Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia

• Published in: Urology (Ridgewood, N.J.) Vol. 60; no. 6; pp. 1040 - 1044
• Main Authors: Vaughan, D, Imperato-McGinley, J, McConnell, J, Matsumoto, A.M, Bracken, B, Roy, J, Sullivan, M, Pappas, F, Cook, T, Daurio, C, Meehan, A, Stoner, E, Waldstreicher, J
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.12.2002; Elsevier Science
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Double-Blind Method; Enzyme Inhibitors - adverse effects; Enzyme Inhibitors - therapeutic use; Finasteride - adverse effects; Finasteride - therapeutic use; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Prostatic Hyperplasia - drug therapy; Prostatic Hyperplasia - physiopathology; Tumors of the urinary system; Urinary tract. Prostate gland; Urination; Human; Urinary system disease; Finasteride; Prostate disease; Male; Adenoma; Azasteroid; Symptomatology; Chemotherapy; Treatment; Follow up study; Adult; Benign neoplasm; Male genital diseases; Prostate
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/S0090-4295(02)01971-4

To evaluate the effects of finasteride, a specific type II 5-alpha-reductase inhibitor, on symptoms of benign prostatic hyperplasia, prostate volume, and urinary flow during a 7 to 8-year period. 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. 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. Long-term treatment with finasteride was well tolerated and resulted in durable symptom relief and improvement in prostate volume and urinary flow.