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)

There is limited data comparing two gliflozins on their effect on biomarkers in diabetic patients with chronic heart failure. A prospective, multicenter, active controlled, double-arm, investigator-initiated, interventional study enrolled 250 adults with type 2 diabetes mellitus (T2DM) and comorbid congestive heart failure (CHF; left ventricular ejection fraction [LVEF] <40%; N-terminal pro-B-type natriuretic peptide [NT-proBNP] >600 pg/mL). A total of 125 patients were allocated each to a 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. There 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 = .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 the R-group (P ≤ .001) and from 2283.98 ± 1759.15 pg/mL at baseline to 1395.33 ± 1304.18 pg/mL at 6 months in the E-group (P < .001). LVEF and LV volumes improved in both 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 events in any group. Remogliflozin and empagliflozin significantly improve 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.