• Athena S Papas, Yvonne S Sherrer, Michael Charney, Harvey E Golden, Thomas A Medsger, Bridget T Walsh, Madhu Trivedi, Barry Goldlust, and Susan C Gallagher.
• From the *Tufts University Dental School, Boston, MA; †Center for Rheumatology, Immunology, and Arthritis, Ft. Lauderdale, FL; ‡Denver Arthritis Clinic, Denver, CO; §Rush Medical College, Evanston, IL; ¶Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA; ∥South Arizona VA Healthcare Systems, Tucson, AZ; **Om Compu-Stat Consulting, Rochester, NY; ††Santarus, Inc., San Diego, CA; and ‡‡MGI PHARMA, Inc., Bloomington, MN.
• J Clin Rheumatol. 2004 Aug 1;10(4):169-77.

Background: Sjögren's syndrome is characterized by the presence of xerostomia and/or xerophthalmia. Pilocarpine, a muscarinic cholinergic agonist, has been proven to be efficacious in treating radiation-induced xerostomia (up to 30 mg/day) and symptoms of dry mouth in Sjögren's patients (up to 20 mg/day).Objective: To compare the safety and efficacy of oral pilocarpine (dose-adjusted) versus placebo in the treatment of dry eye and dry mouth symptoms in Sjögren's syndrome at 6 and 12 weeks.Methods: In this 11-center, 256-patient placebo-controlled study, the safety and efficacy of oral pilocarpine (20 mg to 30 mg daily) for relief of Sjögren's-related dry mouth and dry eye symptoms was assessed. Changes in symptoms and salivary flow were measured over 12 weeks.Results: Compared with placebo, salivary flow was significantly increased in the pilocarpine group (PConclusions: Significant relief in dry mouth symptoms was noted at 20 mg/day, and significant relief in ocular symptoms, including lower artificial tear requirement, was noted after the dose was increased to 30 mg/day.

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