Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia.
OBJECTIVE
To assess the efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia (BPH).


METHODS
This was a randomized, double-blind, placebo-controlled, parallel-group study. A total of 378 subjects with clinical BPH having an International Prostate Symptom Score (IPSS) of 8 points or greater, a prostate volume of 30 mL or greater, and a maximal urinary flow rate (Qmax) of 15 mL/s or less were randomized to receive placebo or dutasteride once daily for 52 weeks. Subjects were stratified according to tamsulosin use at baseline. The numbers of subjects with and without tamsulosin use were 242 and 136, respectively. IPSS, Qmax, prostate volume and drug safety were evaluated.


RESULTS
Continued improvement in IPSS was noted in the dutasteride group, and dutasteride significantly decreased IPSS compared with placebo. At week 52, dutasteride significantly improved Qmax and prostate volume compared with placebo. Drug-related sexual function events in the dutasteride group were infrequent and generally were not treatment limiting.


CONCLUSIONS
Dutasteride improves urinary symptoms and flow rate and reduces prostate volume. In Japanese men with BPH, it is effective and generally well tolerated during the one-year treatment period.
Tsukamoto
Taiji
T
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan. taijit@sapmed.ac.jp
Endo
Yukihiro
Y
Narita
Michiro
M
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D001378:Azasteroids / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000033:anatomy & histology / Q000187:drug effects*; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000503:physiopathology; D053448:Prostatism / Q000188:drug therapy; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D036761:Ultrasound, High-Intensity Focused, Transrectal; D014563:Urodynamics
D000317:Adrenergic alpha-Antagonists; D001378:Azasteroids; D004791:Enzyme Inhibitors; D013449:Sulfonamides; D017430:Prostate-Specific Antigen; D000077409:Tamsulosin; D000068538:Dutasteride