Safety and effectiveness of mirabegron in male patients with overactive bladder with or without benign prostatic hyperplasia: A Japanese post-marketing study


Abstract

Objectives: The aim of this post hoc analysis from the Japanese mirabegron surveillance program was to investigate the safety and effectiveness of mirabegron in male patients with overactive bladder (OAB) symptoms with/without concomitant benign prostatic hyperplasia (BPH).

Methods: This 12-week study included patients who were starting mirabegron treatment for the OAB symptoms of urinary urgency, daytime frequency, and urgency urinary incontinence. Patients were stratified according to BPH diagnosis, and patients with BPH were stratified into those who did/did not receive BPH-specific treatment. Assessments included adverse drug reactions (ADRs), residual urine volume evaluations, and total Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score-Quality of Life (IPSS-QoL) measurements.

Results: Of 4540 male patients, 3176 (70.0%) had been diagnosed with BPH. Mean age was slightly higher in patients with BPH (74.7 ± 8.41 years) versus patients without BPH (71.0 ± 12.13 years). Overall, 66/1364 (4.84%), 170/2588 (6.57%), and 35/569 (6.15%) patients without BPH, with BPH + treatment, and with BPH + no treatment, respectively, experienced ≥1 ADR. No patients without BPH and 21/3176 (0.66%) patients with BPH experienced a urinary retention ADR. No significant changes from baseline to week 12 in residual volume were noted. Mirabegron was judged to be an effective treatment for 990/1296 (76.4%) patients without BPH, 1935/2491 (77.7%) patients with BPH + treatment, and 421/538 (78.3%) patients with BPH + no treatment. Significant decreases in total OABSS and IPSS-QoL were observed for all groups.

Conclusions: Mirabegron was a well-tolerated and effective treatment for patients with OAB symptoms with or without BPH in this post-marketing study.

Keywords: benign prostatic hyperplasia; effectiveness; mirabegron; overactive bladder; safety.

Conflict of interest statement

Satoru Takahashi has received consultancy, lectureship, and advisory board member fees and nonfinancial support from Astellas Pharma Inc. and consultancy and lectureship fees from Pfizer, Nihon Shinyaku, Kyorin, Kissei, Daiichi Sankyo, Taiho, and Hisamitsu. Daisuke Kato, Hiromi Tabuchi, and Satoshi Uno are all employees of Astellas Pharma Inc.

Figures

FIGURE 1
FIGURE 1
Changes from baseline to week 12 (or time of discontinuation) in residual urine volume. Data are shown for the safety analysis set. Results are expressed in terms of mean?±?SD. P values were derived using the Wilcoxon signed rank test. aIncludes data from seven patients with unknown BPH treatment status. bPatients received treatment with an α1‐blocker and/or 5α‐reductase inhibitor. BPH, benign prostatic hyperplasia; OAB, overactive bladder; SD, standard deviation
FIGURE 2
FIGURE 2
Changes from baseline to week 12 (or time of discontinuation) in total OABSS. Data are shown for the OABSS analysis set. Results are expressed in terms of mean?±?SD. P values were derived using the Wilcoxon signed rank test. aIncludes data from nine patients with unknown BPH treatment status. bPatients received treatment with an α1‐blocker and/or 5α‐reductase inhibitor. BPH, benign prostatic hyperplasia; OAB, overactive bladder; OABSS, Overactive Bladder Symptom Score; SD, standard deviation
FIGURE 3
FIGURE 3
Changes from baseline to week 12 (or time of discontinuation) in IPSS‐QoL. Data are shown for the efficacy analysis set. Results are expressed in terms of mean?±?SD. P values were derived using the Wilcoxon signed rank test. aIncludes data from 12 patients with unknown BPH treatment status. bPatients received treatment with an α1‐blocker and/or 5α‐reductase inhibitor. BPH, benign prostatic hyperplasia; IPSS‐QoL, International Prostate Symptom Score‐Quality of Life; OAB, overactive bladder; SD, standard deviation
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