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Can men take Gemtesa?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on May 31, 2024.

Official answer

by Drugs.com

Yes, men can take Gemtesa (vibegron) for the treatment of overactive bladder (OAB). Overactive bladder is a condition that causes symptoms of urinary incontinence, urgency, and frequency. Gemtesa is available as tablets that are taken once a day, with or without food. It was approved by the FDA in December 2020.

In a clinical trial that included 1,085 adults, the majority of patients were female (85%). However, the study also included males. Researchers were not able to determine the difference in effectiveness of Gemtesa for OAB between males and females in this study. After 12 weeks, people taking Gemtesa had less OAB symptoms compared to people taking a placebo.

More recently, a clinical study (COURAGE trial) of Gemtesa included 1,105 men with overactive bladder symptoms receiving treatment for benign prostatic hyperplasia. Compared to placebo, patients taking Gemtesa saw a significant improvement in OAB symptoms. Gemtesa is not currently FDA approved for this use.

References

Gemtesa [package insert]. Revised Feb 2024. Sumitomo Pharma America, Inc. Accessed 05/31/2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=25f21d25-14f8-4fda-91f6-7aa8b68aa1c8

Staskin, D., et. al. (2024). Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial. In: The Journal of Urology. Accessed 05/31/2024 at https://pubmed.ncbi.nlm.nih.gov/38708869/

United States Food and Drug Administration. (2021). Drug Trials Snapshot: GEMTESA. Accessed 05/31/2024 at https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-gemtesa

Read next

Cognitive decline, which may include dementia, memory loss and confusion, is not a known side effect for Gemtesa (vibegron) or the beta-3 agonist class as a whole. In addition, a study found the use of anticholinergic medications among patients with overactive bladder (OAB) was associated with an increased risk of new-onset dementia compared to beta-3 agonist users. Continue reading

Gemtesa (vibegron) starts working almost immediately – within a few days of first taking it, with noticeable improvements in urinary urgency, frequency, and incontinence noted in clinical trials at 2 weeks which were reported as significant by 12 weeks.

After 12 weeks, people taking Gemtesa had 2 fewer daily leakage episodes compared to 1 fewer episode in those taking placebo, 2 fewer bathroom visits (versus 1 fewer with placebo), and 3 fewer “urge to go” visits a day compared to 2 fewer with placebo. Continue reading

No, it isn’t common for Gemtesa (vibegron) to cause high blood pressure. In the phase 3 EMPOWUR trial of patients taking 75 mg of Gemtesa per day, Gemtesa had low rates of high blood pressure (1.7%) that were similar to placebo. Continue reading

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