Mirabegron confirmed safe and effective for overactive bladder syndrome

Mirabegron may be used to effectively treat overactive bladder (OAB) syndrome without presenting new and pressing safety concerns, a recent study has found.

Pooling from 10 phase 2–4 double-blind, 12-week mirabegron trials, researchers reassessed the efficacy and safety of the drug against OAB syndrome. Safety was evaluated through the occurrence of treatment-emergent adverse events (TEAEs), while bladder diary data were used for the assessment of treatment efficacy.

Both the 25-mg and 50-mg doses of mirabegron significantly improved OAB symptoms relative to placebo. For instance, the mean number of 24-hour incontinence episodes dropped from 2.95±0.10 and 2.51±0.05 at baseline to 1.35±0.08 and 1.10±0.05 at end-of-treatment for either dose, respectively. The change observed with placebo, in comparison, was statistically smaller.

A similar effect was reported for the number of micturitions per 24 hours. Mirabegron 25 and 50 mg induced a decrease of 2.05±0.08 and 2.12±0.04 episodes from baseline to end-of-treatment, respectively, both significantly greater than the placebo treatment’s net change of –1.55±0.05. The same was true for urgency and nocturia episodes per 24 hours.

The mean voided volume was significantly increased after treatment with 25-mg (change, 15.94±1.37) and 50-mg (change, 23.17±0.84) mirabegron, likewise statistically outperforming placebo.

These improvements did not come with new safety signals. TEAEs included dry mouth, constipation, urinary tract infection, tachycardia and treatment-emergent hypertension. However, these occurred more commonly in patients treated with antimuscarinics vs mirabegron. Placebo treatments showed the lowest incidence of TEAEs.