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Superiority of dutasteride 0.5 mg and tamsulosin 0.2 mg for the treatment of moderate‐to‐severe benign prostatic hyperplasia in Asian men.

Authors :
Haque, Nazneen
Masumori, Naoya
Sakamoto, Sadaaki
Ye, Zhangqun
Yoon, Sang‐Jin
Kuo, Hann‐Chorng
Brotherton, Betsy
Wilson, Timothy
Muganurmath, Chandra
McLaughlin, Megan
Manyak, Michael
Source :
International Journal of Urology. Nov2018, Vol. 25 Issue 11, p944-951. 8p.
Publication Year :
2018

Abstract

Objectives: To assess the effectiveness and safety of dutasteride 0.5 mg + tamsulosin 0.2 mg combination compared with tamsulosin 0.2 mg in Asian men with moderate‐to‐severe benign prostatic hyperplasia. Methods: A 4‐week, single‐blind, placebo, run‐in was followed by a 2‐year double‐blind randomized controlled trial in men age ≥50 years with symptomatic benign prostatic hyperplasia, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate‐specific antigen ≥1.5 and ≤10 ng/mL, peak urinary flow >5 and ≤15 mL/s, and voided volume of ≥125 mL. Participants were randomized to oral daily dutasteride 0.5 mg + tamsulosin 0.2 mg combination or tamsulosin 0.2 mg. The primary efficacy end‐point was change in International Prostate Symptom Score at year 2. Results: Data from 607 participants showed a significant reduction in International Prostate Symptom Score (P < 0.05) at month 24, along with greater improvements (P ≤ 0.006) in peak urinary flow at every assessment and significant prostate volume reduction at months 12 and 24 (P < 0.001) in the combination group. Combination therapy was associated with a significant reduction in the risk of acute urinary retention or benign prostatic hyperplasia‐related surgery (P = 0.012), primarily due to a significant reduction in the risk of acute urinary retention (P = 0.005). The safety and tolerability profile of combination therapy was consistent with the known profiles for the individual monotherapies. Conclusions: Dutasteride 0.5 mg + tamsulosin 0.2 mg combination therapy showed better clinical outcomes than tamsulosin 0.2 mg monotherapy, making it an effective and safe treatment option for Asian men with moderate‐to‐severe benign prostatic hyperplasia. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
09198172
Volume :
25
Issue :
11
Database :
Academic Search Index
Journal :
International Journal of Urology
Publication Type :
Academic Journal
Accession number :
132783700
Full Text :
https://doi.org/10.1111/iju.13785