Objectives: To examine the efficacy and safety of tadalafil in Asian 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 International Prostate Symptom Score 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 International Prostate Symptom Score 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 International Prostate Symptom Score voiding subscore, International Prostate Symptom Score Quality of Life, and for Patient and Clinician Global Impressions of Improvement. Significant improvements versus placebo were observed in the International Prostate Symptom 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.
© 2012 The Japanese Urological Association.