 |
|
Cevimeline for the Treatment of Xerostomia in Patients With Sjögren Syndrome
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.
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
Oral Manifestations of Sjogren's Syndrome
Mathews et al.
J. Dent. Res. 2008;87:308-318.
ABSTRACT
| FULL TEXT
Dry Mouth and Its Effects on the Oral Health of Elderly People
Turner and Ship
Journal of the American Dental Association 2007;138:15S-20S.
ABSTRACT
| FULL TEXT
Lamivudine is not effective in primary Sjogren's syndrome
Gescuk et al.
Ann Rheum Dis 2005;64:1326-1330.
ABSTRACT
| FULL TEXT
Primary Sjogren's syndrome: new clinical and therapeutic concepts
Ramos-Casals et al.
Ann Rheum Dis 2005;64:347-354.
ABSTRACT
| FULL TEXT
Clinical Manifestations and Early Diagnosis of Sjogren Syndrome
Kassan and Moutsopoulos
Arch Intern Med 2004;164:1275-1284.
ABSTRACT
| FULL TEXT
|
