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Safety of Pilocarpine Therapy in Patients with Sjögren's Syndrome

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Safety of Pilocarpine Therapy in Patients with Sjögren's Syndrome ISSN: 2574-1241 DOI: 10.26717/BJSTR.2019.13.002444 Hsiang-Cheng Chen. Biomed J Sci & Tech Res Research Article Open Access Safety of Pilocarpine Therapy in Patients With Sjögren’s Syndrome: A Single-Arm Interventional, Post-Market Surveillance Study Deng-Ho Yang1-4, Feng-Cheng Liu4, Chun-Chi Lu4, San-Yuan Kuo4, Shi-Jye Chu4, and Hsiang-Cheng Chen*4 1Division of Rheumatology/Immunology/Allergy, Department of Internal Medicine, Taichung Armed-Forces General Hospital, Taichung, Taiwan 2Department of Laboratory, Taichung Armed Forces General Hospital, Taichung, Taiwan 3Department of Medical Laboratory Science and Biotechnology, Central Taiwan University of Science and Technology, Taichung, Taiwan 4Division of Rheumatology/Immunology/Allergy, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan Received: January 16, 2019; Published: January 28, 2019 *Corresponding author: Hsiang-Cheng Chen, Division of Rheumatology/Immunology/Allergy, Department of Internal Medicine, Tri- Service General Hospital, No. 325, Sec. 2, Cheng-Kung Rd, Neihu 114, Taipei, Taiwan Abstract Sjögren’s syndrome is a systemic immune disease with impaired secretion of salivary glands; thus, it may cause inconvenience in patients’ daily study evaluated the safety of pilocarpine (Salicret, Meider Pharmaceutical Co., Ltd.) for treating Sjögren’s syndrome. We recruited 135 patients with lives. Pilocarpine is a non-selective muscarinic receptor agonist used to treat dry mouth. This single-arm intervention, post-market surveillance 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 wereSjögren’s sweating syndrome in 14 who patients received (10.7%) pilocarpine and palpitation orally four in times9 (6.9%). daily No at seriousa dose of AEs 5 mg occurred for 24 weeks. during Forty-one the study (31.3%)period. Therefore, of 131 patients pilocarpine experienced therapy at is considered effective, safe, and well tolerated in patients with Sjögren’s syndrome. Keywords: Pilocarpine; Salicret; Sjögren’s Syndrome; Adverse Event Introduction The functions of saliva include lubricating the mouth, aiding in The autoimmune response to Sjögren’s syndrome is associated the digestion process, and possessing antimicrobial functions [1]. Xerostomia is dryness of the mouth that may be associated with or destruction of the glands. Clinically, there are two classes with lymphocytic infiltration that eventually causes severe damage of Sjögren’s syndrome: primary and secondary types. Primary Dehydration, malfunction of the salivary glands, or radiotherapy of Sjögren’s syndrome occurs independently, whereas secondary a change in the composition of saliva or reduced salivary flow [2]. the area of the salivary glands can cause xerostomia. The general Sjögren’s syndrome occurs concomitantly with other connective symptoms of xerostomia include a persistent oral burning sensation, tissue diseases [7]. Primary Sjögren’s syndrome is a common systemic autoimmune disease with a prevalence of 0.05-4.8% recurrent mucosal infections, greater periodontal disease, and [8]. Its incidence in women is approximately 9 times higher than eating difficulties, diminution in taste acuity, discomfort speaking, denture intolerance [3]. Xerostomia affects the mechanical process that in men [9]. Secondary Sjögren’s syndrome may be associated of providing moisture and lubricating the mouth with saliva, and the with rheumatoid arthritis, systemic lupus erythematosus, chemical, antimicrobial, remineralizing, and buffering functions of systemic sclerosis, multiple sclerosis, autoimmune thyroiditis, saliva [4]. A reduction in salivation is paralleled by a shift to highly and autoimmune hepatitis [10]. Patients with primary or secondary Sjögren’s syndrome have the same level of discomfort, [5]. Therefore, saliva plays important roles in protecting the oral complications, and severity of disease. Oral lesions including cariogenic microflora at the expense of non-cariogenic organisms cavity. Sjögren’s syndrome is one of the causes of xerostomia with angular cheilitis, atrophic glossitis, recurrent ulcerations, and destructive salivary and lacrimal glands due to abnormal infiltration fissurations of the tongue are usually found [11]. The pathogenesis of lymphocytes [6]. The attack on these exocrine glands may lead to of Sjögren’s syndrome is unknown, but it is believed to be caused by the development of xerostomia and keratoconjunctivitis sicca. Biomedical Journal of Scientific & Technical Research (BJSTR) 10170 Biomedical Journal of Scientific & Technical Research Volume 13- Issue 4: 2019 genetic predisposition, environmental and hormonal