Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder in a Real‐World Clinical Setting: A J apanese Post‐Marketing Study

Objectives To provide real‐world data on J apanese patients with overactive bladder ( OAB ) initiating treatment with the β 3 ‐adrenoceptor agonist, mirabegron. This study examined prescribing patterns, adverse drug reaction ( ADR ) incidence, and treatment effectiveness. Methods Full medical histories, including prior/concomitant drug use, were collected before initiating mirabegron treatment. After 12 weeks mirabegron, physicians assessed ADR incidence and treatment effectiveness. Residual urine volume was assessed and patients completed the O veractive B ladder S ymptom S core ( OABSS ) and I nternational P rostate S ymptom S core‐ Q uality of L ife ( I‐PSS QoL ) surveys at B aseline and 12 weeks. Data were collected between A pril 2012 and J uly 2014. Results Of 9795 OAB patients (46.8% male; 80.8% ≥65 years), 71.7% had coexisting disease [notably benign prostatic hyperplasia ( BPH , 32.4%), hypertension (31.9%), and diabetes mellitus (9.4%)] and 53.4% reported concomitant drug use (27.8% α 1 ‐antagonists, 6.3% anticholinergics). The incidence of total ADRs was 6.07% [including constipation (0.97%), thirst (0.47%), and dysuria (0.44%)], of serious ADRs , 0.21%, of cardiovascular ADRs , 0.48% and of urinary retention, 0.31%. Incidence of total ADRs in patients with concomitant cardiovascular disease was 10.09% and of those related to urinary retention in men with untreated BPH , 0.88%. After 12 weeks treatment, physicians judged mirabegron as “effective” in 80.7% of patients, 63.6% of patients achieved the three‐point minimal clinically important change from B aseline in the mean OABSS , and the I‐PSS QoL decreased significantly from B aseline (−2.1 ± 1.77; P  < 0.001). Conclusions In the clinical setting, mirabegron is well tolerated, with no unanticipated ADRs , and is an effective treatment for J apanese patients with OAB .