News Release

Drug for erectile dysfunction appears safe for some men with congestive heart failure

Peer-Reviewed Publication

JAMA Network

CHICAGO – Carefully selected men with congestive heart failure appear to be able to safely take sildenafil, a drug used to treat erectile dysfunction (ED), if they are not taking nitrates to treat their heart condition, and have no evidence of myocardial ischemia, according to an article in the March 8 issue of The Archives of Internal Medicine, one of the JAMA/Archives journals.

Erectile dysfunction affects an estimated 52 percent of men aged 40 to 70, is common in patients with congestive heart failure (CHF), and is associated with symptoms of depression, according to the article. Reports of deaths associated with sildenafil caused some physicians not to prescribe the drug to patients with heart disease. Sildenafil can decrease blood pressure in patients who take nitrates, and should not be taken by this group, the article states.

Linda J. Webster, M.Sc.N., of the University of Alberta, Edmonton, Canada, and colleagues studied the effectiveness and safety of sildenafil among 35 carefully selected men with CHF who did not use nitrates. The men were randomly assigned to one of two groups: one group took sildenafil for six weeks, then switched to a placebo for another six weeks. The other group started with placebo for six weeks, then switched to sildenafil for the remainder of the 12-week study. Follow-up visits took place at 2, 4, 6, 8, 10, and 12 weeks.

The researchers found even though sildenafil caused a slight reduction in blood pressure, no patient in the study experienced a dangerous drop in blood pressure while taking sildenafil. In addition, sildenafil improved erectile dysfunction and also appeared to reduce depression.

"The major finding of this study is that sildenafil is safe and effective in treating ED in men with moderate… heart failure who undergo appropriate screening," write the authors.

"Although the use of sildenafil in patients with CHF at present is considered a relative contraindication, our findings suggest that this drug can be prescribed in patients with moderately severe CHF, provided that they are not taking nitrates and they have no evidence of myocardial ischemia [lack of oxygen to the heart muscle]," write the researchers.

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(Arch Intern Med. 2004;164:514-520. Available post-embargo at archinternmed.com)

Editor's Note: This study was supported by a grant from the University of Alberta Hospital Foundation, Edmonton. Drs. Michelakis and Archer are supported by Alberta Heritage Foundation for Medical Research, Edmonton; Canadian Institutes of Health Research, Ottawa, Ontario; the Heart and Stroke Foundation of Canada, Ottawa, and the Canadian Foundation for Innovation, Ottawa.

For more information, contact JAMA/Archives Media Relations at 312-464-JAMA (5262) or e-mail mediarelations@jama-archives.org .

To contact corresponding author Stephen L. Archer, M.D., call Phoebe Dey at 780-492-0437.


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