I Caruso, L Di Gioia, S Di Molfetta, M Caporusso, A Cignarelli, G P Sorice, L Laviola, F Giorgino
{"title":"Tirzepatide 的真实世界安全概况:对 FDA 不良事件报告系统 (FAERS) 数据库的药物警戒分析。","authors":"I Caruso, L Di Gioia, S Di Molfetta, M Caporusso, A Cignarelli, G P Sorice, L Laviola, F Giorgino","doi":"10.1007/s40618-024-02441-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":48802,"journal":{"name":"Journal of Endocrinological Investigation","volume":null,"pages":null},"PeriodicalIF":5.4000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11473560/pdf/","citationCount":"0","resultStr":"{\"title\":\"The real-world safety profile of tirzepatide: pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.\",\"authors\":\"I Caruso, L Di Gioia, S Di Molfetta, M Caporusso, A Cignarelli, G P Sorice, L Laviola, F Giorgino\",\"doi\":\"10.1007/s40618-024-02441-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>TZP was associated with an increased risk of specific AE. 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引用次数: 0
摘要
研究目的使用替扎帕肽(TZP)的随机对照试验显示,该药对 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疗效,其安全性与胰高血糖素样肽-1 受体激动剂(GLP-1RA)相似,主要表现为胃肠道(GI)不良事件(AE)。糖尿病视网膜病变、胰胆功能紊乱和甲状腺髓样癌等问题也受到关注。我们旨在调查 FDA 不良事件报告系统(FAERS)上市后监测数据库中是否也出现了同样的安全性问题:方法:使用 OpenVigil 2.1-MedDRA-v24 和 AERSMine(2004Q1-2023Q3 数据)查询 FAERS 数据库。对消化道 AE、糖尿病视网膜病变、胰胆管疾病和甲状腺髓样癌的报告进行了调查。然后根据年龄、性别和主要疑似病例进行筛选分析。将 TZP 的 AE 发生率与胰岛素、钠-葡萄糖共转运体-2 抑制剂、二甲双胍和 GLP-1RA 进行了比较:结果:发现胃肠道疾病[即恶心(ROR 4.01,95% CI 3.85-4.19)]和胰胆疾病[即胰腺炎(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)的报告比例偏高。与GLP-1RA相比,TZP发生消化道AE和甲状腺髓样癌的风险相似,而发生大多数胰胆管AE和糖尿病视网膜病变的风险较低:结论:TZP 与特定 AE 风险增加有关。结论:TZP 会增加特定 AE 的风险,但其安全性与 GLP-1RA 相似,不会增加胰胆管 AE、糖尿病视网膜病变和甲状腺髓样癌的风险。
The real-world safety profile of tirzepatide: pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.
Purpose: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
期刊介绍:
The Journal of Endocrinological Investigation is a well-established, e-only endocrine journal founded 36 years ago in 1978. It is the official journal of the Italian Society of Endocrinology (SIE), established in 1964. Other Italian societies in the endocrinology and metabolism field are affiliated to the journal: Italian Society of Andrology and Sexual Medicine, Italian Society of Obesity, Italian Society of Pediatric Endocrinology and Diabetology, Clinical Endocrinologists’ Association, Thyroid Association, Endocrine Surgical Units Association, Italian Society of Pharmacology.