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Largest Study to Date Finds Viagra Effective for Severe Erectile Dysfunction

An analysis of data from 10 studies shows that treatment with oral sildenafil (Viagra) is effective in men with severe erectile dysfunction (ED), according to Dr. William Steers, chairman of the urology department at the University of Virginia Health System. Steers reported his findings today at the 93rd Annual Meeting of the American Urological Association in San Diego.

Erectile dysfunction -- the persistent inability to achieve and/or maintain an erection sufficient for satisfactory sexual performance -- is estimated to afflict over 30 million men in the United States.

In the largest study to date, data for 3,361 patients with ED from 10 double-blind, placebo-controlled, fixed-dose or flexible-dose studies of sildenafil (50 mg – 100 mg) were evaluated in this analysis. In these clinical studies, sildenafil or placebo was taken as needed one hour prior to sexual activity for eight weeks. The ability to achieve an erection and to maintain an erection was assessed at the beginning and end of the study period using the self-administered International Index of Erectile Function (IIEF).

Patients enrolled in the trials were: 18 years of age or older; in a stable relationship with a female partner; and clinically diagnosed with ED for more than six months. Of the 3,361 patients with ED who were analyzed, a total of 2,085 were categorized as having severe ED with inability to obtain an erection for intercourse always or almost always.

In the patients with severe ED, sildenafil significantly improved the ability to achieve and maintain erections, Steers said. Analysis of the data showed that sildenafil is an effective oral therapy, with response rates ranging from 46 percent to 73 percent depending on how outcome performance is defined.

May 27, 1998