Successful Treatment of Dry Mouth and Dry Eye Symptoms in Sjögren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study.
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.
Papas
Athena S
AS
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.
Sherrer
Yvonne S
YS
Charney
Michael
M
Golden
Harvey E
HE
Medsger
Thomas A
TA
Walsh
Bridget T
BT
Trivedi
Madhu
M
Goldlust
Barry
B
Gallagher
Susan C
SC