Vibegron 75mg tablets

BACKGROUND: After the introduction of anticholinergic drugs for the treatment of overactive bladder (OAB), the discovery of β-adrenergic agonists has helped reduce the side effects associated with the former. Currently, the two available medications, mirabegron and vibegron, are β-adrenergic agonists. However, clinical practitioners are still faced with the dilemma of which drug to choose. OBJECTIVE: To analyze and compare the efficacy and adverse effects of the two medications. METHODS: A literature search was conducted to identify randomized controlled trials using mirabegron and vibegron for the treatment of OAB. Databases such as PubMed, Web of Science, Cochrane Library, and Embase were searched. The search cutoff date was July 25 2024. Data extraction and quality assessment were performed using standardized methods. A meta-analysis was then conducted using RevMan software and a random-effects model, with studies weighted according to sample size and variance. Heterogeneity was assessed using the I² statistic. All statistical analyses were performed using RevMan, and results were presented as effect sizes (e.g., mean difference or risk ratio). RESULTS: Three randomized controlled trials compared the safety and efficacy of mirabegron and vibegron head-to-head, involving 368 patients. The trials, each lasting 8 or 12 weeks. The trials compared the changes in various indices of the OABSS (Overactive Bladder Symptom Score) between the two drugs. The statistical methods used in the analysis included Mean Difference (MD), 95% Confidence Interval (CI), p-value, and I² statistic. For OABSS: MD = 0.38, 95% CI = - 0.19 to 0.95, p = 0.28, I² = 21%; for Q1: MD = 0.08, 95% CI = - 0.01 to 0.26, p = 0.31, I² = 4%; for Q2: MD = 0.08, 95% CI = - 0.21 to 0.37, p = 0.67, I² = 0%; for Q3: MD = 0.05, 95% CI = - 0.45 to 0.56, p = 0.90, I² = 0%; for Q4: MD = - 0.21, 95% CI = - 0.68 to 0.27, p = 0.35, I² = 0%. The relative risk (RR) of adverse effects between the two drugs was: RR = 0.87, 95% CI = 0.57 to 1.34, p = 0.27, I² = 25%; for constipation: RR = 0.73, 95% CI = 0.37 to 1.43, p = 0.27, I² = 25%; and for dry mouth: RR = 0.98, 95% CI = 0.42 to 2.30, p = 0.78, I² = 0%. CONCLUSION: There appears to be no statistically significant difference in efficacy and safety between mirabegron and vibegron for OAB patients. Further high-quality prospective studies are needed to confirm these results.

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BACKGROUND: This updated meta-analysis aimed to compare the efficacy, safety, and treatment adherence of mirabegron and vibegron in patients with overactive bladder with head-to-head trials. METHODS: A systematic literature search was conducted in PubMed, Embase, ClinicalTrials.gov, and the Cochrane Library from January 1, 2016 to July 6, 2025. Comparative studies evaluating mirabegron versus vibegron were included. Study selection followed the PICOS framework, and quality assessment was performed using the Cochrane Handbook for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale for non-RCTs. Outcomes included changes in voiding diary parameters, urodynamic measures, overactive bladder symptom scores, adverse events, and treatment adherence. Statistical analyses were conducted using Review Manager 5.3. RESULTS: Six studies met the inclusion criteria. Vibegron was associated with a greater reduction in daily urgency episodes (standardized mean difference [SMD] = 0.37, P = .0006) and urinary urge incontinence (UUI) episodes (SMD = 0.33, P = .006) compared to mirabegron. However, no significant differences were found in other efficacy parameters or overall safety profiles. Vibegron demonstrated better adherence, with a higher continuation rate and lower discontinuation rate. CONCLUSION: Recent data indicated that vibegron demonstrated superior efficacy in reducing urgency and UUI episodes while maintaining a safety profile comparable to mirabegron. Furthermore, vibegron is associated with improved treatment adherence. However, additional RCTs are necessary to confirm these findings.

