Pilocarpine tablets for the treatment of dry mouth and dry eye symptoms inpatients with Sjogren syndrome - A randomized, placebo-controlled, fixed-dose, multicenter trial

Background: Patients with Sjogren syndrome (SS) experience slowly progressi ve infiltration of lacrimal and salivary glands by mononuclear cells. This leads to diminished secretions, with resultant symptoms of xerostomia and x erophthalmia. Although pilocarpine hydrochloride tablets are currently indi cated for the treatment of radiation-induced xerostomia, their effects on d ry mouth or dry eyes in patients with SS are unclear. Objective: To assess the safety and efficacy of pilocarpine (Salagen) table ts as symptomatic treatment for dry mouth and dry eyes caused by SS in a mu lticenter, double-blind, placebo-controlled trial. Methods: After providing written informed consent, 373 patients with primar y or secondary SS and clinically significant dry mouth and dry eyes were ra ndomized to receive 2.5-mg pilocarpine, 5-mg pilocarpine, or placebo tablet s 4 times daily for 12 weeks. Symptoms were assessed by questionnaires with visual analog scales or categorical checkboxes. Whole-mouth salivary flow rates were measured. Results: A significantly greater proportion of patients in the 5-mg pilocar pine group showed improvement compared with the placebo group (P less than or equal to.01) in global assessments of dry mouth, dry eyes, and other sym ptoms of dryness (P less than or equal to.05). Salivary flow was significan tly increased 2- to 3-fold (P<.001) after administration of the first dose and was maintained throughout the 12-week study. The most common adverse ef fect was sweating, and no serious drug-related adverse experiences were rep orted. Conclusion: Administration of 5-mg pilocarpine tablets 4 times daily (20 mg /d) was well tolerated and produced significant improvement in symptoms of dry mouth and dry eyes and other xeroses in patients with SS.