Therapeutic effect of cevimeline on dry eye in patients with Sjögren's syndrome

A randomized, double-blind clinical study

Masasfumi Ono, Etsuko Takamura, Kazumi Shinozaki, Tomoko Tsumura, Takashi Hamano, Yukiko Yagi, Kazuo Tsubota

Research output: Contribution to journalArticle

77 Citations (Scopus)

Abstract

Purpose Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by salivary and lacrimal glandular destruction leading to symptoms of dry mouth and dry eye. Dryness can also occur in the absence of glandular destruction. Patients with SS have autoantibodies that bind to muscarinic acetylcholine receptors in the exocrine glands. Recently, a muscarinic acetylcholine receptor agonist, cevimeline, has been approved for use against symptoms of dry mouth in patients with SS. In this study, the efficacy of cevimeline in improving symptoms of dry eye was examined. Design Prospective, randomized, double-blind, multi-center clinical study. Methods Sixty patients were randomly assigned to three groups - placebo; cevimeline, 20 mg three times daily; or cevimeline, 30 mg three times daily - and received treatment for 4 weeks. Patients were evaluated before treatment, at week 2, at the end of treatment, and at the end of a 2- to 4-week follow-up period. Results Compared with the placebo, statistically significant differences were seen with cevimeline, 20 mg three times daily, in subjective symptoms, tear dynamics, condition of the corneoconjunctival epithelium, and global improvement rating. No difference was found among the three groups regarding the safe use of the drug. Conclusions These results indicate that cevimeline, 20 mg three times daily, is safe and effective in improving symptoms of dry eye in patients with SS. Additional studies, with larger patient populations, are needed to further assess the effectiveness of cevimeline for dry eye.

Original languageEnglish
Pages (from-to)6-17
Number of pages12
JournalAmerican Journal of Ophthalmology
Volume138
Issue number1
DOIs
Publication statusPublished - 2004 Jul
Externally publishedYes

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Therapeutic Uses
Double-Blind Method
Muscarinic Receptors
Tears
Mouth
Placebos
Exocrine Glands
Cholinergic Agonists
cevimeline
Clinical Studies
Autoantibodies
Autoimmune Diseases
Therapeutics
Epithelium
Pharmaceutical Preparations
Population

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Therapeutic effect of cevimeline on dry eye in patients with Sjögren's syndrome : A randomized, double-blind clinical study. / Ono, Masasfumi; Takamura, Etsuko; Shinozaki, Kazumi; Tsumura, Tomoko; Hamano, Takashi; Yagi, Yukiko; Tsubota, Kazuo.

In: American Journal of Ophthalmology, Vol. 138, No. 1, 07.2004, p. 6-17.

Research output: Contribution to journalArticle

Ono, Masasfumi ; Takamura, Etsuko ; Shinozaki, Kazumi ; Tsumura, Tomoko ; Hamano, Takashi ; Yagi, Yukiko ; Tsubota, Kazuo. / Therapeutic effect of cevimeline on dry eye in patients with Sjögren's syndrome : A randomized, double-blind clinical study. In: American Journal of Ophthalmology. 2004 ; Vol. 138, No. 1. pp. 6-17.
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