Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome

A randomized trial

Rose Fife, Walter F. Chase, Robin K. Dore, Craig W. Wiesenhutter, Peter B. Lockhart, Elizabeth Tindall, James Y. Suen

Research output: Contribution to journalArticle

124 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1293-1300
Number of pages8
JournalArchives of Internal Medicine
Volume162
Issue number11
StatePublished - Jun 10 2002

Fingerprint

Xerostomia
Muscarinic Agonists
Placebos
Therapeutics
Artificial Saliva
Exocrine Glands
cevimeline
Salivary Glands
Drug-Related Side Effects and Adverse Reactions
Visual Analog Scale
Nausea
Cholinergic Agents
Mouth
Gastrointestinal Tract
Outpatients
Randomized Controlled Trials
Safety

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Fife, R., Chase, W. F., Dore, R. K., Wiesenhutter, C. W., Lockhart, P. B., Tindall, E., & Suen, J. Y. (2002). Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome: A randomized trial. Archives of Internal Medicine, 162(11), 1293-1300.

Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome : A randomized trial. / Fife, Rose; Chase, Walter F.; Dore, Robin K.; Wiesenhutter, Craig W.; Lockhart, Peter B.; Tindall, Elizabeth; Suen, James Y.

In: Archives of Internal Medicine, Vol. 162, No. 11, 10.06.2002, p. 1293-1300.

Research output: Contribution to journalArticle

Fife, R, Chase, WF, Dore, RK, Wiesenhutter, CW, Lockhart, PB, Tindall, E & Suen, JY 2002, 'Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome: A randomized trial', Archives of Internal Medicine, vol. 162, no. 11, pp. 1293-1300.
Fife R, Chase WF, Dore RK, Wiesenhutter CW, Lockhart PB, Tindall E et al. Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome: A randomized trial. Archives of Internal Medicine. 2002 Jun 10;162(11):1293-1300.
Fife, Rose ; Chase, Walter F. ; Dore, Robin K. ; Wiesenhutter, Craig W. ; Lockhart, Peter B. ; Tindall, Elizabeth ; Suen, James Y. / Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome : A randomized trial. In: Archives of Internal Medicine. 2002 ; Vol. 162, No. 11. pp. 1293-1300.
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