Abstract
BackgroundMirabegron is a β3-adrenoreceptor agonist developed for treatment of overactive bladder (OAB). α1-Adrenergic receptor blockers are effective for lower urinary tract symptoms (LUTS) in male patients. However, the efficacy of mirabegron additional treatment in elderly male patients with persistent male LUTS, especially in OAB after monotherapy with α1-adrenergic blockers, is not fully understood.MethodsThis study was conducted in male LUTS patients who were ≥ 65 years of age and had persistent OAB symptoms, regardless of whether they took an α1-adrenergic receptor blocker orally. Before and 12 weeks after mirabegron additional therapy (50 mg once daily), we evaluated the efficacy of this treatment using the Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score (IPSS), and changes in the maximum flow rate (Qmax) and post-void residual urine volume (PVR). We evaluated patients overall and divided into two groups by age: young-old (from 65 to 74 years old) and old-old (from 75 to 84 years old).ResultsFifty men were enrolled in this study. Mirabegron additional therapy improved the total OABSS, total IPSS, and IPSS-quality of life (QOL) score. The voided volume (VV) and Qmax improved after treatment in patients overall. However, there was no significant change in PVR. The total OABSS, total IPSS, and IPSS-QOL score significantly improved in both of the young-old and old-old groups. However, a significant increasing of VV was detected in the young-old group. There were no significant differences in the Qmax or PVR in either group.ConclusionsMirabegron additional therapy was effective for male patients whose persistent LUTS and particularly OAB was not controlled with α1-adrenergic receptor blocker monotherapy, and mirabegron did not have negative effects on voiding function. Additionally, mirabegron additional therapy was considered effective regardless of patient age.Trial registrationTrial registration number (TRN) trial registration number (TRN) and date of registration: ISRCTN16759097 in July 8, 2016.
Highlights
Mirabegron is a β3-adrenoreceptor agonist developed for treatment of overactive bladder (OAB). α1-Adrenergic receptor blockers are effective for lower urinary tract symptoms (LUTS) in male patients
The present study is the first to focus on the efficacy of mirabegron additional therapy in elderly male patients with OAB after treatment with α1adrenergic receptor blocker monotherapy
Before and 12 weeks after mirabegron (Betanis®, Astellas Pharma Inc., Tokyo, Japan; 50 mg once daily) treatment was added to a previous α1-adrenergic receptor blocker for urinary symptoms, we evaluated the efficacy of the treatment using the Overactive Bladder Symptom Score (OABSS) and International Prostate Symptom Score (IPSS) to assess subjective symptoms, and we used uroflowmetry and post-void residual urine volume (PVR) to assess objective symptoms
Summary
Mirabegron is a β3-adrenoreceptor agonist developed for treatment of overactive bladder (OAB). α1-Adrenergic receptor blockers are effective for lower urinary tract symptoms (LUTS) in male patients. Α1-Adrenergic receptor blockers are effective for lower urinary tract symptoms (LUTS) in male patients. The efficacy of mirabegron additional treatment in elderly male patients with persistent male LUTS, especially in OAB after monotherapy with α1-adrenergic blockers, is not fully understood. Overactive bladder (OAB) is defined as a condition with characteristic symptoms of urinary urgency that is usually accompanied by frequency and nocturia, with or without urgency incontinence [1]. Mainly due to the adverse effects of antimuscarinic drugs, Japanese clinical guidelines for both male lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia recommend physicians to use α1adrenergic blockers as the first choice drug for male LUTS patients regardless of the presence or absence of OAB symptoms [8, 9]
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