Mirabegron 25mg modified-release tablets

Abstract Background Ureteral stent insertion, crucial for managing ureteral obstructions, often results in stent‐related symptoms (SRSs) adversely affecting patient quality of life. This meta‐analysis compares the effectiveness of tamsulosin or mirabegron versus placebo in alleviating these symptoms. Methods Following PRISMA guidelines, we systematically reviewed randomized controlled trials (RCTs) comparing mirabegron or tamsulosin to placebo in managing SRSs. Data sources included PubMed, Embase, Web of Science and CENTRAL, up to November 2023. The inclusion criteria focused on studies reporting on Ureteral Stent Symptom Questionnaire (USSQ), International Prostate Symptom Score (IPSS), quality of life (QoL) assessments, analgesic usage and adverse events. Meta‐analysis employed a random‐effects model, assessing heterogeneity and publication bias. For assessing the risk of bias in the included randomized trials, we employed the Cochrane Collaboration's tool. This protocol was registered at the International Prospective Register of Systematic Reviews (registration number: CRD42024511842). Results Sixteen RCTs with 1635 patients met the inclusion criteria. Tamsulosin significantly improved body pain (MD −1.80; 95% CI −3.53 to −0.07; p = 0.04), sexual function (MD −0.63; 95% CI −1.16 to −0.10; p = 0.02) and improved quality of life score (MD −2.36; 95% CI −3.56 to −1.17; p = 0.0001), while mirabegron was more effective in reducing urinary symptoms (MD −8.71; 95% CI −15.81 to −1.61; p = 0.02), enhancing general health (MD −2.58; 95% CI −3.78 to −1.37; p < 0.0001) and reducing analgesia use (MD −1.56; 95% CI −2.70 to −0.41; p = 0.008). Both medications significantly reduced total International Prostate Symptom Score (Tamsulosin MD −8.4; 95% CI −15.63 to −1.22; p = 0.02; Mirabegron MD −6.29; 95% CI −8.50 to −4.08; p < 0.00001) without a significant rise in adverse events (tamsulosin OR 1.90; 95% CI 0.40–9.18; mirabegron p = 0.42 and OR 0.93; 95% CI 0.30–2.88; p = 0.89). Conclusions Tamsulosin and mirabegron effectively manage SRSs, with distinct benefits in different symptom domains. This suggests a potential for complementary therapeutic strategies. Future high‐quality RCTs are needed to explore their combined efficacy.

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PURPOSE: Non-neurogenic overactive bladder (OAB) is a common problem in children. Antimuscarinics have been widely used as first-line medical treatment. However, their frequent side effects necessitate searching for therapeutic alternatives. We aimed to assess the efficacy and safety of the beta 3 agonist, mirabegron. MATERIALS AND METHODS: A randomized controlled trial enrolled child with non-neurogenic OAB refractory to behavioral urotherapy. Patients were randomized to receive either Mirabegron 25/50 mg based on a 40-kg body weight cutoff or solifenacin 5 mg for 12 weeks. Patients were assessed using Dysfunctional Voiding Scoring System questionnaire (DVSS), 3-day voiding diary and uroflowmetry. Vital signs and adverse effects were recorded at baseline and follow-up. The study primary endpoint was ≥50% reduction of the baseline DVSS. RESULTS: Among 128 patients screened, 72 patients (36 in each group) completed the study with a mean age of 9.2±2.3 years. Both groups had significant improvement of DVSS and voiding diary (p<0.001) at 12 weeks. In mirabegron group, 94.4% (34/36) had greater than 50% improvement of DVSS compared to 75% (27/36) of solifenacin group (P=0.02). Complete symptom resolution was observed in 22.2% (8/36) patients on mirabegron versus 8.3% (3/36) on solifenacin (P=0.1). Patients on mirabegron had less adverse effects (19.4% vs 47.2%; p=0.01). CONCLUSION: Mirabegron is more effective with fewer adverse effects than solifenacin for treatment of children with OAB. Mirabegron treatment improves daytime symptoms and nocturnal enuresis with less risk of constipation. It may be considered as first-line pharmacotherapy in this patient population.

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