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A Randomized Trial

Rose S. Fife, MD; Walter F. Chase, MD; Robin K. Dore, MD; Craig W. Wiesenhutter, MD; Peter B. Lockhart, DDS; Elizabeth Tindall, MD; James Y. Suen, MD

Arch Intern Med. 2002;162:1293-1300.

Background  Cevimeline hydrochloride is a cholinergic agent with muscarinic agonist activity prominently affecting the M1 and M3 receptors prevalent in exocrine glands. We evaluated the safety and efficacy of cevimeline in the treatment of xerostomia in patients with Sjögren syndrome.

Methods  Seventy-five patients with Sjögren syndrome and associated salivary gland dysfunction were enrolled in a double-blind, randomized, placebo-controlled trial at 8 university- and office-based outpatient clinical facilities in the United States. Eligible study participants were randomized to receive 30 mg of cevimeline 3 times daily, 60 mg of cevimeline 3 times daily, or placebo for 6 weeks. Subjective responses were determined using global patient evaluation and visual analog scales. Salivary flow was measured objectively.

Results  Sixty-one participants completed the study. Patients in both cevimeline groups had significant improvements in dry mouth, as indicated by symptoms, salivary flow, and use of artificial saliva, compared with the placebo group. The drug was generally well tolerated, with expected adverse events resulting from the drug's muscarinic agonist action. Fourteen patients withdrew from the study because of adverse events, the most frequent being nausea.

Conclusions  Therapy with cevimeline, 30 mg 3 times daily, seems to be well tolerated and to provide substantive relief of xerostomia symptoms. Although both dosages of cevimeline provided symptomatic improvement, 60 mg 3 times daily was associated with an increase in the occurrence of adverse events, particularly gastrointestinal tract disorders. Use of 30 mg of cevimeline provides a new option for the treatment of xerostomia in Sjögren syndrome.

From the Department of Medicine, Indiana University School of Medicine, Indianapolis (Dr Fife); the Division of Rheumatology, University of California, Los Angeles, School of Medicine (Dr Dore); the Coeur d'Alene Arthritis Clinic, Coeur d'Alene, Idaho (Dr Wiesenhutter); the Department of Oral Medicine, Carolinas Medical Center, Charlotte, NC (Dr Lockhart); the Department of Medicine, Oregon Health Sciences University, Portland (Dr Tindall); and the Department of Otolaryngology–Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock (Dr Suen). Dr Chase is in private practice in Austin, Tex.

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