Drug updated on 3/28/2024
| Dosage Form | Tablet (oral: 75 mg) |
| Drug Class | Beta-3 adrenergic agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Summary
- Vibegron (Gemtesa) is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
- Three systematic reviews/meta-analyses were reviewed to gather information about Gemtesa's efficacy and safety profile.
- According to a study that indirectly compared vibegron and mirabegron, both drugs were found more efficacious than placebo at reducing OAB symptoms such as micturition frequency, incontinence, urgency, nocturia but vibegron was superior at reducing mean voided volume per micturition.
- A long-term network meta-analysis showed that after 52 weeks of treatment with vibegron there was significantly greater reduction in daily total urinary incontinence episodes when compared to mirabegron or tolterodine; however no significant differences were observed between these treatments regarding daily micturitions or volume voided per micturition.
- In an indirect comparison study involving phase 3 trials data on β3-adrenergic agonists including vibergon and mirabergon for treating OAB patients it was noted that improvement seen by using Gemtesa on total urine continence episodes versus Mirabregon lasted up until week 52 while improvements on volume voided persisted till week 12 only; incidence rates for adverse events like hypertension appeared comparable across all three treatments - Vibergon, Mirabregon & Tolterodine during long term trials.
- Safety outcomes from the studies indicate similar profiles between gemtesa and placebo groups except higher risk associated with nasopharyngitis & cardiovascular adverse events reported specifically under use of Mirbegorn ; most common side effects reported among anticholinergic users included dry mouth whereas hypertension seemed prevalent amongst β3-adrenergic agonists users.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gemtesa (vibegron) Prescribing Information. | 2020 | Urovant Sciences, Inc., Irvine, CA |