A Multicenter Maintenance Study of Oral Pilocarpine Tablets for Radiation-Induced Xerostomia

Two hundred sixty-five patients with head and neck cancer who had previously participated in either a fixed-dose, dose-titration, or dose-ranging trial of oral pilocarpine hydrochloride tablets were enrolled in a 36-month

ABSTRACT: Two hundred sixty-five patients with headand neck cancer who had previously participated in either a fixed-dose,dose-titration, or dose-ranging trial of oral pilocarpine hydrochloridetablets were enrolled in a 36-month multicenter maintenance studyto evaluate the long-term safety and efficacy of oral pilocarpinefor the treatment of radiation-induced xerostomia. In this open-labelstudy, the initial drug dose was 5.0 mg tid, with possible adjustmentsfrom 2.5 to 10.0 mg tid or bid. Efficacy was evaluated by subjectivemeasures of oral function. Safety evaluations were based on self-reportof symptoms (or of adverse effects), various examinations, andlaboratory tests. There was significant improvement in all criteriaof oral function. Sweating was the most frequent adverse experience(55%). Less frequent side effects, mild to moderate in nature,included increased urinary frequency, lacrimation, and rhinitis.Side effects usually diminished within hours after the cessationof therapy. We conclude that oral pilocarpine at these doses effectivelyand safely reduces the symptoms of radiation-induced xerostomia.[ONCOLOGY 10{Suppl):16-20, 1996]

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