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Sildenafil Safe for Heart-failure Patients Taking Ramipril: Presented at ASH(HYP)

By Ed Susman

NEW YORK, NY -- May 20, 2003 -- People with heart failure who are taking the angiotensin-converting enzyme (ACE) inhibitor ramipril, can safely use the sexual dysfunction drug sildenafil.

Research proved that the combination of ramipril and sildenafil was not only safe, but appeared to contain additional benefits for heart-failure patients. The study was presented here on May 15^th at the 18^th Annual Scientific Meeting of the American Society of Hypertension.

Katarzyna Hryniewicz, MD, a research associate in the section of cardiovascular medicine, Yale University School of Medicine, New Haven, Conn, said the study of 64 heart-failure patients was of importance, because about half of all male heart-failure patients experience sexual dysfunction.

The prospective, randomized, double-blind trial enrolled 57 men and 7 women with New York Heart Association Class II-III congestive heart failure. The average age of the patients was 56 years, left-ventricular function averaged 23%.

Patients received 1 of 4 treatments: a single oral dose of ramipril 10 mg; a single oral dose of sildenafil 50 mg; a combination of the two; or placebo. The researchers evaluated effects on flow-mediated dilation of the brachial artery by high-resolution ultrasonography of the blood vessel of the arm over a 4-hour period. Background ACE inhibitors were stopped 72 hours before the study.

Results show that placebo did not change flow-mediated dilation over the 4 hour study period. Ramipril, however, tended to increase flow-mediated dilation when compared with placebo at 4 hours, although the difference failed to achieve statistical significance P=0.11).

Sildenafil significantly increased flow-mediated dilation when compared with placebo at 1 and 2 hours (P<0.05). The combination of ramipril and sildenafil had additive effects that significantly increased flow-mediated dilation at 1, 2, and 4 hours when compared with placebo (P<0.05).

Sildenafil did not increase the acute blood-pressure lowering effects of ramipril.

This study observed only the drug-drug reactions of ramipril and sildenafil, and did not record whether the patients had erectile dysfunction (ED), nor whether the use of sildenafil in the study setting had an effect on ED. Similarly, it did not record whether the use of sildenafil in women had an impact on sexual functioning. (Previous case reports have suggested some women receive sexual functioning benefits from the drug.)


[Study title: Comparative Effects of Ramipril, Sildenafil, or Both on Endothelial Function in Patients With Chronic Heart Failure. Abstract P-94]

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