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PURPOSE: -adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial. MATERIALS AND METHODS: Men ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary end points were change from baseline at week 12 in mean daily micturitions and urgency episodes. Secondary end points were change from baseline at week 12 in mean nightly nocturia and daily urge urinary incontinence episodes, International Prostate Symptom Score‒storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs). RESULTS: < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in ≥ 2% of participants were hypertension (9.0% vs 8.3%), COVID-19 (4.0% vs 3.1%), UTI (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%). CONCLUSIONS: In this trial, vibegron met all primary and secondary end points and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.

Abstract licence: CC BY-NC-ND

ABSTRACT Purpose Vibegron was associated with improvements in efficacy versus placebo and was well tolerated in men with overactive bladder (OAB) on pharmacotherapy for benign prostatic hyperplasia (BPH) in the COURAGE trial (NCT03902080). Additional safety, bladder function, and urodynamics data are provided. Methods This 24‐week, phase 3, double‐blind, placebo‐controlled trial randomized men ≥ 45 years with OAB and BPH receiving α‐blocker ± 5α‐reductase inhibitors to once‐daily vibegron or placebo (1:1). From the safety analysis set (SAF), postvoid residual urine volume (PVR), maximum urinary flow rate (Uroflow‐Q max ), International Prostate Symptom Score (IPSS) total score, and urologic‐related adverse events (AEs) were collected throughout the trial. Q max and detrusor pressure at Q max (P det Q max ) were collected at baseline and week 12 in a urodynamics substudy (urodynamics evaluable set [UES]). Results In the SAF, differences between vibegron ( n = 553) and placebo ( n = 551) in PVR and Uroflow‐Q max were minimal at baseline, week 12, and week 24. Mean (SD) change from baseline (CFB) at week 24 in IPSS total score was −7.3 (6.96) with vibegron and −5.7 (7.14) with placebo. Urinary retention was reported as an AE for 5 (0.9%) and 4 (0.7%) participants receiving vibegron and placebo, respectively. In the UES (vibegron, n = 21; placebo, n = 22), least squares mean difference (95% CI) between vibegron and placebo in CFB at week 12 was 2.75 (0.16, 5.34) mL/s in Q max and 2.86 (–13.52, 19.25) cmH 2 O in P det Q max . Conclusions There were no safety signals related to bladder function identified by urodynamics; risk of protocol‐defined AEs of urinary retention or residual urine volume increase was not increased with vibegron compared with placebo in this population. Clinical Trial Registration This study is registered at www.clinicaltrials.gov . The registration identification number is NCT03902080.

Abstract licence: CC BY-NC

Abstract Introduction Overactive bladder (OAB) is a prevalent and potentially debilitating syndrome that significantly impairs quality of life. Mirabegron and vibegron are β 3 -adrenoceptor (β 3 AR) agonists that provide a different mechanism of action to antimuscarinic medications. Vibegron has high β 3 AR selectivity and enhances detrusor relaxation without compromising voiding function. This review summarises the clinical and real-world evidence supporting the efficacy, safety and patient-reported benefits of vibegron in OAB. Methods A comprehensive search of the PubMed database was conducted in December 2024 using the keyword "vibegron". This search yielded 123 entries, which were subsequently screened by title for relevance to the objectives of this narrative review. All relevant articles identified through this process were included. Results Pivotal phase III trials have demonstrated significant reductions in urgency, urinary frequency and urgency urinary incontinence with vibegron, with rapid onset of action and a more favourable tolerability profile than antimuscarinics. The benefits of vibegron were consistent across diverse patient populations, including older adults and those with concomitant benign prostatic hyperplasia. Real-world data further suggest that vibegron is associated with improved adherence and persistence compared with other OAB therapies. Additionally, cardiovascular safety studies confirm that vibegron has no clinically significant effects on blood pressure or heart rate. While comparative trials with mirabegron indicate similar efficacy, vibegron’s higher β 3 AR selectivity and lack of cytochrome P450 interactions offer advantages in specific patient groups. Ongoing research, including real-world phase IV studies, aims to further define the long-term effectiveness and safety of vibegron in clinical practice. Conclusion Vibegron represents an important advance in the pharmacologic management of OAB, providing a well-tolerated and effective alternative to existing therapies.

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