Safety of Pilocarpine Therapy in Patients With Sjögren’s Syndrome: A Single-Arm Interventional, Post-Market Surveillance Study
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2019, Vol 13, Issue 4
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.The functions of saliva include lubricating the mouth, aiding in the digestion process, and possessing antimicrobial functions [1]. Xerostomia is dryness of the mouth that may be associated with a change in the composition of saliva or reduced salivary flow [2]. Dehydration, malfunction of the salivary glands, or radiotherapy of the area of the salivary glands can cause xerostomia. The general symptoms of xerostomia include a persistent oral burning sensation, eating difficulties, diminution in taste acuity, discomfort speaking, recurrent mucosal infections, greater periodontal disease, and denture intolerance [3]. Xerostomia affects the mechanical process of providing moisture and lubricating the mouth with saliva, and the chemical, antimicrobial, remineralizing, and buffering functions of saliva [4]. A reduction in salivation is paralleled by a shift to highly cariogenic microflora at the expense of non-cariogenic organisms [5]. Therefore, saliva plays important roles in protecting the oral cavity. Sjögren’s syndrome is one of the causes of xerostomia with destructive salivary and lacrimal glands due to abnormal infiltration of lymphocytes [6]. The attack on these exocrine glands may lead to the development of xerostomia and keratoconjunctivitis sicca.The autoimmune response to Sjögren’s syndrome is associated with lymphocytic infiltration that eventually causes severe damage or destruction of the glands. Clinically, there are two classes of Sjögren’s syndrome: primary and secondary types. Primary Sjögren’s syndrome occurs independently, whereas secondary Sjögren’s syndrome occurs concomitantly with other connective tissue diseases [7]. Primary Sjögren’s syndrome is a common systemic autoimmune disease with a prevalence of 0.05-4.8% [8]. Its incidence in women is approximately 9 times higher than that in men [9]. Secondary Sjögren’s syndrome may be associated with rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, multiple sclerosis, autoimmune thyroiditis, and autoimmune hepatitis [10]. Patients with primary or secondary Sjögren’s syndrome have the same level of discomfort, complications, and severity of disease. Oral lesions including angular cheilitis, atrophic glossitis, recurrent ulcerations, and fissurations of the tongue are usually found [11]. The pathogenesis of Sjögren’s syndrome is unknown, but it is believed to be caused by genetic predisposition, environmental and hormonal factors, and a disordered immune system [6,12].
Authors and Affiliations
Deng-Ho Yang, Feng-Cheng Liu, Chun-Chi Lu, San-Yuan Kuo, Shi-Jye Chu, Hsiang-Cheng Chen
Keywords
Related Articles
- EP ID EP598325
- DOI 10.26717/BJSTR.2019.13.002444
- Views 141
- Downloads 0
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