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. 2017 May 10;9(6):137-154.
doi: 10.1177/1756287217702797. eCollection 2017 Dec.

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

Andrea Tubaro  1 , José E Batista  2 , Victor W Nitti  3 , Sender Herschorn  4 , Christopher R Chapple  5 , Mary Beth Blauwet  6 , Emad Siddiqui  7 , Moses Huang  7 , Matthias Oelke  8
Affiliations

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

Andrea Tubaro et al. Ther Adv Urol. .

Abstract

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.

Keywords: LUTS; benign prostatic enlargement; benign prostatic hyperplasia; male patients; mirabegron; overactive bladder.

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Conflict of interest statement

Conflict of interest statement: A.T. has received consultancy fees from Allergan (Dublin, Ireland), Astellas (Tokyo, Japan), AMS/Boston Scientific (Marlborough, USA), Bayer (Leverkusen, Germany), GSK (Middlesex, UK), and Shionogy (Florham Park, USA); investigator for GSK, Shionogy, Bayer, and Pierre Fabre (Paris, France). J.E.B. received investigator and speaker fees for Astellas and course coordinator fees from Gebro Pharma (Fieberbrunn, Austria). V.W.N. is an investigator for Allergan (Dublin, Ireland), Astellas, and Cook Myosite (Pittsburgh, USA). S.H. has received consultancy fees from Astellas, Allergan, Pfizer (New York City, USA), Merus (Utrecht, The Netherlands), and Ferring (Saint-Prex, Switzerland); grants from Astellas and Allergan. C.R.C. has received consultancy, research, and speaker fees from Allergan, Astellas, Medtronic, and Recordati (Milan, Italy); consultancy and speaker fees from Lilly (Indiana, USA); research and speaker fees from ONO (Osaka, Japan) and Pfizer; and speaker fees from Ranbaxy (Haryana, India). M.B.B., E.S., and M.H. are employees of Astellas. M.O. has received speaker and consultancy fees from Apogepha (Dresden, Germany), Astellas, Bayer, Duchesnay (Québec, Canada), Ferring, GlaxoSmithKline, Lilly, Pfizer, and Recordati; and grants from Astellas.

Figures

Figure 1.
Figure 1.
Summary of the study designs for the phase III randomized controlled trials included in the analysis of male patients.
Figure 2.
Figure 2.
Adjusted mean change from baseline to EoT in male patients for the key OAB efficacy parameters in the pooled phase III studies (SCORPIO, ARIES, CAPRICORN), and phase IIIb study (BEYOND): (a) mean number of micturitions/24 h (FAS), (b) mean number of urgency episodes (grade 3 or 4 of PPIUS)/24 h (FAS), and (c) mean number of incontinence episode/24 h (FAS-I). CI, confidence interval; EoT, end of treatment; FAS, full analysis set; FAS-I, full analysis set-incontinence; OAB, overactive bladder; PPIUS, Patient Perception of Intensity of Urgency Scale; SE, standard error.
Figure 3.
Figure 3.
Change from baseline to EoT in PVR volume (pooled 12-week studies only) (SAF): (a) males with a history of LUTS associated with BPH/BPE, and (b) males without a history of LUTS associated with BPH/BPE. BPE, benign prostatic enlargement; BPH, benign prostatic hyperplasia; CI, confidence interval; EoT, end of treatment; LUTS, lower urinary tract symptoms; PVR, post-void residual; SAF, safety analysis set; SD, standard deviation.
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