Vibegron

(Gemtesa®)

Gemtesa®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 75 mg)
Drug ClassBeta-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.

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Summary
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  • 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.