Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years
Objectives. The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH). Methods. A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive...
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Published in | Urology (Ridgewood, N.J.) Vol. 53; no. 4; pp. 690 - 695 |
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Main Authors | , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
New York, NY
Elsevier Inc
01.04.1999
Elsevier Science |
Subjects | |
Online Access | Get full text |
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Summary: | Objectives. The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH).
Methods. A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 mg. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12-month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years.
Results. Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of −24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (
P <0.001), the quasi-American Urological Association symptom score was decreased by 4.3 points, and maximal urinary flow was increased by 2.3 mL/s (
P <0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time.
Conclusions. Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years. |
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ISSN: | 0090-4295 1527-9995 |
DOI: | 10.1016/S0090-4295(98)00666-9 |