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| |  Study Shows Proscar Reduces Need for Prostate Surgery NEW ORLEANS, LA -- April 13, 1997 -- For the first time, an outcomes analysis of three major clinical studies has shown that Proscar(R) (finasteride 5 mg) significantly reduced prostate surgery and acute urinary retention in men over 50 with symptomatic prostate enlargement compared to men treated with placebo. According to the analysis, prostate surgery -- also known as transurethral resection of the prostate or TURP -- was reduced by 33 percent and acute urinary retention by 57 percent over a two-year treatment period. Jens Andersen, M.D., of the University of Copenhagen in Denmark, presented these findings today at the 92nd Annual Meeting of the American Urological Association (AUA). "This is the first study to show that Proscar reduced surgery and urinary retention -- critical markers of disease progression -- in men with prostate enlargement," said Elizabeth Stoner, M.D., Vice President, Merck Research Laboratories. A four-year trial designed to confirm the findings of this outcomes study will be completed soon, according to Dr. Stoner. According to the Agency for Health Care Policy and Research in its 1994 guidelines about prostate enlargement and its treatment, prostate enlargement leads to over 300,000 surgeries annually, most of them TURPs, in the U.S. at a cost of about $2 billion. Acute urinary retention is a condition that occurs when a man with prostate enlargement is unable to urinate. It is considered a medical emergency that requires immediate attention. The statistical analysis that led to these findings is based on three double-blind, placebo-controlled, randomized, multicenter studies in 46 countries of 4,477 men with mild to moderate symptoms of prostate enlargement. The three trials evaluated for this analysis were the Scandinavian Reduction of the Prostate Study (SCARP), the Proscar Safety Plus Efficacy Canadian Two-year Study (PROSPECT) and the Proscar Worldwide Efficacy and Safety Study (PROWESS). Proscar was licensed for marketing in 1992 by the U.S. Food and Drug Administration. Proscar lowers the level of dihydrotestosterone (DHT), the key hormone that contributes to prostate enlargement in aging men. This leads to shrinkage of the enlarged gland in most men, improving urinary flow and symptoms. In clinical trials, Proscar was generally well tolerated by most patients. The most common drug-related adverse effects were impotence (3.7 percent), decreased libido (3.3 percent) and decreased volume of ejaculate (2.8 percent). Merck & Co., Inc. is a research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative pharmaceutical products to improve human health.
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