Abstract
A total of 137 patients with Sjögren syndrome (Sjs) and dry mouth were enrolled in a trial of Cevimeline hydrochloride (Evoxac®) for 18 months. They included 19 patients with primary Sjs, 12 with secondary Sjs, 80 with possible Sjs and 25 non-Sjs patients. The age of the patients was 61.4±13.5 years. Sjs was diagnosed according to the criteria proposed by the Japanese Medical Society for Sjs under the auspices of the Japanese Ministry of Health and Welfare (1999). The patients initially received 3 capsules of Evoxac® (90mg) daily, but the dose was reduced by half to a minimum of 1/6 of a capsule) in the event of gastrointestinal symptoms such as gastric discomfort, nausea, and vomiting. The speed of improvement of subjective symptoms was classified into four categories (marked, moderately, slightly improved, and no improvement), which accounted for 28, 37, 58 and 14 patients, respectively. In 55 patients, there was an increase in salivation, and salivation increased during sleep in 15 patients. Many of the patients in whom excellent efficacy was observed had possible Sjs or non-Sjs, while only a few had typical Sjs. Nocturnal sweating, dry mouth, heartburn, and flatulence were seen as accompanying symptoms, while gastric discomfort (10 cases), nausea and vomiting (7 cases) and abdominal pain and diarrhea (4 cases) were recognized as side effects. This medicine was useful for patients with dry mouth, although transient side effects sometimes occurred.