Pharmacovigilance study for SGLT 2 inhibitors- Safety review of real-world data & randomized clinical trials

Abstract

Purpose: 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.

Keywords: Adverse events; Disproportionality analysis; Randomized clinical trial; Real world pharmacovigilance; SGLT 2 inhibitors; Spontaneous reporting systems.