RETROSPECTIVE STUDY OF EFFICACY AND SAFETY OF THE COMBINATION LINAGLIPTIN, EMPAGLIFLOZIN, METFORMIN IN THE MANAGEMENT OF TYPE 2 DIABETES IN INDIA IN THE REAL-WORLD SETTING

Abstract

Background: Type 2 diabetes mellitus (T2DM) is a progressive disorder with high cardiovascular (CV) risk, often inadequately controlled on monotherapy. This study aimed to evaluate real-world efficacy, safety, CV outcomes, tolerability and adherence of the empagliflozin, sitagliptin and metformin fixed-dose combination (FDC) in Indian patients. Methods: This questionnaire-based study collected responses from healthcare practitioners (HCPs) in India regarding their last 10 patients with T2DM who received the linagliptin, empagliflozin and metformin combination. The study assessed the data on baseline glycemia, prior therapy, HbA1c (glycated hemoglobin) thresholds, glycemic target achievement, CV risk, adverse events, and adherence to the combination. Results: A total of 571 HCPs were involved in the study. In real-world practice, 30.82% of HCPs reported that all of their last 10 patients on two-drug therapy had HbA1c >7.0%. At HbA1c levels of 7.6-8.0%, 33.27% of HCPs initiated the triple combination of linagliptin, empagliflozin, and metformin. The most common CV risk factors observed were uncontrolled blood glucose (40.11%) and hypertension (32.75%). After 6 months of therapy, 34.15% of patients achieved target HbA1c, with 38.35% of HCPs reporting a 1.25-1.5% reduction and 31.00% reporting 0.75-1.0% reduction after 4 months in newly diagnosed patients. Weight loss was noted in 63.92% of patients, while hypoglycemia was reported in 38.18%. The triple FDC was rated excellent by HCPs for efficacy (50.96%), safety (47.81%), and patient adherence (50.79%). Conclusion: The fixed-dose combination of empagliflozin, linagliptin, and metformin demonstrated effective glycemic control, favorable weight outcomes, and good tolerability, while addressing key cardiovascular and renal risk factors in routine clinical practice.