The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial

To compare the efficacy and safety of mirabegron 50 mg and solifenacin 5 mg in overactive bladder (OAB) patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy.

This randomized, double-blind, phase IIIb, noninferiority study, enrolled male and female patients aged ⩾18 years old, with symptoms of OAB for ⩾3 months, who were dissatisfied with their previous antimuscarinic drug due to lack of efficacy.

A total of 1887 patients were randomized to receive mirabegron 50 mg (n = 943) or solifenacin 5 mg (n = 944) daily for 12 weeks. The primary efficacy endpoint was change from baseline to end of treatment in mean number of micturitions/24 h. Noninferiority was confirmed if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference between solifenacin and mirabegron was > -0. 20. Secondary efficacy endpoints, which included change from baseline in mean number of incontinence episodes/24 h, urgency incontinence episodes/24 h, urgency episodes (grade 3 or 4)/24 h and nocturia episodes/24 h, were analyzed using analysis of covariance.

For the primary endpoint, adjusted mean treatment difference (95% CI) in mean number of micturitions/24 h was -0. 18 (-0. 42, 0. 06) and therefore noninferiority of mirabegron to solifenacin was not demonstrated. Both treatments demonstrated clinically meaningful reductions in efficacy variables and were well tolerated, with a lower incidence of dry mouth with mirabegron.

Noninferiority of mirabegron compared with solifenacin for reduction in micturition frequency could not be demonstrated in this population of OAB patients who were dissatisfied with previous antimuscarinic therapy due to lack of efficacy. Both mirabegron and solifenacin improved key OAB symptoms with no statistically significant differences observed between the two treatments. Both drugs were well tolerated.

Therapeutic advances in urology. 2015 Aug [Epub]

Jose E Batista, Heinz Kölbl, Sender Herschorn, Tomasz Rechberger, Javier Cambronero, Michael Halaska, Alex Coppell, Mathilde Kaper, Moses Huang, Emad Siddiqui, BEYOND study group

Urodynamics Unit, URD Hospital Quiron Teknon, Barcelona, Spain. , Department of General Gynecology and Gynecological Oncology, Medical University of Vienna, Austria. , Department of Surgery/Urology, University of Toronto, Toronto, Ontario, Canada. , II Department of Gynaecology, Medical University, Lublin, Poland. , Department of Urology, Infanta Leonor Hospital, Madrid, Spain. , Department of Obstetrics and Gynaecology, Charles University in Prague, Prague, Czech Republic. , Astellas Pharma Europe Ltd, Chertsey, Surrey. , Department of Biostatistics, Astellas Pharma Global Development, Leiden, Netherlands. , Astellas Pharma Europe Ltd, Chertsey, Surrey. , Astellas Pharma Europe Ltd, Chertsey, Surrey.

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