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

Abstract

Objective: 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. Patients and methods: 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. Results: 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. Conclusions: 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.

Clinical efficacy and safety of mirabegron and imidafenacin in women with overactive bladder: A randomized crossover study (the MICRO study)

“…To our knowledge, this is the first study to compare the efficacy and safety between mirabegron and imidafenacin. We found that the efficacy of mirabegron was comparable with that of imidafenacin, which is consistent with previous wherein solifenacin 18 or tolterodine 8 were used as antimuscarinic agents. However, the safety of mirabegron treatment was superior to that of imidafenacin treatment due to certain antimuscarinic effects.…”

Comparative Efficacy and Tolerability of Antimuscarinic Agents and the Selective β3‐Adrenoceptor Agonist, Mirabegron, for the Treatment of Overactive Bladder: Which is More Preferable as an Initial Treatment?

“…The post hoc analysis of a randomized European‐Australian phase 3 trial showed that mirabegron had a numerically positive treatment effect on incontinence and micturition frequency in patients who discontinued prior antimuscarinics regardless of insufficient efficacy or poor tolerability as well as in those who were treatment‐naïve . Another phase 3 trial demonstrated that mirabegron was similarly efficacious to solifenacin in OAB patients dissatisfied with previous antimuscarinic treatment because of lack of efficacy . In real‐world situation, mirabegron achieved improvement of OAB symptoms in 60% of the patients who did not benefit from prior antimuscarinics and bladder drill .…”

Mirabegron in overactive bladder patients: efficacy review and update on drug safety

“…One randomized double blind phase IIIb noninferiority study enrolled 1887 patients who had failed antimuscarinic therapy and randomized them to solifenacin 5 mg or mirabegron 50 mg for 12 weeks [Batista et al 2015]. The primary efficacy endpoint was change in baseline to end of study in mean number of micturitions per 24 hours.…”