Urodynamic Efficacy and Safety of Mirabegron Add-on Treatment with Tamsulosin for Japanese Male Patients with Overactive Bladder

2015 ◽  
Vol 8 (3) ◽  
pp. 171-176 ◽  
Author(s):  
Naoki WADA ◽  
Hiromichi IUCHI ◽  
Masafumi KITA ◽  
Kazumi HASHIZUME ◽  
Seiji MATSUMOTO ◽  
...  
Keyword(s):  
Overactive Bladder ◽  
Efficacy And Safety ◽  
Japanese Male ◽  
Male Patients

scholarly journals Efficacy and safety of daily mirabegron 50 mg in male patients with overactive bladder: a critical analysis of five phase III studies

2017 ◽  
Vol 9 (6) ◽  
pp. 137-154 ◽  
Author(s):  
Andrea Tubaro ◽  
José E. Batista ◽  
Victor W. Nitti ◽  
Sender Herschorn ◽  
Christopher R. Chapple ◽  
...  
Keyword(s):  
Overactive Bladder ◽  
Placebo Treatment ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Prostatic Enlargement ◽  
Phase Iiib ◽  
Male Patients ◽  
Micturition Frequency ◽  
Phase Iii Studies ◽  
Tolterodine Er

Background: Oral pharmacotherapies to treat overactive bladder (OAB) are used less in men despite a similar prevalence of storage symptoms as women. The efficacy and safety of once-daily mirabegron 50 mg was evaluated in male OAB patients from five phase III studies that included placebo or antimuscarinic (tolterodine ER 4 mg or solifenacin 5 mg) as a comparator. Methods: Three pooled 12-week placebo-controlled studies (mirabegron 50 mg versus placebo) and one 12-week non-inferiority phase IIIb study (BEYOND; mirabegron 50 mg versus solifenacin 5 mg) were used for efficacy (daily micturition frequency, urgency and incontinence episodes) and safety analyses. An additional 52-week active-controlled phase III safety study (mirabegron 50 mg versus tolterodine ER 4 mg) was included in the safety analysis. Male patients aged ⩾18 years with OAB for ⩾3 months were included in the analyses. Patients may also have a history of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)/benign prostatic enlargement (BPE) or concomitant use of α1-blockers. Results: In the pooled studies, mirabegron 50 mg demonstrated superiority versus placebo (treatment difference: −0.37 [95% confidence interval (CI): −0.74, −0.01]) for reducing micturition frequency; improvements in urgency and incontinence were not significantly different between mirabegron 50 mg and placebo. In BEYOND, mirabegron 50 mg was comparable with solifenacin 5 mg for reducing micturition frequency, urgency, and incontinence episodes. Mirabegron was well tolerated at 12 and 52 weeks and overall treatment-emergent adverse events (AEs) were similar to those with placebo. Conclusions: In a male OAB population with or without LUTS associated with BPH/BPE, mirabegron 50 mg provided similar improvements in urgency, frequency, and incontinence as solifenacin 5 mg, and is a well-tolerated alternative to antimuscarinics. In the three pooled 12-week studies, significant differences were not seen for urgency and incontinence versus placebo, although mirabegron 50 mg did demonstrate significant improvements versus placebo for frequency.

Correlation Between Overactive Bladder Symptoms and Quality of Life in Japanese Male Patients: Focus on Nocturia

Urology ◽  
2013 ◽  
Vol 82 (1) ◽  
pp. 189-193 ◽  
Author(s):  
Tetsuya Takao ◽  
Akira Tsujimura ◽  
Hiroshi Kiuchi ◽  
Kentaro Takezawa ◽  
Hidenobu Okuda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overactive Bladder ◽  
Overactive Bladder Symptoms ◽  
Japanese Male ◽  
Bladder Symptoms ◽  
Male Patients
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