Empagliflozin (SGLT2 inhibitor) and linagliptin (DPP-4 inhibitor) is a Fixed Dose Combination (FDC) with limited real-world evidence. We assessed the efficacy of this novel FDC in the real world Indian setting by analyzing the mean change in 12-week values of the glycemic (HbA1c and FPG) and extra-glycemic parameters (SBP, DBP, eGFR and body weight) as compared to the baseline values at the point of initiation of FDC in 498 patients. (Table). The patients enrolled were independently naïve to both DPP IV inhibitor and SGLT2 inhibitor therapy. Unpaired t test and ANOVA were utilised for statistical analysis. The mean age was 61 years (SD ± 7.6). The ongoing treatment in 20% (n=100), 43% (n=214), 38% (n=189), 26% (n=127) were metformin (M), combination of M and sulfonylureas (SU), combination of M, SU and voglibose, and insulin, respectively. The mean change in HbA1c, FPG, SBP, DBP, eGFR and body weight was -1.1%, -45 mg/dl, -12 mmHg, -5 mmHg, 5 mL/min/1.73m2, -5 kg (p<0.0001), respectively. 23.9 % patients (n=119) achieved HbA1c < 7%. 36.8% (n=183) patients achieved FPG reductions ≥100mg/dl. Six patients reported clinically evident hypoglycaemia which was managed symptomatically. There was a meaningful change and a substantial quantum of improvement in glycemic, metabolic and renal parameters. The results need to be validated through a long-term larger study.
A. Gupta: None. M. Khalse: None. A. Bhargava: None.