Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years

• Published in: Urology (Ridgewood, N.J.) Vol. 53; no. 4; pp. 690 - 695
• Main Authors: Hudson, Perry B., Boake, Rex, Trachtenberg, John, Romas, Nicholas A., Rosenblatt, Sidney, Narayan, Perinchery, Geller, Jack, Lieber, Michael M., Elhilali, Mostafa, Norman, Richard, Patterson, Lynn, Perreault, Jean-Paul, Malek, Gholam H., Bruskewitz, Reginald C., Roy, Johnny B., Ko, Amy, Jacobsen, Carol A., Stoner, Elizabeth
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.04.1999; Elsevier Science
• Subjects: Biological and medical sciences; Medical sciences; Nephrology. Urinary tract diseases; Tumors of the urinary system; Urinary tract. Prostate gland; Phase III trial; Human; Urinary system disease; Finasteride; Prostate disease; Evaluation scale; Treatment efficiency; Male; Adenoma; Azasteroid; Long term; Cystometry; Volume; Prostatism; Benign neoplasm; Male genital diseases; Prostate
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/S0090-4295(98)00666-9

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.