned to ferric carboxymaltose were in NYHA class I or II at week 24, compared to only 30 percent of patients on placebo therapy.