Evoxac eases dry mouth symptoms in Sjögren’s patients, review finds
Clinical trials seen to support therapy, particularly with milder disease activity
Treatment with Evoxac (cevimeline hydrochloride) significantly improved salivary flow and eased symptoms of dry mouth in people with Sjögren’s syndrome, according to a meta-analysis of three clinical trials.
These findings suggest that Evoxac, an approved Sjögren’s treatment, is a “promising therapeutic option, particularly for individuals with mild to moderate salivary gland damage,” the researchers wrote.
The study, “Efficacy of Cevimeline on Xerostomia in Sjögren’s Syndrome Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials,” was published in the journal Current Therapeutic Research.
Evoxac is approved to treat dry mouth due to Sjögren’s syndrome
Dry mouth (xerostomia) is a characteristic symptom of Sjögren’s syndrome that significantly impacts patients’ quality of life. Xerostomia causes difficulty in speaking, eating, and swallowing, and also increases the risk of dental decay and infections. It is caused by the immune-mediated destruction of the salivary glands, which reduces saliva production.
Stimulating saliva production with medications, such as Evoxac, is one of the strategies that can be used to manage xerostomia and improve patients’ well-being. Evoxac is approved to treat dry mouth in people with Sjögren’s, but its efficacy remains debatable due to inconsistent study results, and uncertainties concerning optimal dosage and treatment duration, the study noted.
To address these gaps, a team of researchers in Ukraine and Iran analyzed data from studies published through Jan. 3, 2024. The goal was to evaluate Evoxac’s effectiveness in alleviating xerostomia by analyzing its impact on salivary flow and oral dryness in people with Sjögren’s.
Their review study, they added, appears to be the first “comprehensively assess the impact of [Evoxac] on xerostomia in patients with Sjögren’s syndrome.”
Three randomized clinical trials involving a total of 302 Sjögren’s patients were included in the meta-analysis. Adults in these studies, ages 23 to 86, were randomly assigned to receive a placebo (115 patients) or Evoxac (187 patients). Two trials were conducted in the U.S., with both male and female patients, while the third took place in China with female patients.
Evoxac was administered orally, three times a day, at a dose of 15, 30, or 60 mg. Patients were followed for six to 24 weeks (about six months), depending on the study.
Better response rates seen in people with mild to moderate symptoms
Results showed that Evoxac significantly reduced xerostomia, as measured by improvements in salivary flow and decreased mouth dryness.
“Our findings demonstrate that [Evoxac] significantly improves salivary flow and reduces symptoms of dry mouth, supporting its role as an effective therapeutic option for patients with Sjögren’s syndrome,” the researchers wrote.
However, its efficacy “may vary based on individual factors,” they added. “Treatment with [Evoxac] at a dosage of 30 mg three times daily has been well-tolerated and significantly reduces xerostomia-related symptoms. Notably, increasing the dosage to 60 mg three times a day has been associated with a rise in adverse effects, particularly affecting the digestive system.”
They also noted that “further research involving diverse populations and varying disease severities is crucial to solidify [Evoxac’s] role as a reliable treatment for xerostomia in Sjögren’s syndrome,” particularly as people “with less severe disease activity have shown better response rates” to the treatment.