Adverse events associated with mirabegron 50 mg versus placebo: A systematic review and meta-analysis

Abstract

The safety of mirabegron 50mg monotherapy was comprehensively assessed versus placebo for overactive bladder. A systematic literature search was conducted up to June, 2020 using PUBMED, EMBASE and Cochrane Library. Randomized controlled trials evaluating safety of mirabegron in overactive bladder were collected, and safety was assessed according to 15 adverse events. Adverse events were widely selected to be assessed if they could be calculated. Heterogeneity among studies was assessed by using the χ2 test based on the Q and I2 tests. Pooled effect sizes were calculated using fixed model if I2<50%, otherwise a random-effects model was chosen. The outcomes were nasopharyngitis, dry mouth, hypertension, constipation, headache, dyspepsia, urinary tract infection, dizziness, blurred vision, nausea, cardiovascular events, influenza, electrocardiogram QT prolonged, upper respiratory tract infection and high blood pressure. In all, 10 peer-reviewed trials comprising 6135 patients were identified. Compared with placebo, mirabegron 50mg had an unfavorable safety profile resulting in nasopharyngitis (OR, 1.54[95% credible interval, 1.05-2.25]; P=0.03. No statistical difference was found between mirabegron 50mg and placebo groups in other 14 outcomes. Mirabegron 50mg is further confirmed to be nearly as safe as placebo, expect for nasopharyngitis. Nasopharyngitis is associated with mirabegron 50mg monotherapy for patients with overactive bladder.