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Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A randomized placebo‐ and tamsulosin‐controlled 12‐week study in A sian men
Author(s) -
Yokoyama Osamu,
Yoshida Masaki,
Kim Sae Chul,
Wang ChiiJye,
Imaoka Takeshi,
Morisaki Yoji,
Viktrup Lars
Publication year - 2013
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/j.1442-2042.2012.03130.x
Subject(s) - tadalafil , international prostate symptom score , medicine , lower urinary tract symptoms , urology , placebo , tamsulosin , prostate , hyperplasia , urinary system , erectile dysfunction , pathology , alternative medicine , cancer
Objectives To examine the efficacy and safety of tadalafil in A sian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Methods Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once‐daily placebo ( n = 154), tadalafil 2.5 mg ( n = 151), tadalafil 5.0 mg ( n = 155) or tamsulosin 0.2 mg (active control, n = 152) for 12 weeks. Results Total I nternational P rostate S ymptom S core least‐squares mean changes from baseline to end‐point significantly improved with tadalafil 2.5 mg (−4.8, P = 0.003) and 5 mg (−4.7, P = 0.004) versus placebo (−3.0). Significant improvement in the I nternational P rostate S ymptom S core versus placebo was observed earlier (week 2) for tadalafil 5.0 mg than for tadalafil 2.5 mg (week 8). Significant improvements ( P < 0.05) in both tadalafil groups versus placebo were observed for the I nternational P rostate S ymptom S core voiding subscore, I nternational P rostate S ymptom S core Q uality of L ife, and for P atient and C linician G lobal I mpressions of I mprovement. Significant improvements versus placebo were observed in the I nternational P rostate S ymptom Score storage subscore for tadalafil 5.0 mg (−1.7, P = 0.021), but not tadalafil 2.5 mg (−1.5, P = 0.072). No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo. Tamsulosin treatment resulted in significant improvements versus placebo across all efficacy parameters, except for peak urinary flow rates. Safety results were consistent with the known tadalafil and tamsulosin safety profiles. Conclusions Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.