Aim: With the widespread use of SGLT2i, various adverse events (AEs)
have been reported. This study aimed to describe the distribution of
SGLT2i-related AEs in different systems, quantify the association of
important medical events (IMEs) and SGLT2i regimens, and build a signal
profile of SGLT2i- induced IMEs. Methods: Data from 2015 Q1 to 2020 Q4
in the FDA Adverse Event Reporting System database (FAERS) were selected
to conduct disproportionality analysis. Two signal indicators, the
reported odds ratio (ROR) and information component (IC), were used to
evaluate the correlation between SGLT2i and IMEs. The lower end of the
95% confidence interval of IC (IC025) exceeding zero was deemed a
signal. For ROR, it was defined a signal if ROR025 over one, with at
least 3 cases. Results: A total of 45,771,436 records were involved,
including 111,564 records related to SGLT2i, with 38,366 records of
SGLT2i-induced IMEs. Overall, SGLT2i was significantly associated with
IMEs (IC=0.36, 95% CI: 0.35-0.38; ROR=1.44, 95% CI: 1.42-1.46). Most
SGLT2i-related adverse events occurred in monotherapy (92.93%).
Diabetic ketoacidosis was the most IMEs. Specifically, acute
osteomyelitis has the strongest signal of all SGLT2i (IC025=7.83), and
it was unique to canagliflozin. Diabetic ketoacidosis, acute kidney
injury, ketoacidosis, Fournier’s gangrene, and euglycemic diabetic
ketoacidosis were common to the four FDA-approved SGLT2i. Conclusion:
Our study demonstrated that different SGLT2i regimens lead to different
important adverse events, but there are overlapping events. Early
identification and management of SGLT2i-associated IMEs are essential
for clinical practice.
Safety of SGLT2 Inhibitors: A Pharmacovigilance Study From 2015 to 2020 Based on FDA Adverse Event Report System Database
