A double‐blind, randomized, placebo‐controlled study of cevimeline in Sjögren's syndrome patients with xerostomia and keratoconjunctivitis sicca

Abstract

Objective. To evaluate the safety and efficacy of 2 dosages of cevimeline for the treatment of xerostomia and keratoconjunctivitis sicca in patients with Sjögren's syndrome.Methods. A 12-week, double-blind, randomized, placebo-controlled study was performed. Patients were randomly assigned to receive either placebo, 15 mg of cevimeline 3 times daily, or 30 mg of cevimeline 3 times daily. Patients were evaluated at baseline and throughout the study for their global assessment of dryness (mouth, eyes, overall) as well as their subjective assessment of the specific symptoms of dry mouth and dry eyes. Total saliva and tear flow also were measured.Results. Patients taking 30 mg of cevimeline 3 times daily had statistically significant improvements in their subjective global assessment of dry eyes (P ‫؍‬ 0.0453), dry mouth (P ‫؍‬ 0.0004), and increased salivary flow (P ‫؍‬ 0.007). Patients receiving the 30-mg dosage also showed greater objective improvement (increased salivary and lacrimal flow rates, as measured by Schirmer's test) than did patients receiving placebo. Frequently reported adverse events included headache, increased sweating, abdominal pain, and nausea. Conclusion.Treatment with cevimeline at a dosage of 30 mg 3 times daily resulted in substantive improvement by increasing the rate of saliva and tear flow in patients with Sjögren's syndrome, as well as improving subjective symptoms of dry mouth, dry eyes, and overall dryness. The 15-mg dosage relieved some symptoms, and both dosages were well tolerated.

Immunoglobulins from scleroderma patients inhibit the muscarinic receptor activation in internal anal sphincter smooth muscle cells

“…There is evidence to suggest that these autoantibodies block cholinergic neurotransmission at the G protein-coupled M 3 -R, based on radioligand binding and functional studies in the colon (6,19). It has been suggested that the second extracellular loop of M 3 -R may be an epitope for the IgGs as reported in the case of Sjögren's syndrome, another systemic autoimmune disorder (31,39). On the basis of these concepts (39), intravenous infusion of IgG (which works via the neutralization of SSc IgGs) has been used in the symptomatic treatment of SSc (6).…”

“…It has been suggested that the second extracellular loop of M 3 -R may be an epitope for the IgGs as reported in the case of Sjögren's syndrome, another systemic autoimmune disorder (31,39). On the basis of these concepts (39), intravenous infusion of IgG (which works via the neutralization of SSc IgGs) has been used in the symptomatic treatment of SSc (6).…”

Diagnosis and treatment of primary Sjogren’s syndrome: an update

“…Muscarinic agents such as pilocarpine and cevimeline have been shown to be effective in randomized control trials conducted in the late 1990s' in terms of improvement of salivary flow upon a period of 12 weeks. [10][11] However, these agents are mostly poorly tolerated due to prominent side effects of sweating, flushing, nausea, diarrhea and chills.…”

Sjögren´s syndrome in present

“…Preparation Salagen tablets are available. Studies were performed with cevimeline hydrochloride hydrate -an agonist of muscarine receptors (4,8). Levamisole and Chinese herbal extracts were used in herpetic ulcerations (10).…”