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Tadalafil 5 mg once‐daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: Results from a randomized, double‐blind, placebo‐controlled trial carried out in J apan and K orea
Author(s) -
Takeda Masayuki,
Yokoyama Osamu,
Lee Sung Won,
Murakami Masahiro,
Morisaki Yoji,
Viktrup Lars
Publication year - 2014
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.12410
Subject(s) - tadalafil , medicine , placebo , lower urinary tract symptoms , tolerability , urology , hyperplasia , urinary system , randomized controlled trial , adverse effect , erectile dysfunction , prostate , pathology , alternative medicine , cancer
Objectives To gain further evidence on the efficacy, safety and tolerability of tadalafil 5 mg once‐daily in A sian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Methods Japanese and K orean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once‐daily tadalafil 5 mg ( n = 306) or placebo ( n = 304) for 12 weeks. Results A significantly greater improvement ( P < 0.001) in total I nternational P rostate S ymptom S core for the change from baseline (week 0) to study end‐point (week 12) was observed for tadalafil (−6.0) versus placebo (−4.5). Significantly greater improvements ( P < 0.01) in total I nternational P rostate S ymptom S core for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo. Significantly greater improvements ( P < 0.05) in I nternational P rostate S ymptom S core voiding and storage subscores, and I nternational P rostate S ymptom S core Q uality of L ife Index were observed for the change from baseline to end‐point for tadalafil versus placebo. Significantly greater improvements ( P < 0.001) in urinary symptoms were observed for tadalafil versus placebo for both P atient and C linician G lobal I mpressions of I mprovement. No new safety concerns were identified. Conclusions These findings confirm the efficacy and safety profile of tadalafil 5 mg once‐daily in A sian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.