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 language | English |
|---|---|
| Pages (from-to) | 6-17 |
| Number of pages | 12 |
| Journal | American Journal of Ophthalmology |
| Volume | 138 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2004 Jul |
| Externally published | Yes |
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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 journal › Article
}
TY - JOUR
T1 - Therapeutic effect of cevimeline on dry eye in patients with Sjögren's syndrome
T2 - A randomized, double-blind clinical study
AU - Ono, Masasfumi
AU - Takamura, Etsuko
AU - Shinozaki, Kazumi
AU - Tsumura, Tomoko
AU - Hamano, Takashi
AU - Yagi, Yukiko
AU - Tsubota, Kazuo
PY - 2004/7
Y1 - 2004/7
N2 - 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.
AB - 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.
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U2 - 10.1016/j.ajo.2004.02.010
DO - 10.1016/j.ajo.2004.02.010
M3 - Article
VL - 138
SP - 6
EP - 17
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
IS - 1
ER -