Real-World Prescribing Patterns and Clinical Characteristics of Patients With Type 2 Diabetes Mellitus Receiving Empagliflozin-Sitagliptin-Metformin Fixed-Dose Combination Therapy.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is associated with substantial cardiovascular and renal morbidity, necessitating individualized treatment strategies that target multiple pathophysiological mechanisms. Triple fixed-dose combination (FDC) therapy comprising empagliflozin, sitagliptin, and metformin (ESM) is used in routine clinical practice; however, real-world data describing the clinical characteristics and prescribing patterns of patients receiving this combination in India remain limited. METHODS: This multicentric, retrospective, cross-sectional real-world evidence study evaluated demographic characteristics, clinical profiles, comorbidities, glycemic parameters, renal function, and prescribing patterns among adult patients with T2DM receiving empagliflozin-, sitagliptin-, and metformin-based triple FDC therapy in India. Patients receiving empagliflozin 25 mg + sitagliptin 100 mg + metformin 1000 mg (ESM-25) or empagliflozin 10 mg + sitagliptin 100 mg + metformin 1000 mg (ESM-10) were included in the analysis. RESULTS: A total of 12,843 patients were included, comprising 7,060 receiving ESM-25 therapy and 5,783 receiving ESM-10 therapy. Most patients were aged >50 years (64.2% in both groups), and males constituted 60.4% and 61.2% of the ESM-25 and ESM-10 groups, respectively. Physicians and diabetologists accounted for the majority of prescriptions. Comorbidities were documented in the available medical records for 12.0% of patients, with hypertension and cardiovascular disease (CVD) being the most frequently recorded conditions. Patients receiving ESM-25 therapy demonstrated higher glycemic parameters than those receiving ESM-10 therapy, including HbA1c (8.80% vs 8.68%), fasting plasma glucose (182.38 mg/dL vs 163.96 mg/dL), and postprandial plasma glucose levels (247.99 mg/dL vs 216.54 mg/dL). Differences between dosage groups were observed for urinary albumin-to-creatinine ratio, LDL cholesterol, and triglyceride levels. CONCLUSION: Empagliflozin-based triple FDC therapy was prescribed among Indian patients with T2DM, particularly older adults with cardiometabolic comorbidities. Distinct prescribing patterns and clinical characteristics observed between ESM-25 and ESM-10 therapy may reflect individualized treatment selection in routine clinical practice.