Abstract | PURPOSE: METHODS AND MATERIALS: Subjects were randomly assigned to receive cevimeline, 30 mg three times daily, or placebo for 12 weeks, with the possibility of dose escalation to 45 mg three times daily at 6 weeks. The primary efficacy endpoint was the patient's final global evaluation of oral dryness; change in unstimulated salivary flow was a secondary endpoint. RESULTS: Five hundred seventy subjects (284 in Study 003 and 286 in Study 004) were randomized. Significantly more cevimeline-treated subjects than placebo recipients (47.4% vs. 33.3%, p = 0.0162) in Study 003 reported improvement in dry mouth in the final global evaluation of oral dryness. No significant difference between groups in the final global evaluation was seen in Study 004, in which a high placebo response rate of 47.6% was observed. In both studies, cevimeline-treated subjects had significantly greater increases in the objective measure of unstimulated salivary flow than placebo recipients (p = 0.0093 [Study 003] and p = 0.0215 [Study 004]), whereas no significant differences in stimulated salivary flow were observed. The most frequent adverse event was increased sweating. CONCLUSION:
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Authors | Mark S Chambers, Marshall Posner, Christopher Uwe Jones, Merrill A Biel, Kenneth M Hodge, Robert Vitti, Ingrid Armstrong, Cindy Yen, Randal S Weber |
Journal | International journal of radiation oncology, biology, physics
(Int J Radiat Oncol Biol Phys)
Vol. 68
Issue 4
Pg. 1102-9
(Jul 15 2007)
ISSN: 0360-3016 [Print] United States |
PMID | 17379432
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Muscarinic Antagonists
- Quinuclidines
- Thiophenes
- cevimeline
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Topics |
- Double-Blind Method
- Female
- Head and Neck Neoplasms
(radiotherapy)
- Humans
- Male
- Middle Aged
- Muscarinic Antagonists
(therapeutic use)
- Quinuclidines
(adverse effects, therapeutic use)
- Salivation
(drug effects, physiology)
- Thiophenes
(adverse effects, therapeutic use)
- Xerostomia
(drug therapy, etiology)
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