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

Abstract

Background: Empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor is used as a monotherapy or in combination for lowering the elevated blood glucose level in patients with type 2 diabetes mellitus (T2DM). It is often associated with certain adverse reactions (urinary tract infection (UTI), diabetes ketoacidosis (DKA), and genital infections). Thus, the Saudi Food and Drug Administration requested a post-authorisation safety study to monitor the safety of empagliflozin during the defined observation period. Methodology: The local, comparator, non-interventional, regulatory post-marketing study using “new user” design was conducted in patients with T2DM, treated with empagliflozin (10 or 25 mg) and dipeptidyl peptidase-4 (DPP-4) inhibitors (NCT03764631). Study was conducted from 2018 to 2020, wherein each patient was followed up for 12 months after the index period. Incidence and occurrence of DKA, severe UTIs, volume depletion and dehydration were observed along with metformin, insulin and treatment complexity status and adverse events in the index and Ramadan period. All data collected were analysed using descriptive statistics. Results: Among the 1502 patients enrolled (empagliflozin [n = 751] and DPP-4 inhibitors [n = 751]), 0.1% patients (n = 1) in each group and <1% patients (n = 13) (0.8% [n = 6]: empagliflozin group; 0.9% [n = 7]: DPP-4 inhibitor group) reported the incidence of DKA and volume depletion, respectively. No severe UTIs or dehydration was evident in either group in the index period. No patients reported T2DM-associated complications during the Ramadan period. Metformin, insulin, and treatment complexity status were also evaluated during the study. Overall, 8.1% of patients (n = 121) reported adverse events in the index period while only 0.3% of patients (n = 4) reported adverse events during the Ramadan period. Comparable decline in mean glycated haemoglobin, and no major change in vital signs, along with 81.3% of patients (n = 1221) confirming concomitant medications were noted. Conclusion: Empagliflozin was well tolerated over a period of 12 months, with no safety concerns and a favourable benefit/risk ratio.