PURPOSE: Many patients with OAB discontinue pharmacotherapy due to suboptimal efficacy or side effects.
Mirabegron, a β(3) -adrenoceptor agonist, may offer an effective and well-tolerated alternative treatment for OAB.
MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled trial was conducted in the United States and Canada. After a 2-week placebo run-in period, adults with OAB symptoms for ≥3 months were randomized 1:1:1 to receive placebo, mirabegron 50 or 100 mg once-daily for 12 weeks. Efficacy data were collected via patient-completed diaries and QOL assessments. Co-primary efficacy endpoints were changes from baseline to final visit in mean number of incontinence episodes/24 hours and micturitions/24 hours. Key secondary micturition and incontinence endpoints were also evaluated. Safety assessments included TEAEs, laboratory assessments, vital signs, electrocardiograms, and PVR volume.
RESULTS: Compared to placebo, mirabegron 50 and 100 mg groups demonstrated statistically significantly greater mean decreases [95% CI] from baseline for both incontinence episodes (-1.13[-1.35,- 0.91],- 1.47[-1.69,- 1.25], and -1.63[-1.86,- 1.40]) and micturitions [-1.05[-1.31,- 0.79],- 1.66 [-1.92, -1.40], and -1.75[-2.01,- 1.48]) /24 hours; p< 0.05). Significant improvements in all key secondary endpoints were observed for both mirabegron doses vs placebo. The incidence of frequently reported TEAEs (hypertension, urinary tract infection, headache, nasopharyngitis) was similar in mirabegron and placebo groups. Dry mouth was reported for 1.5%, 0.5%, and 2.1% of patients in the placebo, mirabegron 50 and 100 mg, groups, respectively.
CONCLUSIONS: Mirabegron 50 or 100 mg once-daily is an effective treatment for OAB symptoms, with a low occurrence of side effects.
Written by:
Nitti V, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Are you the author?
New York University Langone Medical Center, New York, New York.
Reference: J Urol. 2012 Oct 15. pii: S0022-5347(12)05216-0.
doi: 10.1016/j.juro.2012.10.017
PubMed Abstract
PMID: 23079373
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