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.

Efficacy and safety of tamsulosin vs its combination with mirabegron in the management of lower urinary tract non‐neurogenic overactive bladder symptoms (OABS) because of Benign Prostatic Enlargement (BPE)‐An open label randomised controlled clinical study

“…Size stratification of the prostate too was not considered in this study bearing in mind that bothersome LUTS are usually largely independent of prostate size. Considering the longer duration (12 weeks) of other Mirabegron published trials 26,27 one could question our shorter duration of study. For reasons described previously the present 8‐week follow‐up was performed in this protocol considering the fact that both drugs in the study had rapid onset of action and majority of their usual side effects if any would be exhibited well within this time frame.…”

“…We did not attempt examine the effect of Mirabegron in patients of OABS without BPE in this study, however, in a post‐marketing study by Takahashi et al 26 using 12 week Mirabegron therapy for OABS patients [with/without BPH on 4540 (3176 diagnosed with BPE)] in which the occurrences of AUR and the concomitant use of α1‐blockers were specifically investigated, the authors concluded that Mirabegron was well‐tolerated and effective for majority of their patients with OABS with or without concomitant BPE 26 . In a multicentre, randomised, double‐blind, placebo‐controlled, parallel comparison phase IV mirabegron study by Shin et al 27 conducted exclusively on 464 males with OABS the authors concluded that mirabegron was well tolerated for 26 weeks, without additional adverse effects compared with placebo.…”

Effect of systemic atherosclerosis on overactive bladder symptoms in men with benign prostatic hyperplasia

“…The diagnosis of BPH is clinically and academically defined in various ways, and IPSS, PV, and rectal examination are used as diagnostic criteria in various papers 12‐14 . Due to the nature of the research conducted on patients at the health promotion center, benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS) was defined as an IPSS of eight points or higher to classify patient groups based on IPSS.…”

Decompensated Urinary Bladder Due to Benign Prostatic Hyperplasia (Literature Review)

“…ДГПЗ може спричи-няти ГСМ внаслідок холінергічної денервації детрузора та послідовної гіперчутливості мускаринових рецепторів до ацетилхоліну. Порушення детрузора СМ може бути також наслідком ішемії, збільшення вмісту колагену в детрузорі, змін електричних властивостей гладком'язових клітин та реорганізації спінального рефлексу сечовипускання Після усунення обструкції відбувається реіннервація СМ і відновлення стабільності детрузора [20].…”