Xerostomia, or dry mouth, is a significant challenge for patients with Sjögren’s syndrome, often resulting in discomfort, difficulty in speaking and swallowing, and a reduced quality of life. A recent systematic review and meta-analysis, published in Current Therapeutic Research, provided new insights into the effectiveness of cevimeline in treating xerostomia in Sjögren’s syndrome.
The study systematically reviewed randomized clinical trials (RCTs) to assess the impact of cevimeline on salivary secretion and mouth dryness. The meta-analysis included three RCTs involving 302 patients, with 187 receiving cevimeline and 115 assigned to placebo groups. Statistical evaluation revealed a significant improvement in xerostomia symptoms among patients treated with cevimeline. The pooled odds ratio of -5.79 (95% CI [-10.55, -1.03]) highlighted a substantial reduction in dryness and an increase in salivary flow. The heterogeneity index (I² = 39.6%) suggested moderate variability across the included studies, reinforcing the reliability of the findings.
Cevimeline hydrochloride is a cholinergic agent with potent muscarinic agonist activity, primarily targeting M1 and M3 receptors found abundantly in exocrine glands. Its chemical structure is defined as 2-methylspiro[1,3-oxathiolane-5,3′-1-azabicyclo[2.2.2]octane]. In scientific literature and clinical research, it appears under various designations including AF102B, FKS-508, SNK-508, SND-5008, and SNI-201. The FDA has approved its oral formulation under the brand name Evoxac® for “treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.” When administered in therapeutic doses, cevimeline enhances secretion from exocrine glands (particularly salivary and sweat glands) and increases smooth muscle tone throughout the gastrointestinal and urinary tracts.
Beyond its role in managing xerostomia, cevimeline has demonstrated potential neuroprotective effects. Studies indicate that cevimeline improved experimentally induced cognitive deficits in animal models. Additionally, it has been shown to positively influence tau pathology and reduce amyloid-β (Aβ) peptide levels in the cerebrospinal fluid of patients with Alzheimer’s disease.
The findings of the current meta-analysis underscore cevimeline’s potential as a viable treatment for xerostomia in Sjögren’s syndrome, particularly in patients with mild to moderate salivary gland dysfunction. With a favorable safety profile at recommended dosages, cevimeline offers a promising approach to improving salivary flow and alleviating dry mouth discomfort. While these results highlight its clinical benefits, further large-scale RCTs are needed to refine dosing strategies and evaluate long-term outcomes. Nonetheless, this study reinforces cevimeline’s therapeutic value for patients with Sjögren’s syndrome.
References
- Karimi M, Hajikolaei FA, Hoseinpour F, Hashemi SA, Fatehi A, Pakmehr SA, et al. Efficacy of Cevimeline on Xerostomia in Sjögren’s Syndrome Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Curr Ther Res Clin Exp. 2024 Dec 12;102:100770.
- Oleksak P, Novotny M, Patocka J, Nepovimova E, Hort J, Pavlik J, et al. Neuropharmacology of Cevimeline and Muscarinic Drugs-Focus on Cognition and Neurodegeneration. Int J Mol Sci. 2021 Aug 18;22(16):8908.
- Fife RS, Chase WF, Dore RK, Wiesenhutter CW, Lockhart PB, Tindall E, et al. Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome: a randomized trial. Arch Intern Med. 2002 Jun 10;162(11):1293-300.