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A Randomized, Placebo-Controlled, Fixed-Dose, Multicenter Trial

Frederick B. Vivino, MD; Ibtisam Al-Hashimi, PhD; Zafrulla Khan, DDS; Francis G. LeVeque, DDS; Paul L. Salisbury III, DDS; Tram K. Tran-Johnson, PharmD, PsyD; Charles C. Muscoplat, PhD; Madhu Trivedi, PhD; Barry Goldlust, PhD; Susan C. Gallagher, MS; for the P92-01 Study Group

Arch Intern Med. 1999;159:174-181.

Background  Patients with Sjögren syndrome (SS) experience slowly progressive infiltration of lacrimal and salivary glands by mononuclear cells. This leads to diminished secretions, with resultant symptoms of xerostomia and xerophthalmia. Although pilocarpine hydrochloride tablets are currently indicated for the treatment of radiation-induced xerostomia, their effects on dry mouth or dry eyes in patients with SS are unclear.

Objective  To assess the safety and efficacy of pilocarpine (Salagen) tablets as symptomatic treatment for dry mouth and dry eyes caused by SS in a multicenter, double-blind, placebo-controlled trial.

Methods  After providing written informed consent, 373 patients with primary or secondary SS and clinically significant dry mouth and dry eyes were randomized to receive 2.5-mg pilocarpine, 5-mg pilocarpine, or placebo tablets 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 pilocarpine group showed improvement compared with the placebo group (P.01) in global assessments of dry mouth, dry eyes, and other symptoms of dryness (P.05). Salivary flow was significantly 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 effect was sweating, and no serious drug-related adverse experiences were reported.

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.

The affiliations of the authors and the names of the members of the P92-01 Study Group appear in the acknowledgment section at the end of article.

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