Efficacy and safety of tadalafil 5mg once-daily in Asian men with both lower urinary tract symptoms associated with benign prostatic hyperplasia and erectile dysfunction: A phase3, randomized, double-blind, parallel, placebo- and tamsulosin-controlled study.

Abstract

To evaluate the efficacy and safety of tadalafil in Asian men with both lower urinary tract symptoms associated with benign prostatic hyperplasia and erectile dysfunction. The present phase3, randomized, double-blind, parallel, placebo- and tamsulosin-controlled study was carried out at 40 study centers in the Asia-Pacific region (mainland China, Taiwan and Korea; NCT01937871). Participants were randomized to receive a placebo (n=361), tadalafil 5mg (n=362) or tamsulosin 0.2mg (n=185) in a 2:2:1 ratio for 12weeks. A total of 909 Asian men were randomized into three groups. After 12weeks of treatment, a statistically significant improvement in least squares mean change from baseline in total International Prostate Symptom Score was observed in the tadalafil versus the placebo group (-5.49 vs -4.08, respectively; P<0.001). A statistically significant improvement in the change from baseline for the International Index of Erectile Function-Erectile Function domain score, was observed in tadalafil compared with the placebo at 12weeks (5.24 vs 1.88, respectively; P<0.001). A significant improvement was observed in the change from baseline in the percentage of "Yes" responses to Sexual Encounter Profile questions2 and 3 in the tadalafil versus placebo group at 12weeks (23.87% vs 10.90%; P<0.001 and 36.62% vs 15.96%; P<0.001, respectively). Safety results were consistent with the known tadalafil safety profile. Tadalafil is efficacious and well tolerated in the treatment of Asian men with both lower urinary tract symptoms associated with benign prostatic hyperplasia and erectile dysfunction.