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


CONCLUSIONS
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.
Petrone
Dianne
D
Baylor University Medical Center and Arthritis Centers of Texas, Dallas 75246, USA. trone6534@aol.com
Condemi
John J
JJ
Fife
Rose
R
Gluck
Oscar
O
Cohen
Stanley
S
Dalgin
Paul
P
D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007638:Keratoconjunctivitis Sicca / Q000150:complications* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018721:Muscarinic Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011812:Quinuclidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D012463:Saliva / Q000502:physiology; D012859:Sjogren's Syndrome / Q000150:complications* / Q000188:drug therapy*; D013666:Tears / Q000502:physiology; D013876:Thiophenes; D014987:Xerostomia / Q000150:complications* / Q000503:physiopathology
D018721:Muscarinic Agonists; D010919:Placebos; D011812:Quinuclidines; D013876:Thiophenes; C059240:cevimeline