title: Successful Treatment of Dry Mouth and Dry Eye Symptoms in Sjögren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study.
abstract: 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 (P</= 0.0001) after the first dose and throughout the study. Significant improvement in patients' global assessment of dry mouth (P</= 0.0001) with relief in 5 of 7 separate oral symptoms (P</= 0.02) was reported by the treated patients throughout study. Minimal differences in 3 of 8 ocular symptoms were noted at 6 weeks (5-mg dose), but at 12 weeks (5- to 7.5-mg dose), the pilocarpine group demonstrated both significant improvement in global assessment of dry eyes (P</= 0.0001) and relief in 6 of 8 related symptoms (P</= 0.04). The drug was well tolerated at both doses. The most common pilocarpine-related side effects were sweating, urinary frequency, flushing, and chills.
  
  
  CONCLUSIONS
  : 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.
authors.affiliation: 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.
authors.forename: Athena S
authors.initials: AS
authors.lastname: Papas
authors.forename: Yvonne S
authors.initials: YS
authors.lastname: Sherrer
authors.forename: Michael
authors.initials: M
authors.lastname: Charney
authors.forename: Harvey E
authors.initials: HE
authors.lastname: Golden
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Medsger
authors.forename: Bridget T
authors.initials: BT
authors.lastname: Walsh
authors.forename: Madhu
authors.initials: M
authors.lastname: Trivedi
authors.forename: Barry
authors.initials: B
authors.lastname: Goldlust
authors.forename: Susan C
authors.initials: SC
authors.lastname: Gallagher