Are Two Gliflozins Different: A Prospective Multicenter Randomized Study to Assess Effect of Remogliflozin Compared With Empagliflozin on Biomarkers of Heart Failure in Indian Patients With Type 2 Diabetes Mellitus with Chronic Heart Failure (REMIT-HF Study)

Abstract

BackgroundThere is limited data comparing two gliflozins on their effect on biomarkers in diabetic patients with chronic heart failure. MethodsA prospective, multicenter, active controlled, double-arm, investigator-initiated, interventional study enrolled 250 adults with T2DM and comorbid CHF (LVEF<40%; NT-proBNP >600pg/ml). 125 patients were allocated each to Remogliflozin (R) and Empagliflozin (E) group and followed up for 24 weeks. The primary endpoint was the mean percentage change from baseline in NT-proBNP level after 24 weeks. ResultsThere was significant improvement from baseline in mean NT-proBNP level in both groups after 24 weeks however there was no significant difference between the two groups (p= 0.214). The mean NT-proBNP level improved from 2078.15±1764.70 pg/ml at baseline to 1185.06±1164.21 pg/ml at 6 months in R-group (p≤0.001) and from 2283.98±1759.15 pg/ml at baseline to 1395.33±1304.18 pg/ml at 6 months in E-group (p= <0.001). Left ventricular ejection fraction (LVEF) and LV volumes improved in both the groups. The glycemic parameters (HbA1c, FPG and PPG) demonstrated a significant reduction from baseline to week 24 in both groups. Similar improvement was seen in heart rate, blood pressure and weight reduction over 6 months in both groups. There was no drug related serious adverse event in any group. ConclusionRemogliflozin and Empagliflozin significantly improves glycemic parameters and NT-proBNP levels as the index of the therapeutic effects in T2DM patients with CHF. The positive effects are comparable in both groups.