Drug updated on 9/4/2024
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
Summary
- Gemtesa (vibegron) is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Reduction in Incontinence: Vibegron demonstrated a significantly greater reduction in total urinary incontinence episodes compared to mirabegron and tolterodine over 52 weeks.
- Mean Voided Volume/Micturition: Vibegron was more effective than mirabegron in increasing mean voided volume per micturition, with significantly greater improvements noted at 12 and 52 weeks.
- Comparative Effectiveness: Solifenacin 10 mg was the most effective in reducing mean daily micturitions and incontinence episodes, while fesoterodine 8 mg and oxybutynin 5 mg showed superior outcomes in reducing urgency incontinence episodes and increasing voided volume/micturition, respectively.
- Both vibegron and mirabegron demonstrated safety profiles similar to placebo, with the exception that mirabegron was associated with a higher incidence of nasopharyngitis and cardiovascular adverse events.
- Common adverse events reported for vibegron and mirabegron included hypertension, urinary tract infection, headache, and nasopharyngitis. Vibegron specifically showed a significantly increased incidence of hypertension compared to placebo.
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 |