A Study of Ultra-Long-Term Administration of Pilocarpine Hydrochloride in Patients with Xerostomia Due to Sjögren's Syndrome

—An Examination of the Safety and Drug Resistance—

Abstract

We examined the safety and efficacy of super-long-term pilocarpine hydrochloride administration for oral dryness associated with Sjögren's syndrome. Sixty-two patients administered pilocarpine hydrochloride from October 2007 to March 2009 were assessed 2 or more years after the start of administration. Three cases of heavy sweating were observed 2 or more years after drug initiation. These symptoms were mild, and administration was continued. Furthermore, pre-existing adverse drug reactions showed no aggravation. Abnormal biochemical blood test results were observed in 71.0% of patients (n = 68). All changes were slight, and administration was continued in all patients. Even with continuous administration, the patients showed no symptom aggravation. No significant change in salivary secretion or subjective symptom score was observed in 27 patients after 5 years.