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

Low Urin Tract Symptoms. 2018 May;10(2):122-130. doi: 10.1111/luts.12148. Epub 2016 Nov 17.


Objectives: 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.

Keywords: mirabegron; overactive bladder; post-marketing survey; β3-adrenoceptor agonist.

Publication types

  • Multicenter Study

MeSH terms

  • Acetanilides / administration & dosage*
  • Acetanilides / adverse effects
  • Adrenergic beta-3 Receptor Agonists / administration & dosage*
  • Adult
  • Aged
  • Aged, 80 and over
  • Diabetes Complications / complications
  • Drug Administration Schedule
  • Female
  • Humans
  • Hypertension / complications
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing
  • Prostatic Hyperplasia / complications
  • Quality of Life
  • Severity of Illness Index
  • Thiazoles / administration & dosage*
  • Thiazoles / adverse effects
  • Treatment Outcome
  • Urinary Bladder, Overactive / complications
  • Urinary Bladder, Overactive / drug therapy*
  • Urinary Retention / etiology
  • Urological Agents / administration & dosage*
  • Urological Agents / adverse effects


  • Acetanilides
  • Adrenergic beta-3 Receptor Agonists
  • Thiazoles
  • Urological Agents
  • mirabegron