Abstract：
OBJECTIVE: Despite effectiveness of sodium-glucose cotransporter 2 (SGLT 2) inhibitors, concerns have been raised about the potential side effects of these drugs. Thus, a pharmaco-vigilance study was designed that aims to identify any discrepancies between the reported adverse events & assess the safety profile of SGLT2 inhibitors.
METHODS: We studied diabetic ketoacidosis (DKA), euglycemic DKA, amputation, urinary tract infection (UTI), mycotic genital infection & hypotension associated with empagliflozin, dapagliflozin, canagliflozin & ertugliflozin in RCTs and reporting databases. WHO\'s VigiBase, FAERS, EMA\'s EudraVigilance & DAEN were thoroughly studied to obtain spontaneously reported real-world adverse events.
RESULTS: Different SGLT2 inhibitors exhibit varied side effect profiles. Additionally, the findings suggest that adverse events may be more likely to occur in a broader population in the real world than in a highly inclusive clinical trial subset CONCLUSION: Our study provides comparison of the real world reported adverse events to adverse events reported in the clinical trials studying the efficacy of SGLT 2 inhibitors.
METHODS: We studied diabetic ketoacidosis (DKA), euglycemic DKA, amputation, urinary tract infection (UTI), mycotic genital infection & hypotension associated with empagliflozin, dapagliflozin, canagliflozin & ertugliflozin in RCTs and reporting databases. WHO\'s VigiBase, FAERS, EMA\'s EudraVigilance & DAEN were thoroughly studied to obtain spontaneously reported real-world adverse events.
RESULTS: Different SGLT2 inhibitors exhibit varied side effect profiles. Additionally, the findings suggest that adverse events may be more likely to occur in a broader population in the real world than in a highly inclusive clinical trial subset CONCLUSION: Our study provides comparison of the real world reported adverse events to adverse events reported in the clinical trials studying the efficacy of SGLT 2 inhibitors.
摘要：
目的：尽管钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂有效，人们对这些药物的潜在副作用表示担忧。因此，我们设计了一项药物警戒研究,目的是确定报告的不良事件之间的任何差异,并评估SGLT2抑制剂的安全性.
方法：我们研究了糖尿病酮症酸中毒（DKA），正常血糖DKA,截肢,尿路感染（UTI），真菌性生殖器感染和与依帕列净相关的低血压，dapagliflozin,RCT和报告数据库中的canagliflozin和ertuggliflozin。WHO的VigiBase,FAERS,对EMA的EudraVigilance和DAEN进行了彻底研究，以获得自发报告的真实世界不良事件。
结果：不同的SGLT2抑制剂表现出不同的副作用。此外,研究结果表明,不良事件可能更容易发生在现实世界中更广泛的人群中,而不是在具有高度包容性的临床试验子集中。结论:我们的研究提供了现实世界中报道的不良事件与研究SGLT2抑制剂疗效的临床试验中报道的不良事件的比较.
方法：我们研究了糖尿病酮症酸中毒（DKA），正常血糖DKA,截肢,尿路感染（UTI），真菌性生殖器感染和与依帕列净相关的低血压，dapagliflozin,RCT和报告数据库中的canagliflozin和ertuggliflozin。WHO的VigiBase,FAERS,对EMA的EudraVigilance和DAEN进行了彻底研究，以获得自发报告的真实世界不良事件。
结果：不同的SGLT2抑制剂表现出不同的副作用。此外,研究结果表明,不良事件可能更容易发生在现实世界中更广泛的人群中,而不是在具有高度包容性的临床试验子集中。结论:我们的研究提供了现实世界中报道的不良事件与研究SGLT2抑制剂疗效的临床试验中报道的不良事件的比较.
