In patients receiving long-term administration of pilocarpine hydrochloride for the treatment of xerostomia associated with Sjögren’s syndrome, changes in the volume of salivary secretion, subjective symptom score, and incidence of adverse drug reactions were investigated. The subjects were 64 patients who received pilocarpine hydrochloride for 104 weeks or longer. We assessed changes in the volume of salivary secretion, subjective symptom score, incidence of adverse drug reactions, etc. during the treatment. The assessment revealed that the mean volume of salivary secretion significantly increased after 12 weeks of treatment, compared with that before the treatment. Then, the volume remained unchanged until week 104 of treatment. The mean subjective symptom score significantly decreased after 12 weeks of the treatment. Then, the mean score remained unchanged until week 104 of the treatment. In most patients, adverse drug reactions occurred soon after the treatment initiation, and there were a few patients who subsequently developed new adverse drug reactions. Moreover, hyperhidrosis and pollakisuria persisted for a long period in many patients. These findings suggested that pilocarpine hydrochloride remains effective for enhancing salivary secretion and relieving subjecting symptoms for at least 104 weeks after the treatment initiation. Additionally, long-term administration of the drug did not raise the incidence of adverse drug reactions.
