Safety and efficacy of mirabegron: Analysis of a large integrated clinical trial database of patients with overactive bladder receiving mirabegron, antimuscarinics, or placebo
European Urology Oct 24, 2019
Chapple CR, Cruz F, Cardozo L, et al. - Pooled data investigated from ten phase 2–4, double-blind, 12-wk mirabegron monotherapy studies in adults with overactive bladder (OAB) who had received one or more doses of study drug was enrolled in order to summarise safety and efficiency reporting of mirabegron treatment for OAB symptoms. In the elderly vs younger age groups and in men vs women, across treatment groups, baseline hypertension and diabetes were more prevalent. Between treatment groups, within genders, frequencies were comparable. In baseline features, some variations, including the type of incontinence and medical history between genders, were noted. No formerly unreported safety concerns were recognized. In all treatment groups, betterments in efficiency vs placebo were seen. Important treatment-by-subgroup interactions involved the shift from baseline in the mean number of incontinence episodes/24 h by age (< 65 vs ≥ 65 yr), nocturia by age (< 65 vs ≥ 65 yr and < 75 vs ≥ 75 yr), and urgency episodes by former OAB medication. Hence, in adults of various age groups and genders, data from this integrated database of ten mirabegron studies reaffirm the safety and efficiency characterizations of mirabegron, solifenacin, and tolterodine.
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