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Registered at clinicaltrials.gov (NCT00966004). Objective• To evaluate the efficacy and safety of the β3-adrenoceptor agonist mirabegron, in a Japanese population with overactive bladder (OAB). Patients and Methods• This randomised, double-blind, placebo-controlled phase III study enrolled adult patients experiencing OAB symptoms for ≥24 weeks. Patients with ≥ 8 micturitions/24 h and ≥1 urgency episode/24 h or ≥1 urgency incontinence episode/24 h were randomised to once-daily placebo, mirabegron 50 mg or tolterodine 4 mg (as an active comparator, without testing for non-inferiority of efficacy and safety) for 12 weeks.• The primary endpoint was the change in the mean number of micturitions/24 h from baseline to final assessment. Secondary endpoints included micturition variables related to urgency and/or incontinence and quality-of-life domain scores on the King's Health Questionnaire.• Safety assessments included adverse events (AEs), post-void residual urine volume, laboratory variables, vital signs and 12-lead electrocardiogram. Results• A total of 1139 patients were randomised to receive placebo (n = 381), mirabegron 50 mg (n = 380) or tolterodine 4 mg (n = 378). Demographic and baseline characteristics were similar among the treatment groups.• At final assessment, mirabegron was significantly superior to placebo in terms of mean [SD] Conclusions• Mirabegron 50 mg once daily is an effective treatment for OAB symptoms, with a low occurrence of side effects in a Japanese population.

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Abbreviations & Acronyms 5ARI = 5-alpha-reductase inhibitors AE = adverse event ANCOVA = analysis of covariance BII = Benign Prostatic Hyperplasia Impact Index BMI = body mass index BPH = benign prostatic hyperplasia BPH-LUTS = lower urinary tract symptoms suggestive of benign prostatic hyperplasia CGI-I = Clinician Global Impression of Improvement ED = erectile dysfunction EjD = ejaculatory dysfunction IPSS = International Prostate Symptom Score ITT = intention-to-treat LS = least squares LUTS = lower urinary tract symptoms MMRM = mixed-effects model repeated measures PDE5 = phosphodiesterase type 5 PGI-I = Patient Global Impression of Improvement PPS = per protocol set PSA = prostate-specific antigen PVR = postvoid residual volume SAE = serious adverse event SD = standard deviation SE = standard errors TEAE = treatment-emergent adverse event Qmax = peak urinary flow rate QoL = quality of life 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.

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