Vibegron

(Gemtesa®)

Vibegron

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Drug updated on 5/17/2024

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.

Summary
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  • 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.