Cevimeline hydrochloride hydrate is an agent with muscarinic agonist activity that is used to treat xerostomia in patients with Sjögren's syndrome (SS). We evaluated the efficacy and safety of cevimeline hydrochloride hydrate for the treatment of xerostomia in 54 patients with SS who received the drug for 3 to 21 months.
Salivary flow rate, objective findings, and subjective symptoms such as “xerostomia”, “decreased saliva”, “increased fluid intake”, and “difficulty in swallowing” were significantly improved by 6 months. Salivary flow rate increased in patients who had mild destruction of salivary glands as assessed by sialography and lip biopsies. Symptoms improved in both patients with mild and severe destruction of salivary glands.
Six patients discontinued treatment within 1 month because of nausea and/or vomiting (3 patients), eruption (2 patients), and pregnancy (1 patient). Sweating, heartburn, swelling of parotid glands, diarrhea, headache, nausea and/or vomiting, constipation, and eruption occurred as side effects in 35.0%, 35.0%, 13.3%, 8.3%, 6.7%, 6.7%, 5.0%, and 3.3% of the patients, respectively. Although sweat persisted, other side effects were controlled by symptomatic treatment or decreasing the dose.
These results showed that cevimeline hydrochloride hydrate is effective for improving the quality of life of patients with SS who have dry mouth.
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