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Volume 338:557-563 February 26, 1998 Number 9 Next

	Full Text PDF Editorial by Wasson, J. H. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia, but the extent to which the benefit is sustained and whether finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, are not known.

Methods In this double-blind, randomized, placebo-controlled trial, we studied 3040 men with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of finasteride or placebo for four years. Symptom scores (on a scale of 1 to 34), urinary flow rates, and the occurrence of outcome events were assessed every four months in 3016 men. Prostate volume was measured in a subgroup of the men. Complete data on outcomes were available for 2760 men.

Results During the four-year study period, 152 of the 1503 men in the placebo group (10 percent) and 69 of the 1513 men in the finasteride group (5 percent) underwent surgery for benign prostatic hyperplasia (reduction in risk with finasteride, 55 percent; 95 percent confidence interval, 41 to 65 percent). Acute urinary retention developed in 99 men (7 percent) in the placebo group and 42 men (3 percent) in the finasteride group (reduction in risk with finasteride, 57 percent; 95 percent confidence interval, 40 to 69 percent). Among the men who completed the study, the mean decreases in the symptom score were 3.3 in the finasteride group and 1.3 in the placebo group (P<0.001). Treatment with finasteride also significantly improved urinary flow rates and reduced prostate volume (P<0.001).

Conclusions Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the probability of surgery and acute urinary retention.

Source Information

From the University of Texas Southwestern Medical Center, Dallas (J.D.M., C.G.R.); the University of Wisconsin Clinical Science Center, Madison (R.B.); the Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore (P.W., H.L.H.); Washington University School of Medicine, St. Louis (G.A.); the Mayo Clinic, Rochester, Minn. (M.L.); the University of Connecticut Health Center, Farmington (P.A.); Queen's University, Kingston, Ont., Canada (J.C.N.); and the Departments of Biostatistics (D.Z.W.) and Clinical Research, Endocrinology, and Metabolism (A.M.T., J.W.), Merck Research Laboratories, Rahway, N.J. Presented at the meeting of the Société Internationale d'Urologie, 24th World Congress, Montreal, September 8, 1997.

Address reprint requests to Dr. McConnell at the University of Texas Southwestern Medical Center, Department of Urology (J8-148), 5323 Harry Hines Blvd., Dallas, TX 75235-9110.

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