What is the indication for Vibegron (beta-3 adrenergic agonist)?

From the Guidelines

Vibegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. The standard dosage is 75 mg taken orally once daily with or without food. Vibegron works by selectively activating beta-3 adrenergic receptors in the detrusor muscle of the bladder, which promotes bladder relaxation during the storage phase of the urinary cycle. This mechanism increases bladder capacity and reduces symptoms like urgency, frequency, and incontinence episodes.

Key Points

• Vibegron is a beta-3 adrenergic agonist, similar to mirabegron, which has been studied extensively for the treatment of OAB symptoms 1.
• Unlike antimuscarinic medications also used for OAB, Vibegron typically causes fewer anticholinergic side effects such as dry mouth, constipation, and cognitive effects, making it a good option for elderly patients or those who cannot tolerate antimuscarinics.
• Patients should be advised that clinical improvement may take several weeks, and the medication should be continued as prescribed even if immediate results aren't observed.
• No dosage adjustment is needed for patients with mild to moderate renal or hepatic impairment, though caution is advised in severe cases.

Considerations

• The most frequent adverse events associated with beta-3 agonists like vibegron are hypertension, UTIs, headache, and nasopharyngitis 1.
• Vibegron does not affect voiding urodynamic parameters, and the overall change in post-void residual (PVR) is small, as observed with mirabegron 1.
• Long-term data on the efficacy and safety of vibegron in men of any age with LUTS are not available, but its mechanism and effects are expected to be similar to those of mirabegron, which has been more extensively studied 1.

From the FDA Drug Label

1. Indications and Usage GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults [see Clinical Studies (14.1)].

The indication for Vibegron is the treatment of overactive bladder (OAB) with symptoms of:

• Urge urinary incontinence
• Urgency
• Urinary frequency in adults 2.

From the Research

Indication for Vibegron

Vibegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. The following points summarize the indication for vibegron:

• Vibegron is a beta-3 adrenergic agonist that has been shown to be effective in reducing symptoms of OAB, including micturitions, urgency episodes, and urge incontinence episodes 3, 4, 5, 6, 7.
• The medication has been approved for use in Japan (2018) and the United States (2020) for the treatment of OAB 6, 7.
• Clinical trials have demonstrated the efficacy and safety of vibegron in patients with OAB, including those with wet and dry OAB 3, 4, 5, 7.

Key Benefits of Vibegron

Some key benefits of vibegron include:

• Effective in reducing symptoms of OAB, including micturitions, urgency episodes, and urge incontinence episodes 3, 4, 5, 6, 7.
• Well-tolerated with a favorable safety profile, including a low incidence of adverse events such as dry mouth and constipation 3, 4, 5, 7.
• Does not interact with cytochrome P450 enzymes, reducing the risk of drug interactions 6.
• Can be used in patients with polypharmacy, including older adults 6.

Patient Population

Vibegron is indicated for use in adult patients with OAB, including:

• Patients with wet OAB, characterized by urgency urinary incontinence 3, 4, 5, 6, 7.
• Patients with dry OAB, characterized by urgency and frequency without incontinence 3, 4, 5.
• Older adults, including those aged 65 years and older 6.