%0 Journal Article
%T Pharmacovigilance study for SGLT 2 inhibitors- Safety review of real-world data & randomized clinical trials.
%A Bhanushali KB
%A Asnani HK
%A Nair A
%A Ganatra S
%A Dani SS
%J Curr Probl Cardiol
%V 49
%N 9
%D 2024 Sep 22
%M 38789017
%F 16.464
%R 10.1016/j.cpcardiol.2024.102664
%X <B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.