1. Efficacy and safety of tadalafil 5 mg once-daily in Asian men with both lower urinary tract symptoms associated with benign prostatic hyperplasia and erectile dysfunction: A phase 3, randomized, double-blind, parallel, placebo- and tamsulosin-controlled study.
- Author
-
Zhang Z, Li H, Zhang X, Dai Y, Park HJ, Jiann BP, Li P, Lou Y, Ye Z, and Viktrup L
- Subjects
- Aged, China, Double-Blind Method, Erectile Dysfunction diagnosis, Erectile Dysfunction etiology, Humans, Lower Urinary Tract Symptoms etiology, Male, Middle Aged, Placebos administration & dosage, Prostatic Hyperplasia complications, Republic of Korea, Severity of Illness Index, Taiwan, Tamsulosin administration & dosage, Treatment Outcome, Erectile Dysfunction drug therapy, Lower Urinary Tract Symptoms drug therapy, Phosphodiesterase 5 Inhibitors administration & dosage, Prostatic Hyperplasia drug therapy, Tadalafil administration & dosage
- Abstract
Objective: 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., Methods: The present phase 3, 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 5 mg (n = 362) or tamsulosin 0.2 mg (n = 185) in a 2:2:1 ratio for 12 weeks., Results: A total of 909 Asian men were randomized into three groups. After 12 weeks 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 12 weeks (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 questions 2 and 3 in the tadalafil versus placebo group at 12 weeks (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., Conclusions: 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., (© 2018 The Japanese Urological Association.)
- Published
- 2019
- Full Text
- View/download PDF