Short-term Effects of Empagliflozin on Exercise Tolerance in Type 2 Diabetic Patients with Heart Failure with Preserved Ejection Fraction: A Randomized Controlled Trial (EMPOWERMENT study)
Abstract
Abstract Background Diabetes is a risk factor for heart failure with preserved ejection fraction (HFpEF). Sodium-glucose cotransporter-2 inhibitors have become a standard treatment to improve clinical outcomes in HFpEF patients. However, the short-term effects of empagliflozin on exercise tolerance in these patients with type 2 diabetes mellitus (T2DM) remains unknown. Methods This study included patients with HFpEF (ejection fraction ≥ 50% by echocardiography) aged 20–85 years, with hemoglobin A1c values between 6.0% and 10%, B-type natriuretic peptide (BNP) concentrations > 35 pg/ml, and New York Heart Association (NYHA) class II or III symptoms. The patients were randomly assigned to receive empagliflozin (10 mg daily) or sitagliptin (50 mg daily) for 3 months. The primary endpoint was the change (from baseline to 3 months) in peak oxygen uptake (VO2) on cardiopulmonary exercise testing (CPET). The secondary endpoints were changes in the anaerobic threshold, BNP concentrations, NYHA class, left/right ventricular ejection fraction (LV/RVEF) on magnetic resonance imaging, muscle mass, and muscle strength. Results We studied 40 patients, and 22 were assigned to the empagliflozin group and 18 to the sitagliptin group. Data from 33 patients (19 with empagliflozin, 14 with sitagliptin) were analyzed. No significant difference in peak VO2 improvement was found between groups (Empagliflozin: 0.87 ml/kg/min; Sitagliptin: 0.1 ml/kg/min; p = 0.35). The change in muscle strength…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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