Alenzi Khalidah A, Alsuhaibani Deemah, Batarfi Bader, Alshammari Thamir M
Society of Pharmacovigilance, Jeddah, Saudi Arabia.
Transformation, Planning, and Business Development Department, Tabuk Health Cluster, Tabuk, Saudi Arabia.
Front Pharmacol. 2024 May 27;15:1364110. doi: 10.3389/fphar.2024.1364110. eCollection 2024.
Pancreatitis is characterized by inflammation of the pancreas and significantly affects quality of life. Less than 5% of pancreatitis cases are drug-induced, but recent evidence suggests a substantial risk associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The aim of this study was to compare the risk of developing pancreatitis between those using GLP-1 RAs and those using sodium-glucose transport protein 2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors. This study was done using the FDA Adverse Event Reporting System (FAERS) database from 2019 to 2021. This database contains information from diverse submissions from healthcare providers, patients, and manufacturers. To ensure fairness and accuracy, the risk of pancreatitis associated with other hypoglycemic agents (SGLT2 inhibitors and DPP-4 inhibitors) was also investigated. Traditional and Bayesian statistical analysis methods were used to identify disproportionate statistics and included the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). A drug-adverse-event combination that met the criteria of all four indices was deemed a signal. The analysis of 2,313 pancreatitis reports linked to hypoglycemic agents revealed a predominant association with GLP-1 RA (70.2%) compared to DPP-4 inhibitors (15%) and SGLT2 (14.7%). Most of these reports involved female patients (50.4%), and the highest incidence occurred in those over 50 years old (38.4%). Additionally, 17.7% of the reports were associated with serious events. The ROR was significant for the risk of pancreatitis when using DPP-4 (13.2, 95% confidence interval (CI) 11.84-14.70), while the ROR for GLP-1 was 9.65 (95% CI 9.17-10.16). The EBGM was highest with DPP-4 (12.25), followed by GLP-1 (8.64), while IC was highest with DPP-4 inhibitors (3.61). Liraglutide had the greatest association with pancreatitis among the GLP-1 RAs (ROR: 6.83, 95% CI 6.60-7.07). The findings show that pancreatitis has a strong link with DPP-4 inhibitors and GPL1 agonists, which pose a greater risk. Among the GLP-1 agonist medications, liraglutide has been found to have an association with pancreatitis.
胰腺炎的特征是胰腺炎症，严重影响生活质量。不到5%的胰腺炎病例是药物性的，但最近的证据表明胰高血糖素样肽-1受体激动剂（GLP-1 RAs）存在重大风险。本研究的目的是比较使用GLP-1 RAs与使用钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂和二肽基肽酶4（DPP-4）抑制剂的患者发生胰腺炎的风险。本研究使用了2019年至2021年的美国食品药品监督管理局不良事件报告系统（FAERS）数据库。该数据库包含来自医疗保健提供者、患者和制造商的各种提交信息。为确保公平性和准确性，还调查了与其他降糖药物（SGLT2抑制剂和DPP-4抑制剂）相关的胰腺炎风险。采用传统和贝叶斯统计分析方法来识别不成比例的统计数据，包括报告比值比（ROR）、比例报告比（PRR）、经验贝叶斯几何均值（EBGM）和信息成分（IC）。符合所有四个指标标准的药物-不良事件组合被视为一个信号。对2313份与降糖药物相关的胰腺炎报告的分析显示，与DPP-4抑制剂（15%）和SGLT2（14.7%）相比，GLP-1 RA与之关联最为显著（70.2%）。这些报告大多涉及女性患者（50.4%），最高发病率出现在50岁以上的人群中（38.4%）。此外，17.7%的报告与严重事件相关。使用DPP-4时胰腺炎风险的ROR具有统计学意义（13.2，95%置信区间（CI）11.84 - 14.70），而GLP-1的ROR为9.65（95% CI 9.17 - 10.16）。EBGM以DPP-4最高（12.25），其次是GLP-1（8.64），而IC以DPP-4抑制剂最高（3.61）。在GLP-1 RAs中，利拉鲁肽与胰腺炎的关联最大（ROR：6.83，95% CI 6.60 - 7.07）。研究结果表明，胰腺炎与DPP-4抑制剂和GPL1激动剂有密切联系，它们带来的风险更大。在GLP-1激动剂药物中，已发现利拉鲁肽与胰腺炎有关联。
