Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 75 mg) |
Drug Class | Beta-3 adrenergic agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Latest News
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Summary
- Vibegron (Gemtesa) is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. It has demonstrated superior efficacy compared to other drugs such as mirabegron and tolterodine, particularly in reducing daily total urinary incontinence episodes and improving mean voided volume per micturition.
- Four studies were reviewed which provided information on vibegron's effectiveness against OAB. Both vibegron and mirabegron outperformed placebo treatments by significantly reducing the frequency of micturition, incontinence, urgency, urgency-incontinence, and nocturia.
- The safety profiles of vibegron are comparable to those of mirabegron; both drugs are generally well-tolerated. However, unlike mirabegron, which was associated with a higher risk for nasopharyngitis and cardiovascular adverse events than placebo, no specific risks were highlighted for vibegron.
- Common adverse events reported include hypertension, urinary tract infection, headache, and nasopharyngitis among β3-adrenergic agonists like vibegron and mirabegron, while anticholinergics showed a different profile, including dry mouth, constipation, blurred vision, and hypertension being most common.
- No detailed subgroup considerations based on age, gender, or comorbid conditions were provided within these studies. Instead, they focused more broadly on efficacy comparisons across the adult population diagnosed with OAB.
- Based upon these findings, it can be concluded that Gemtesa may offer an effective balance between symptom control efficiency along with a manageable safety profile. This makes it a beneficial treatment option, especially where increasing bladder volume is a priority or when concerned about certain adverse effects associated with other medications like mirabegron.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Gemtesa (vibegron) Prescribing Information. | 2023 | Urovant Sciences, Inc., Irvine, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of vibegron compared with mirabegron for overactive bladder: a systematic review and network meta-analysis. | 2023 | Lower Urinary Tract Symptoms |
Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis. | 2023 | International Brazilian Journal of Urology |
Long-term efficacy and safety of vibegron versus mirabegron and anticholinergics for overactive bladder: a systematic review and network meta-analysis. | 2022 | Drugs in Context |
Efficacy of vibegron and mirabegron for overactive bladder: a systematic literature review and indirect treatment comparison. | 2021 | Advances in Therapy |