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.
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.