替西帕肽 (TZP) 的随机对照试验显示，对 2 型糖尿病和/或肥胖症患者具有前所未有的降低血糖和体重的功效，且安全性与胰高血糖素样肽 1 受体激动剂 (GLP-1RA) 相似，主要特征胃肠道 (GI) 不良事件 (AE)。还讨论了对糖尿病视网膜病变、胰胆疾病和甲状腺髓样癌的担忧。我们的目的是调查 FDA 不良事件报告系统 (FAERS) 上市后监测数据库是否出现了相同的安全问题。使用 OpenVigil 2.1-MedDRA-v24 和 AERSMine（数据 2004Q1-2023Q3）来查询 FAERS 数据库。对胃肠道不良事件、糖尿病视网膜病变、胰胆疾病和甲状腺髓样癌的报告进行了调查。然后根据年龄、性别和主要嫌疑人的身份对分析进行筛选。将 TZP 的 AE 发生率与胰岛素、钠-葡萄糖协同转运蛋白 2 抑制剂、二甲双胍和 GLP-1RA 进行比较。胃肠道 [即恶心（ROR 4.01，95% CI 3.85-4.19）] 和胰胆疾病的报告不成比例 [即检测到胰腺炎（ROR 3.63，95% CI 3.15-4.19）]、糖尿病视网膜病变（ROR 4.14，95% CI 2.34-7.30）和甲状腺髓样癌（ROR 13.67，95% CI 4.35-42.96）。与 GLP-1RA 相比，TZP 表现出相似的 GI AE 和甲状腺髓样癌风险，并且大多数胰胆 AE 和糖尿病视网膜病变的风险较低。TZP 与特定 AE 风险增加相关。然而，其安全性与 GLP-1RA 相似，不会增加胰胆 AE、糖尿病视网膜病变和甲状腺髓样癌的风险。© 2024。作者。

Randomized controlled trials with tirzepatide (TZP) displayed unprecedented glucose and body weight lowering efficacy in individuals with type 2 diabetes and/or obesity and a safety profile similar to that of glucagon-like peptide-1 receptor agonists (GLP-1RA), mainly characterized by gastrointestinal (GI) adverse events (AE). Concerns on diabetic retinopathy, pancreato-biliary disorders, and medullary thyroid cancer were also addressed. We aimed to investigate whether the same safety issues emerged from the FDA Adverse Event Reporting System (FAERS) post-marketing surveillance database.OpenVigil 2.1-MedDRA-v24 and AERSMine (data 2004Q1-2023Q3) were used to query the FAERS database. Reports of GI AE, diabetic retinopathy, pancreato-biliary disorders, and medullary thyroid cancer were investigated. The analysis was then filtered for age, gender, and designation as primary suspect. AE occurrence with TZP was compared to insulin, sodium-glucose cotransporter-2 inhibitors, metformin, and GLP-1RA.Disproportionate reporting of GI [i.e., nausea (ROR 4.01, 95% CI 3.85-4.19)] and pancreato-biliary disorders [i.e., pancreatitis (ROR 3.63, 95% CI 3.15-4.19)], diabetic retinopathy (ROR 4.14, 95% CI 2.34-7.30), and medullary thyroid cancer (ROR 13.67, 95% CI 4.35-42.96) was detected. TZP exhibited a similar risk of GI AE and medullary thyroid cancer and a lower risk of most pancreato-biliary AE and diabetic retinopathy vs. GLP-1RA.TZP was associated with an increased risk of specific AE. However, its safety profile was similar to that of GLP-1RA, without increased risk of pancreato-biliary AE, diabetic retinopathy, and medullary thyroid cancer.© 2024. The Author(s).