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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
Author(s) -
Haque Nazneen,
Masumori Naoya,
Sakamoto Sadaaki,
Ye Zhangqun,
Yoon SangJin,
Kuo HannChorng,
Brotherton Betsy,
Wilson Timothy,
Muganurmath Chandra,
McLaughlin Megan,
Manyak Michael
Publication year - 2018
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1111/iju.13785
Subject(s) - medicine , tamsulosin , dutasteride , urology , international prostate symptom score , prostate , hyperplasia , urinary retention , tolerability , placebo , combination therapy , lower urinary tract symptoms , randomized controlled trial , adverse effect , alternative medicine , pathology , cancer
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.