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

Abstract

PURPOSE:The efficacy and safety of βeta-3 agonists (Mirabegron 50 mg) have been sparingly assessed in the published English literature. We aim to do an efficacy-safety analysis of Mirabegron-Tamsulosin combination therapy vs tamsulosin-placebo monotherapy in a select subset of medication virgin Benign Prostatic Enlargement (BPE) patients with coexisting predominant non-neurogenic overactive bladder symptoms (OABS). METHODS:After prior written informed consent and IEC, 80 patients of uncomplicated BPE with coexisting non-neurogenic OABS and IPSS of >7 without contraindications to drug therapy were computer randomised/allocated to receive either[50 mg Mirabegron plus Tamsulosin 0.4 mg (Intervention arm-I)]or [Tamsulosin 0.4 mg plus capsule lactobacillus (Comparator arm-II)] once daily for 8 weeks. Efficacy was evaluated using the OABS Score (OABSS), mean change in nocturnal frequency (NF), PVR and IPSS, while safety was assessed by recording treatment emergent adverse events (TEAE). Follow-up visits were performed at second, fourth and eighth week. RESULTS:Patient data in both groups were generally comparable with the exception of NF and IPSS storage sub score (IPSS-ss). Significant improvements were visualised in the eighth week primary endpoint total OABS sub score (OABSS-ss) in the combination group (P < .001).Similar significant improvements were seen with most secondary parameters such as the mean change in NF, IPSS, IPSS-ss, OABS-ss, voided volume, Qmax, and Quality of life index (QOL) (P < .001). No significant increase in PVR was observed in the Mirabegron arm and no patient developed urinary retention. The TEAE were minor, self-limiting and managed symptomatically without drug discontinuity. CONCLUSION:Mirabegron can be significantly efficacious and safe in ameliorating non-neurogenic OABS induced by BPE vs placebo by initiating combination therapy from the start as opposed to the usual 'add on therapy' protocol. This combination How to cite this article: Singh I, Behera DP, T.K. A, Gupta S. 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. Int J Clin Pract.

Mirabegron Add-On Tamsulosin for Men with Overactive Bladder Symptoms: A Pooled Analysis of Four Randomized Controlled Trials

“…Two studies were from the same clinical trial (gov: NCT02757768) or MATCH trial. Finally, four RCTs were selected for the analysis [11][12][13][14]. The four RCTs comprised 1,397 patients with OAB or OABS (Fig.…”

“…The trial by Ichihara et al [11] exhibited a high risk of selection bias in allocation concealment. Two trials were open-labeled with high risks of performance bias and detection bias [11,14]. The RCT by Kaplan et al [12] exhibited attrition and reporting biases.…”

“…Mirabegron exhibits better efficacy and fewer adverse effects and is thus superior to antimuscarinic agent in the treatment of OABS. Related studies have shown that mirabegron combined with tamsulosin is superior to mirabegron monotherapy for treating patients with concomitant OABS and BPH [7,[11][12][13][14][15]. Additionally, the rational use of mirabegron additional therapy reduces healthcare resources and improves QOL of patients with OABS [20].…”

“…β3-AR agonists combined with anticholinergics or α1Bs were reported to be more effective than monotherapy due to differences in the mechanism of action between drugs used alone and in combination [10]. Several studies have analyzed the efficacy and safety of mirabegron add-on therapy to tamsulosin in patients with OABS [11][12][13][14]. Mirabegron treatment in men with persistent LUTS and uncontrollable OABS after α1B monotherapy was proved to be effective, with no effect on the voiding function [15].…”

Unraveling the impact of Lactobacillus spp. and other urinary microorganisms on the efficacy of mirabegron in female patients with overactive bladder

“…The primary goal of treating OAB is to alleviate symptoms and improve quality of life, and medication remains the preferred treatment for the vast majority of patients ( Deeks, 2018 ). Mirabegron has proven effective as a first-line drug in treating OAB in several clinical trials ( Herschorn et al., 2013 ; Kuo et al., 2015 ; Singh et al., 2021 ). However, the efficacy of mirabegron varies widely, and the reasons for this variation remain unclear.…”