A Clinical Study on the Prolonged Administration of Pilocarpine Hydrochloride for Paient Suffered from Xerostomia Due to Sjögren's Syndrome: Incidence of Adverse Reaction, Change of Salivary Secretion, and Subjective Symptom Due to the Prolonged Administration

We evaluated the efficacy of pilocarpine hydrochloride and adverse drug reactions (ADRs) associated with administration of pilocarpine hydrochloride. A marketing approval has recently been granted to pilocarpine hydrochloride as a treatment for xerostomia associated with Sjögren's syndrome ("SS"). Among the patients treated with pilocarpine hydrochloride from October 2007 to March 2009, our study included 64 patients who had not previously been treated with cevimeline hydrochloride or anetholetrithione and were able to be followed for 4 weeks post-treatment. Salivary secretion and symptom scores were evaluated in 42 patients followed up for 52 weeks after starting the treatment. The results of salivary secretion (10-minute gum test) were significantly improved from baseline to 24 weeks after the initiation of treatment and thereafter. Subjective symptom scores were significantly improved from baseline to 12 weeks after the initiation of treatment and thereafter. No decrease in efficacy of pilocarpine hydrochloride due to the prolonged administration was observed in any subjects examined. ADRs occurred in 81.3% of patients. The most common ADR was heavy sweating followed by nausea and urinary frequency. Fifteen point six percent of the patient, discontinued the treatment because of adverse drug reactions such as nausea, urinary frequency or others. ADRs occurred within 4 weeks after the initiation of treatment 97.9% of patients. Nausea disappeared in 38.5% of patients by 12 weeks after the initiation of treatment. No increased incidence of ADRs due to the prolonged administration was observed in any subjects examined.