Safety of Empagliflozin in Patients with Type 2 Diabetes Mellitus in Saudi Arabia: A Post-Authorisation Safety Study

Background: Empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor is used as monotherapy or in combination for lowering the elevated blood glucose level patients with type 2 diabetes mellitus (T2DM). It often associated certain adverse reactions (urinary tract infection (UTI), ketoacidosis (DKA), and genital infections). Thus, Saudi Food Drug Administration requested post-authorisation safety study to monitor of empagliflozin during defined observation period. Methodology: The local, comparator, non-interventional, regulatory post-marketing using “new user” design was conducted T2DM, treated (10 25 mg) dipeptidyl peptidase-4 (DPP-4) inhibitors (NCT03764631). Study from 2018 2020, wherein each patient followed up 12 months after index Incidence occurrence DKA, severe UTIs, volume depletion dehydration were observed along metformin, insulin treatment complexity status events Ramadan All data collected analysed descriptive statistics. Results: Among 1502 enrolled (empagliflozin [n = 751] DPP-4 751]), 0.1% (n 1) group Conclusion: Empagliflozin well tolerated over period months, no concerns favourable benefit/risk ratio.