title: Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder in a Real-World Clinical Setting: A Japanese Post-Marketing Study.
abstract: OBJECTIVE
  To provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with the β3-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 Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score-Quality of Life (I-PSS QoL) surveys at Baseline and 12 weeks. Data were collected between April 2012 and July 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% α1-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 Baseline in the mean OABSS, and the I-PSS QoL decreased significantly from Baseline (-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 Japanese patients with OAB.
authors.affiliation: Medical Science, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Yumiko
authors.initials: Y
authors.lastname: Nozawa
authors.affiliation: Medical Science, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Kato
authors.affiliation: Medical Research, Medical Affairs, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Tabuchi
authors.affiliation: Japan-Asia Data Science, Development, Astellas Pharma Inc., Tokyo, Japan.
authors.forename: Kentarou
authors.initials: K
authors.lastname: Kuroishi
mesh_terms: D000083:Acetanilides / Q000008:administration & dosage* / Q000009:adverse effects; D058667:Adrenergic beta-3 Receptor Agonists / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D048909:Diabetes Complications / Q000150:complications; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011470:Prostatic Hyperplasia / Q000150:complications; D011788:Quality of Life; D012720:Severity of Illness Index; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy*; D016055:Urinary Retention / Q000209:etiology; D064804:Urological Agents / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000083:Acetanilides; D058667:Adrenergic beta-3 Receptor Agonists; D013844:Thiazoles; D064804:Urological Agents; C520025:mirabegron
keywords: mirabegron; overactive bladder; post-marketing survey; β3-adrenoceptor agonist