From the FDA Drug Label
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. GEMTESA is a prescription medicine used to treat the following symptoms due to a condition called overactive bladder in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH): urge urinary incontinence: a strong need to urinate with leaking or wetting accidents urgency: the need to urinate right away frequency: urinating often
Gemtesa Medication: Gemtesa (vibegron) is a beta-3 adrenergic agonist used to treat overactive bladder (OAB) symptoms, including:
- Urge urinary incontinence
- Urgency
- Urinary frequency in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH) 1 1.
From the Research
Gemtesa (vibegron) is a highly effective and safe treatment option for overactive bladder (OAB) in adults, with a standard dose of 75 mg taken once daily with or without food, as evidenced by the most recent and highest quality study 2.
Mechanism of Action and Efficacy
Gemtesa works by selectively blocking beta-3 adrenergic receptors in the bladder muscle, causing the bladder to relax and increasing its capacity to hold urine. This mechanism differs from older anticholinergic medications and typically results in fewer side effects like dry mouth and constipation. The efficacy of vibegron has been demonstrated in several studies, including a post hoc analysis of a randomized, double-blind, placebo-controlled phase 3 study, which showed that vibegron significantly improved urinary parameters, including micturition number, urgency episodes, and incontinence episodes, in patients with OAB 2.
Safety and Tolerability
Vibegron has been shown to be safe and well-tolerated, with common side effects including headache, nasal congestion, diarrhea, nausea, and upper respiratory tract infections. A dedicated ambulatory blood pressure monitoring study showed that treatment with vibegron was not associated with clinically meaningful effects on blood pressure or heart rate 3.
Quality of Life and Patient Satisfaction
Vibegron has been shown to improve quality of life and patient satisfaction, as measured by the King's Health Questionnaire (KHQ) and the Patient Global Impression (PGI) scale, respectively 2. Patients with severe kidney or liver problems should consult their doctor about possible dose adjustments.
Comparison to Other Treatments
Vibegron has been compared to other treatments for OAB, including anticholinergic medications, and has been shown to have a favorable safety profile and equivalent efficacy in patients with mixed urinary incontinence (MUI) and urgency urinary incontinence (UUI) 2.
Key Points
- Gemtesa (vibegron) is a prescription medication used to treat OAB in adults
- Standard dose is 75 mg taken once daily with or without food
- Works by selectively blocking beta-3 adrenergic receptors in the bladder muscle
- Efficacy and safety have been demonstrated in several studies, including a post hoc analysis of a randomized, double-blind, placebo-controlled phase 3 study 2
- Common side effects include headache, nasal congestion, diarrhea, nausea, and upper respiratory tract infections
- Improves quality of life and patient satisfaction, as measured by the KHQ and PGI scale, respectively 2