{Reference Type}: Journal Article
{Title}: Pharmacovigilance study for SGLT 2 inhibitors- Safety review of real-world data & randomized clinical trials.
{Author}: Bhanushali KB;Asnani HK;Nair A;Ganatra S;Dani SS;
{Journal}: Curr Probl Cardiol
{Volume}: 49
{Issue}: 9
{Year}: 2024 Sep 22
{Factor}: 16.464
{DOI}: 10.1016/j.cpcardiol.2024.102664
{Abstract}: <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.