factors, and a Intervention disordered immune system [6,12]. The clinical symptoms including dryness of the mouth and The study medication was taken orally four times daily (QID) eyes, fatigue, and joint pain are usually found in 80% of patients years, those diagnosed as having primary or secondary Sjögren’s for 24 weeks. Inclusion criteria were men or women aged ≥20 with Sjögren’s syndrome [13]. To date, neither a cure for Sjögren’s syndrome in accordance with the 2002 revised European criteria, those who agreed to use medically acceptable and adequate gland secretion. Instead, treatment is generally symptomatic and contraceptive methods throughout the study, and those who syndrome nor a specific treatment is known to permanently restore supportive. Adequate immunotherapy may improve the systemic symptoms of Sjögren’s syndrome, including arthritis, pain, intersti- procedures, in the investigator’s opinion. Exclusion criteria were were reliable, cooperative, and likely to be compliant with study intolerance to pilocarpine; a history of uncontrolled asthma, chronic has no adequate response for the symptoms of dry mouth or dry bronchitis, and chronic obstructive pulmonary disease; history tial pulmonary fibrosis, and neuropathy [10], but immunotherapy eye [14]. However, prescription drugs including cevimeline and pi- of an uncontrolled cardiovascular disease; history of a renal or - tricyclic antidepressants, and cholinergic para-sympathomimetic locarpine are available to help stimulate salivary flow [10,13,15]. hepatic disease; and history or current treatment with β-blockers, inally extracted from Jaborandi (Pilocarpus microphyllus) [16]. It agents other than the study medication. Pilocarpine is a cholinergic parasympathomimetic alkaloid orig is a non-selective muscarinic receptor agonist. Its pharmacological Screening and Baseline Visit (Initiation of Trial actions can stimulate exocrine glands and result in diaphoresis, Treatment: Visit 1, Week 0) salivation, lacrimation, and gastric and pancreatic secretion. Pi- patients with xerostomia [17,18]. Pilocarpine has been approved locarpine can provide clinically significant symptomatic relief to Patients were checked for eligibility and introduced to the study for the treatment of xerostomia resulting from radiation damage to if their eligibility was confirmed. Patients were given an informed salivary glands and from Sjögren’s syndrome [10,17]. We aimed to consent form (ICF) to read and understand the study, and they signed, patients were enrolled in the study, and they underwent evaluate the safety of oral pilocarpine (Salicret, Meider Pharmaceu- decided independently whether to participate. Once the ICF was tical Co., Ltd.) for treating patients with Sjögren’s syndrome. baseline safety measurements, including physical examinations, 12-lead electrocardiography, and assessment of vital signs and body Methods weight. Patients’ medical history and previous medications were Study Design and Participants recorded, and a urine pregnancy test was performed for women of child-bearing age. First Returning Visit (Visit 2: Week 12, ±7 days) This single-arm interventional, post-market surveillance study returned for the safety evaluation and assessment of adverse - and Second Returning Visit (Visit 3: week 24, ±7 days)Patients aimed to recruit 135 patients from February 12, 2015 (first patient, - first visit) to March 20, 2017 (last patient, last visit), and it was con were performed at the investigator’s discretion when an AE or es General Hospital. This study was approved by the Institutional events (AEs) after 12 and 24 weeks of treatment. Laboratory tests ducted in Tri-Service General Hospital and Taichung Armed-Forc suspected AE was noted. All AEs and concomitant medications from Review Board of Tri-Service General Hospital (TSGHIRB number 2-103-05-140), and all patients in the study provided written in- shown in Table 1. formed consent the previous visit were documented. The flow chart of the study is Table 1: Flow chart of the study. Procedures Screening and baseline visits Returning (evaluation) visit 1 2 3 Visit 0 12 24 Week Not applicable ObtainVisit informedwindow (days) consent X ±7 ±7 Assess inclusion and exclusion X criteria Record demographic data and X medical history Record history of medication X Perform urine pregnancy test (applicable for women of child- X bearing age) Perform physical examinations X X X Assess vital signs X X X Conduct 12-lead ECG X X X Cite this article: Light for Colon Cancer. Biomed J Sci & Tech Res 13(4)-2019. BJSTR. MS.ID.002444. DOI: 10.26717/ BJSTR.2019.13.002444. 10171 Deng-Ho Yang, Feng-Cheng Liu, Chun-Chi Lu, San-Yuan Kuo, Shi-Jye Chu, Hsiang-Cheng Chen. Study of Phototoxicity of LED Biomedical Journal of Scientific & Technical Research Volume 13- Issue
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