| Reference | 1. Arch Intern Med. 2002 Jun 10;162(11):1293-300.
<br>
Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome: a
randomized trial.
<br>
Fife RS(1), Chase WF, Dore RK, Wiesenhutter CW, Lockhart PB, Tindall E, Suen JY.
<br>
Author information: <br>
(1)Department of Medicine, Indiana University School of Medicine, 535 Barnhill
Dr, Room 150, Indianapolis, IN 46202, USA.
<br>
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.
<br>
2. Arthritis Rheum. 2002 Mar;46(3):748-54.
<br>
A double-blind, randomized, placebo-controlled study of cevimeline in Sjögren/’s
syndrome patients with xerostomia and keratoconjunctivitis sicca.
<br>
Petrone D(1), Condemi JJ, Fife R, Gluck O, Cohen S, Dalgin P.
<br>
Author information: <br>
(1)Baylor University Medical Center and Arthritis Centers of Texas, Dallas 75246,
USA. [email protected]
<br>
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.<br>
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.<br>
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.
CONCLUSION: 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.
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