Background: In patient of T2DM and HF, reduced ejection fraction (HFrEF) constitutes the majority of HF cases, posing significant risk of mortality. NYHA classification, recommended in global HF guidelines, independently predicts mortality. SGLT2i have shown to reduce the incidence of hospitalization for HF. Hence, this study was planned to evaluate the effectiveness of Remogliflozin in improving the NYHA class in patients of T2DM with HF.
Methods: In this prospective, multicentre study, 250 patients of T2DM with HFrEF having NYHA Class I to III, were enrolled. 125 patients were allocated each to Remogliflozin (R) and Empagliflozin (E) group.
Results: Baseline distribution of patients in NYHA class was comparable in both groups. At baseline, 4%, 78.4%, and 17.6% of the patients in R-group were in NYHA class I, II, and III respectively, which improved to 50.91% in class I, 42.73% in class II, and 6.36% in class III at week 24 (Figure 1). Similarly, in E-group, about 4.8%, 64.8%, and 30.4% of the patients were in NYHA class I, II, and III and improved to 48.5% in class I, 40.9% in class II, and 10.5% in class III at week 24. Percentage improvement in NYHA class by ≥1 grade was seen in both R and E-group (80% vs 76%) at 24 weeks. The positive improvement in NYHA class indicates that the treatment provided improved patient’s function class and QoL. Both groups showed significant improvement in echo parameters (LVEF, LVdd) with no new safety concerns reported.
Conclusion: The improvement in NYHA class was comparable between Remogliflozin and Empagliflozin in patients of T2DM patients and HF (HFrEF). These clinical benefits were irrespective of baseline NYHA class and was associated with early and sustained improvement in NYHA class over study duration.
H.V. Barkate: Employee; Glenmark Pharmaceuticals. Y. Panchal: None. S. Bhushan: None. S.Y. Choudhari: Employee; Glenmark Pharmaceuticals, Sun Pharmaceutical Industries Ltd. A.U. Petare: Employee; Glenmark Pharmaceuticals.