Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study.
Author(s): Nickel JC, Roehrborn C, Montorsi F, Wilson TH, Rittmaster RS
Affiliation(s): Department of Urology, Queen's University, Kingston General Hospital, Ontario, Canada. firstname.lastname@example.org
Publication date & source: 2011-10, J Urol., 186(4):1313-8. Epub 2011 Aug 17.
Publication type: Multicenter Study; Randomized Controlled Trial
PURPOSE: Men at risk for prostate cancer may concurrently experience chronic prostatitis or pelvic pain. We evaluated the effect of dutasteride on prostatitis-like symptoms in the REDUCE study population. MATERIALS AND METHODS: REDUCE was a 4-year, randomized, double-blind, placebo controlled study of prostate cancer risk reduction with 0.5 mg dutasteride vs placebo in men 50 to 75 years old with prostate specific antigen 2.5 to 10 ng/ml and a negative prostate biopsy in the previous 6 months. In this analysis we investigated change from baseline in Chronic Prostatitis Symptom Index in men with prostatitis-like pain (Chronic Prostatitis Symptom Index pain subscore 5 or greater) and prostatitis-like syndrome (perineal or ejaculatory pain plus Chronic Prostatitis Symptom Index pain subscore 4 or greater), the proportion of subjects with at least a moderate Chronic Prostatitis Symptom Index response (6-unit or greater improvement) and reports of new onset clinical prostatitis. RESULTS: Of 5,379 men with a total baseline Chronic Prostatitis Symptom Index score 678 (12.6%) had prostatitis-like pain and 427 (7.9%) had prostatitis-like syndrome. Chronic Prostatitis Symptom Index total score decreased significantly at 48 months in the dutasteride group vs placebo in men with prostatitis-like pain (p <0.0001) and with prostatitis-like syndrome (t test p = 0.03). There were significantly more Chronic Prostatitis Symptom Index responders with dutasteride vs placebo in the prostatitis-like pain (49% vs 37%, respectively, p = 0.0033) and prostatitis-like syndrome (46% vs 35%, Fisher's exact test p = 0.0265) subgroups. Prostatitis was reported as an adverse event by significantly more men randomized to placebo (3.6%) than to dutasteride (2.5%, p = 0.003). CONCLUSIONS: Long-term dutasteride therapy resulted in improvement in prostatitis related symptoms in older men with an increased prostate specific antigen. Copyright (c) 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.