• Franklin C Lowe, John D McConnell, Perry B Hudson, Nicholas A Romas, Rex Boake, Michael Lieber, Mostafa Elhilali, Jack Geller, Juliane Imperto-McGinely, Gerald L Andriole, Reginald C Bruskewitz, Patrick C Walsh, Georg Bartsch, John N Nacey, Sukrut Shah, Frances Pappas, Amy Ko, Thomas Cook, Elizabeth Stoner, Joanne Waldstreicher, and Finasteride Study Group.
• Department of Urology, Saint Luke's-Roosevelt Hospital Center, New York, NY 10019, USA.
• Urology. 2003 Apr 1; 61 (4): 791-6.

ObjectivesTo summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important.MethodsThe North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate glands. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension. In total, 6-year finasteride data were available in 487 patients originally randomized to finasteride, and 5-year data were available on 238 patients originally randomized to placebo.ResultsAfter 6 years of treatment with finasteride 5 mg, the mean quasi-American Urological Association Symptom Score improved by 4.0 points, the median prostate volume decreased by 24%, and the mean maximal urinary flow rate increased by 2.9 mL/s (P <0.001 for all parameters). Long-term finasteride treatment was well tolerated, with a low incidence of drug-related sexual adverse events occurring during the first year and even fewer occurrences during the 5-year open extension.ConclusionsTreatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug-related adverse events over time.

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