METHODS: In Phase III clinical trials in patients with
overactive bladder (OAB),
mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating the symptoms of OAB, including micturition frequency, urgency incontinence, and urgency. Significant improvements in micturition frequency, urgency incontinence, and mean volume voided/micturition were seen as early as the first assessment (week 4) for
mirabegron 50 and 100 mg, and were maintained throughout treatment. Responder analyses showed a significant improvement with
mirabegron 50 and 100 mg in terms of dry rates, ≥50% reduction in mean number of incontinence episodes/24 hr, and the proportion of patients with ≤8 micturitions/24 hr at final visit. The benefit of
mirabegron 50 and 100 mg was also evident in patients ≥65 years of age, and in both treatment-naïve patients and those who previously discontinued
antimuscarinic therapy. These data therefore demonstrate a clinically meaningful benefit with
mirabegron in the objective endpoints of OAB. Assessment of measures of health-related quality of life and treatment satisfaction showed that patients perceived treatment with
mirabegron as meaningful. In OAB clinical trials of up to 12 months
mirabegron appeared to be well tolerated. The most common adverse events (AEs) observed with
mirabegron in clinical trials of up to 12 months were
hypertension,
nasopharyngitis, and
urinary tract infection. The incidence of dry mouth was similar to placebo, and was between three and fivefold less than for
tolterodine extended release 4 mg. Since dry mouth is the most bothersome AE associated with
antimuscarinic drugs and often a reason for treatment discontinuation,
mirabegron may be a valuable treatment option for these patients.
CONCLUSIONS: In Phase III clinical trials,
mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating symptoms of OAB and, at doses of 50 and 100 mg, demonstrated significant improvements versus placebo on key secondary endpoints, as early as the first assessment (week 4), and these were maintained throughout treatment. In OAB clinical trials of up to 12 months,
mirabegron appeared to be well tolerated.