Can Gemtesa cause dementia?
Cognitive decline, which may include dementia, memory loss and confusion, is not a known side effect for Gemtesa (vibegron)
Gemtesa is a prescription medicine used to treat overactive bladder symptoms, such as urinary urge incontinence (leakage), urgency, and frequency. It is classified as a selective beta-3 agonist and it helps the bladder to relax so it can hold more urine.
Cognitive decline or dementia is not a known side effect for 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.
Gemtesa does not cross into the brain and does not have anticholinergic properties like some older medicines used to treat overactive bladder (OAB). This property may increase its safety, especially among older adults or patients in long-term care (LTC) settings needing OAB treatment.
Which medicines used for OAB can cause dementia?
Anticholinergic / antimuscarinic agents used for OAB, such as oxybutynin (Ditropan XL) or tolterodine (Detrol LA) work by blocking the release of acetylcholine and directly relaxes the bladder muscles. But anticholinergic side effects can include agitation, confusion, dizziness, drowsiness, blurred vision, hallucinations, memory impairment or increased risk of falls or broken bones.
In addition, several studies have shown a consistent association between use of anticholinergic medications for OAB such as oxybutynin or tolterodine and an increased risk of dementia. Overactive bladder medications are typically used over the long-term, further compounding this risk.
Many other drugs have anticholinergic properties and can lead to central nervous system side effects. These medicines are not preferred medications for older patients. For example, tricyclic antidepressants (such as amitriptyline) and first generation antihistamines (such as diphenhydramine, also called Benadryl) have a high burden of anticholinergic effect and have also been associated with memory loss, dementia and Alzheimer’s disease.
Learn More: Anticholinergic Drugs to Avoid in the Elderly
Is Gemtesa safe in older patients?
According to the manufacturer, no differences in safety or effectiveness of Gemtesa have been seen between patients 65 years of age and older and younger adult patients.
In studies, most patients tolerated Gemtesa well. Less than 2 out of every 100 patients stopped treatment due to side effects.
The most common side effects with Gemtesa (vibegron) and reported in at least 2 out of every 100 patients in clinical studies after 12 or 52 weeks were:
- Headache (4%)
- Common cold symptoms, like nasal congestion, sore throat or runny nose (2.8%)
- Diarrhea (2.2%)
- Nausea (2.2%)
- Upper respiratory tract infections (2%)
- Urinary tract infection (6.6%)
- Bronchitis (2.9%)
Gemtesa may also increase your chances of not being able to empty your bladder. Discuss this warning with your doctor, as you may need to stop treatment if it develops.
This is not all the information you need to know about Gemtesa (vibegron) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.
- Gray SL, Anderson ML, Dublin S, et al. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015;175(3):401-407. doi:10.1001/jamainternmed.2014.7663
- Coupland CAC, Hill T, Dening T, et al. Anticholinergenic drug exposure and the risk of dementia: a nested case-control study. JAMA Intern Med. Published online June 24, 2019. doi:10.1001/ jamainternalmed.2019.0677.
- Welk B, McArthur E. Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU Int. 2020;126(1):183-190. doi:10.1111/bju.15040
- Rechberger T, Wróbel A. Evaluating vibegron for the treatment of overactive bladder. Expert Opin Pharmacother. 2021 Jan;22(1):9-17. doi: 10.1080/14656566.2020.1809652. Epub 2020 Sep 29. PMID: 32993398.
- Frankel J, Staskin D, Varano S, Kennelly MJ, Jankowich RA, Haag-Molkenteller C. An Evaluation of the Efficacy and Safety of Vibegron in the Treatment of Overactive Bladder. Ther Clin Risk Manag. 2022;18:171-182. Published 2022 Mar 3. doi:10.2147/TCRM.S310371
- Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and Safety of Once-Daily Vibegron for Treatment of Overactive Bladder in Patients Aged ≥65 and ≥75 Years: Subpopulation Analysis from the EMPOWUR Randomized, International, Phase III Study. Drugs Aging. 2021;38(2):137-146. doi:10.1007/s40266-020-00829-z
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