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.

Abstract

OBJECTIVES:

To gain further evidence on the efficacy, safety and tolerability of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

METHODS:

Japanese and Korean 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 International Prostate Symptom Score 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 International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo. Significantly greater improvements (P < 0.05) in International Prostate Symptom Score voiding and storage subscores, and International Prostate Symptom Score Quality of Life 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 Patient and Clinician Global Impressions of Improvement. No new safety concerns were identified.

CONCLUSIONS:

These findings confirm the efficacy and safety profile of tadalafil 5 mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

• Authors: Masayuki Takeda, Osamu Yokoyama, Sung Won Lee, Masahiro Murakami, Yoji Morisaki, Lars Viktrup
• Journal: International journal of urology : official journal of the Japanese Urological Association (Int J Urol) Vol. 21 Issue 7 Pg. 670-5 (Jul 2014) ISSN: 1442-2042 [Electronic] Australia
• PMID: 24571205 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Japanese Urological Association.

Chemical References

• Carbolines
• Phosphodiesterase 5 Inhibitors
• Placebos
• Tadalafil

Topics

• Aged
• Asian People
• Carbolines (administration & dosage, adverse effects)
• Double-Blind Method
• Humans
• Japan
• Lower Urinary Tract Symptoms (drug therapy, etiology)
• Male
• Middle Aged
• Phosphodiesterase 5 Inhibitors (administration & dosage, adverse effects)
• Placebos
• Prostatic Hyperplasia (complications, drug therapy)
• Republic of Korea
• Tadalafil
• Treatment Outcome