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Sildenafil May Yield Modest Benefits in Systolic Heart Failure: Presented at HFSA

By Bonnie Darves

SEATTLE, WA -- September 18, 2006 -- A new study of sildenafil, a drug commonly prescribed for erectile dysfunction and pulmonary arterial hypertension, has found that the medication may also improve exercise capacity and quality of life while reducing heart failure (HF)-associated hospitalizations in patients with systolic HF.

In a randomized, placebo-controlled study, patients who received sildenafil were able to improve their 6-minute walk distance by 13% -- a modest but notable gain for patients with Class III or IV systolic HF, according to the study's chief author, Gregory D. Lewis, MD, researcher, Massachusetts General Hospital, Boston, Massachusetts.

Researchers plan to look further at the data to determine whether sildenafil "has peripheral effects, such as improving endothelial function" in HF patients, and to assess remodeling effects, Dr. Lewis said.

The double-blind, placebo-controlled study, presented here on September 11^th at the Heart Failure Society of America 10^th annual scientific meeting (HSFA), randomized 40 patients with New York Heart Association Class III or IV systolic HF and secondary pulmonary hypertension to receive either placebo or oral sildenafil, in doses of up to 50 mg 3 times daily, as tolerated, for 12 weeks.

Study subjects were assessed at baseline and 12 weeks after the initial sildenafil dose, for right heart hemodynamics, gas exchange, neurohormonal levels and ventriculography.

At the end of the study, the 14 patients on sildenafil not only demonstrated improved exercise capacity but also had fewer hospitalizations for HF -- 1 versus 7 in the placebo group.

At completion of the study, all patients were eligible to receive open-label sildenafil.

Sildenafil's safety profile in the HF patients appeared favorable, in that adverse events did not differ significantly between the 2 groups, according to the researchers.


[Presentation title: Sildenafil Therapy for Systolic Heart Failure with Secondary Pulmonary Hypertension: A Randomized Double-Blind, Placebo-Controlled Study. Abstract 223]

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