LONG-TERM (7 to 8-YEAR) EXPERIENCE WITH FINASTERIDE IN MEN WITH BENIGN PROSTATIC HYPERPLASIA D. VAUGHAN, J. IMPERATO-MCGINLEY, J. MCCONNELL, A. M. MATSUMOTO, B. BRACKEN, J. ROY, M. SULLIVAN, F. PAPPAS, T. COOK, C. DAURIO, A. MEEHAN, E. STONER, AND J. WALDSTREICHER ABSTRACT Objectives. To evaluate the effects of finasteride, a specific type II 5-alpha-reductase inhibitor, on symp- toms of benign prostatic hyperplasia, prostate volume, and urinary flow during a 7 to 8-year period. Methods. A total of 190 men with symptomatic benign prostatic hyperplasia and enlarged prostates entered one of two Phase II double-blind 3 to 6-month studies. Of these, 156 patients continued taking open-label finasteride, and more than 70 patients completed 7 to 8 years of treatment. The symptoms were scored using a patient self-administered modified Boyarsky symptom questionnaire. Prostate volume was measured by magnetic resonance imaging or ultrasonography, and the maximal urinary flow rate was assessed noninvasively. Results. Treatment with finasteride for 7 to 8 years led to sustained improvement in symptoms, reduction in prostate volume (28% from baseline), and increased urinary flow (median 2.5 mL/s from baseline). Decreases in dihydrotestosterone (86%) and prostate-specific antigen (54%) levels were also maintained. Long-term finasteride treatment was safe and generally well tolerated. Conclusions. Long-term treatment with finasteride was well tolerated and resulted in durable symptom relief and improvement in prostate volume and urinary flow. UROLOGY 60: 1040–1044, 2002. © 2002, Elsevier Science Inc. B enign prostatic hyperplasia (BPH) is caused by androgen-dependent proliferation of prostatic tissue. 1 The androgen principally involved in this process in the prostate is 5-alpha-dihydrotestoster- one (DHT), formed through reduction of testoster- one by the enzyme type II 5-alpha-reductase. Fin- asteride, a selective and specific inhibitor of type II 5-alpha-reductase, suppresses formation of intra- prostatic DHT by up to 90%, resulting in reduction of prostatic volume. 2 Double-blind, placebo-con- trolled studies in men with BPH have shown finas- teride to be well tolerated and to reduce prostate volume, alleviate symptoms, and improve urinary flow rates effectively. 2–8 Moreover, finasteride de- creases the risk of developing acute urinary reten- tion or needing BPH-related surgery by more than 50%. 8 –10 Because BPH is a chronic and progressive dis- ease, it is important to assess the long-term effec- tiveness and safety of drugs used in the treatment of this condition. We previously reported on the results of the base studies, 2 1-year open extension studies, 11 and 5-year open extension studies 12 from two Phase II double-blind, placebo-controlled clinical trials in men with BPH that demonstrated finasteride’s sustained benefit and excellent safety profile in these patients. This report presents addi- This study was funded by Merck & Co., Inc. D. Vaughan, J. Imperato-McGinley, J. McConnell, A. M. Mat- sumoto, B. Bracken, J. Roy, and M. Sullivan were study investi- gators funded by the sponsors. J. Imperato-McGinley, J. McCon- nell, A. M. Matsumoto, and J. Roy have been paid consultants to the sponsor. A. M. Matsumoto has also been a paid consultant to a competitor of the sponsor, GlaxoSmithKline. J. Roy holds stock in the sponsor. F. Pappas, T. Cook, C. Daurio, A. Meehan, E. Stoner, and J. Waldstreicher are employees of, and hold stock in, the sponsor. From the Cornell University Medical Center, New York, New York; University of Texas, Dallas, Texas; Veterans Affairs Puget Sound Healthcare System, University of Washington School of Medicine, Seattle, Washington; University of Cincinnati, Cincin- nati, Ohio; Edmond, Oklahoma; Mercy Research Clinic, San Di- ego, California; and Merck Research Laboratories, Rahway, New Jersey Reprint requests: Joanne Waldstreicher, M.D., Merck Research Laboratories, RY34-A212, 126 East Lincoln Avenue, Rahway, NJ 07065-0900 Submitted: March 28, 2002, accepted (with revisions): July 26, 2002 ADULT UROLOGY CME ARTICLE © 2002, ELSEVIER SCIENCE INC. 0090-4295/02/$22.00 1040 ALL RIGHTS RESERVED PII S0090-4295(02)01971-4