Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia

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

Research output: Contribution to journalArticlepeer-review

91 Scopus citations


Objectives. To 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. Methods. The 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. Results. After 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. Conclusions. Treatment 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.

Original languageEnglish
Pages (from-to)791-796
Number of pages6
Issue number4
StatePublished - Apr 1 2003


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