Betmiga (mirabegron), 50 mg modified release tablets, is a beta 3-adrenoceptor agonist authorised for symptomatic treatment of adults with urgency, increased urinary frequency and/or urge incontinence. The effect is shown for 12 weeks and is just as modest as for antimuscarinic agents. When the placebo effect is taken into account, patients in treatment with mirabegron experience a reduction of approximately 0.4 incontinence episodes and 0.6 fewer micturitions per day. Equal numbers of patients experience adverse events from using mirabegron or antimuscarinic agents. Dry mouth is a less frequent adverse event in patients who use mirabegron compared to antimuscarinic agents. The safety profile is best described for the antimuscarinic agents.
It is IRF's overall assessment that the indication for using urologic spasmolytics should be considered carefully due to the modest effect associated with all the agents. If there is any indication for medical treatment, the choice of product should be based on the safety profile and treatment price.
Betmiga is subject to general reimbursement as from 18 February 2013.