Mirabegron, a novel, non-antimuscarinic drug for the overactive bladder: An up-to-dated review

Abstract

Mirabegron opened a new era in the treatment of overactive bladder (OAB). For the first time physicians dealing with OAB have an effective alternative to the pharmacological mainstay of the therapy for this disorder, the antimuscarinic drugs. This first-in-class, potent β3-adrenoceptors agonist has recently received approval by regulatory authorities in Japan, United States and Europe, based on the favourable efficacy-tolerability profile demonstrated in multiple randomized, multinational, controlled trials, both short and long-term. There is substantial consistency through the studies in reporting the cardiovascular safety of treatment with mirabegron. The main advantage of mirabegron is the placebo-like incidence of classic adverse effects caused by antimuscarinics, dry mouth and constipation, that is expected to improve long-term adherence of patients to treatment. Mirabegron can be used in patients with contraindications to antimuscarinics and in those who discontinued previous antimuscarinic therapy. Herein, we reviewed the published literature on mirabegron, focusing on the rationale of β3-agonism for OAB treatment and on the preclinical and clinical evidence of efficacy and safety available on this new pharmacological principle.

Keywords: Mirabegron, β3-adrenoceptor agonist, Antimuscarinics, Overactive bladder, Urinary incontinence

Core tip: Mirabegron is a first-in-class, potent β3-adrenoceptors agonist that has been proven effective in the treatment of overactive bladder (OAB) based on multiple randomized multinational trials. The safety-tolerability profile of treatment with mirabegron has been extensively studied. The placebo-like incidence of classic adverse effects caused by antimuscarinics should improve long-term adherence to treatment with this new drug. Mirabegron can be an alternative in patients with contraindications to antimuscarinics or that discontinued previous antimuscarinic therapy. An updated review of the rationale of β3-agonism for OAB treatment and evidence of efficacy and safety of mirabegron is presented.