Safety of Pilocarpine Therapy in Patients With Sjögren’s Syndrome: A Single-Arm Interventional, Post-Market Surveillance Study

Abstract

Sjögren's syndrome is a systemic immune disease with impaired secretion of salivary glands; thus, it may cause inconvenience in patients' daily lives. Pilocarpine is a non-selective muscarinic receptor agonist used to treat dry mouth. This single-arm intervention, post-market surveillance study evaluated the safety of pilocarpine (Salicret, Meider Pharmaceutical Co., Ltd.) for treating Sjögren's syndrome. We recruited 135 patients with Sjögren's syndrome who received pilocarpine orally four times daily at a dose of 5 mg for 24 weeks. Forty-one (31.3%) of 131 patients experienced at least one adverse event (AE), and of those, 37 patients' (28.2%) AEs were associated with the study treatment. The most common drug-related AEs were sweating in 14 patients (10.7%) and palpitation in 9 (6.9%). No serious AEs occurred during the study period. Therefore, pilocarpine therapy is considered effective, safe, and well tolerated in patients with Sjögren's syndrome.