Abstract | OBJECTIVE: METHODS: REDUCE was a multicenter, randomized, double-blind, placebo-controlled study of prostate cancer risk reduction with daily dutasteride 0.5 mg or placebo. Eligible men were aged 50-75 years, with a prostate-specific antigen level of 2.5-10 ng/mL and a prostate volume of ≤80 cm3. The prespecified and post hoc analyses were performed on the incidence of acute urinary retention, BPH-related surgery, and urinary tract infections, as well as on changes in prostate volume, International Prostate Symptom Score, BPH Impact Index, and maximal urinary flow rate (Qmax). RESULTS: A total of 8122 men were included in the efficacy population. During the 4-year study, the International Prostate Symptom Score increased in placebo-treated patients, while dutasteride-treated patients had a stabilized or decreased International Prostate Symptom Score and improved BPH Impact Index and quality of life due to urinary symptom scores across all prostate volume quintiles (including prostate glands smaller than those studied in previous dutasteride trials). 48 months, the incidence of acute urinary retention or BPH-related surgery was significantly less in the dutasteride group (2.5%) than in the placebo group (9%) overall (P<.001) and in each baseline prostate volume quintile (P<.01). CONCLUSION: During the 4-year study, dutasteride was associated with a decreased risk of BPH progression in men with mild-to-moderate symptoms and normal or enlarged prostates.
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Authors | Claus G Roehrborn, J Curtis Nickel, Gerald L Andriole, R Paul Gagnier, Libby Black, Timothy H Wilson, Roger S Rittmaster |
Journal | Urology
(Urology)
Vol. 78
Issue 3
Pg. 641-6
(Sep 2011)
ISSN: 1527-9995 [Electronic] United States |
PMID | 21764428
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 Elsevier Inc. All rights reserved. |
Chemical References |
- 5-alpha Reductase Inhibitors
- Azasteroids
- Dutasteride
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Topics |
- 5-alpha Reductase Inhibitors
(administration & dosage)
- Aged
- Azasteroids
(therapeutic use)
- Double-Blind Method
- Dutasteride
- Humans
- Male
- Middle Aged
- Organ Size
- Prostate
(pathology)
- Prostatic Hyperplasia
(complications, drug therapy, pathology)
- Prostatic Neoplasms
(etiology, prevention & control)
- Risk Reduction Behavior
- Urinary Retention
(etiology)
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