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
- Issue Date
- Nov-2018
- Publisher
- WILEY
- Keywords
- benign prostatic hyperplasia; combination therapy; dutasteride; International Prostate Symptom Score; tamsulosin
- Citation
- INTERNATIONAL JOURNAL OF UROLOGY, v.25, no.11, pp.944 - 951
- Journal Title
- INTERNATIONAL JOURNAL OF UROLOGY
- Volume
- 25
- Number
- 11
- Start Page
- 944
- End Page
- 951
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/3105
- DOI
- 10.1111/iju.13785
- ISSN
- 0919-8172
- 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.
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