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 Japan and Korea

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.