关键词: Case reports Detection Disproportionality analysis Pancreatitis Pharmacovigilance Signal Sodium-glucose cotransporter-2 inhibitors

Mesh : Humans Sodium-Glucose Transporter 2 Inhibitors / adverse effects Pharmacovigilance Adverse Drug Reaction Reporting Systems Retrospective Studies Canada Pancreatitis / chemically induced diagnosis epidemiology

来  源:   DOI:10.1007/s11096-022-01476-7

Abstract:
BACKGROUND: In recent times, pancreatitis has been one of the most frequently reported adverse events for sodium-glucose cotransporter-2 (SGLT2) inhibitors.
OBJECTIVE: To evaluate the potential association between SGLT2 inhibitors and the risk of pancreatitis by analyzing the spontaneous reports through disproportionality analysis and reviewing case reports.
METHODS: A retrospective case/non-case study was conducted using spontaneous reports from the FDA Adverse Event Reporting System (FAERS), VigiBase, and the Canadian Adverse Reaction Database (CARD). Disproportionality analysis was performed by calculating the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and the Information Component (IC). In parallel, a review of case reports was conducted on SGLT2 inhibitors-induced pancreatitis.
RESULTS: A total of 524, 510, and 40 spontaneous reports of pancreatitis suspected to be caused by SGLT2 inhibitors were identified from FAERS, VigiBase, and CARD, respectively. Through the disproportionality analysis of FAERS data, a signal was identified between the SGLT2 inhibitors and pancreatitis, with empagliflozin having highest risk [PRR = 3.9; Lower Bound (LB) ROR = 3.4; IC025 = 1.7], followed by canagliflozin [PRR = 3.6; LB ROR = 3.2; IC025 = 1.6], and dapagliflozin [PRR = 3.2; LB ROR = 2.7; IC025 = 1.4]. VigiBase and CARD data analyses reiterated the findings of FAERS. Thirteen case reports identified from a systematic literature search strengthened these findings and highlighted the importance of physical examination and laboratory parameters for the early diagnosis of pancreatitis.
CONCLUSIONS: The current study found a potential risk of pancreatitis with the use of SGLT2 inhibitors. There is an urgent need to thoroughly investigate the same and take the necessary action to avoid or minimize the risk.
摘要:
背景:最近,胰腺炎是钠-葡萄糖协同转运蛋白-2(SGLT2)抑制剂最常报告的不良事件之一.
目的:通过不成比例分析和回顾病例报告,评估SGLT2抑制剂与胰腺炎风险之间的潜在关联。
方法:使用FDA不良事件报告系统(FAERS)的自发报告进行了回顾性病例/非病例研究,VigiBase,和加拿大不良反应数据库(CARD)。不相称性分析通过计算比例报告比率(PRR)进行,报告赔率比(ROR),和信息组件(IC)。并行,我们对SGLT2抑制剂诱导的胰腺炎的病例报告进行了综述.
结果:从FAERS中确定了总共524、510和40例疑似由SGLT2抑制剂引起的胰腺炎的自发报告,VigiBase,还有卡,分别。通过对FAERS数据的不相称性分析,在SGLT2抑制剂和胰腺炎之间确定了信号,依帕列净风险最高[PRR=3.9;下限(LB)ROR=3.4;IC025=1.7],其次是canagliflozin[PRR=3.6;LBROR=3.2;IC025=1.6],和达格列净[PRR=3.2;LBROR=2.7;IC025=1.4]。Vigibase和CARD数据分析重申了FAERS的发现。从系统的文献检索中确定的13例病例报告加强了这些发现,并强调了体格检查和实验室参数对早期诊断胰腺炎的重要性。
结论:目前的研究发现使用SGLT2抑制剂有潜在的胰腺炎风险。迫切需要彻底调查这种情况,并采取必要的行动来避免或尽量减少风险。
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