Randomized Trial of Empagliflozin in Non-Diabetic Patients with Heart Failure and Reduced Ejection Fraction

Link to article at PubMed

J Am Coll Cardiol. 2020 Nov 9:S0735-1097(20)37753-6. doi: 10.1016/j.jacc.2020.11.008. Online ahead of print.

ABSTRACT

BACKGROUND: Large clinical trials established the benefits of SGLT2 inhibitors in patients with diabetes and with heart failure with reduced ejection fraction (HFrEF). The early and significant improvement in clinical outcomes is likely explained by effects beyond a reduction in hyperglycemia OBJECTIVES: To assess the effect of empagliflozin on LV function and volumes, functional capacity and quality of life (QoL) in non-diabetic HFrEF patients.

METHODS: In this double-blind, placebo-controlled trial, non-diabetic HFrEF patients (n=84) were randomized to empagliflozin or placebo for six months. The primary endpoint was change in left ventricle end-diastolic volume (LVEDV) and left ventricle end-systolic volume (LVESV) assessed by cardiac magnetic resonance. Secondary endpoints included changes in LV mass, LVEF, peak oxygen consumption in the cardiopulmonary exercise test, 6-minute walk test, and quality of life RESULTS: Empagliflozin was associated with a significant reduction of LVEDV (-25.1±26.0 vs -1.5±25.4mL for empagliflozin vs placebo, respectively, p<0.001) and LVESV (-26.6±20.5 vs -0.5±21.9 mL for empagliflozin vs placebo, p<0.001). Empagliflozin was associated with reductions in LV mass (-17.8±31.9 vs 4.1±13.4 g, for empagliflozin vs placebo, respectively, p<0.001) and improvements in LVEF (6±4.2 vs -0.1±3.9 p<0.001). Patients who received empagliflozin had significant improvements in peak O2 consumption (1.1±2.6 vs -0.5±1.9mL/min/kg for empagliflozin vs placebo, respectively, p=0.017), oxygen uptake efficiency slope (111±267 vs -146±318, p<0.001), as well as in 6-minute walk test (81±64 vs -35±68 meters, p<0.001) and quality of life (KCCQ-12: 21±18 vs 2±15, p<0.001).

CONCLUSIONS: Empagliflozin administration to non-diabetic HFrEF patients significantly improves LV volumes, LV mass, LV systolic function, functional capacity, and quality of life when compared with placebo. Our observations strongly support a role for SGLT2 inhibitors in the treatment of HFrEF patients independently of their glycemic status.

CONDENSED ABSTRACT: In this double-blind, placebo-controlled, randomized EMPATROPISM clinical trial, empagliflozin administration to non-diabetic HFrEF patients on top of optimal medical treatment ameliorated cardiac remodeling, reduced LV volumes, decreased LV mass, increased LV systolic function, enhanced functional capacity (both peak oxygen consumption and 6-minute walk test), and improved quality of life when compared with placebo. The results of the EMPATROPISM trial support the use of SGLT2 inhibitors in the treatment of HFrEF patients independently of their diabetic status.

PMID:33197559 | DOI:10.1016/j.jacc.2020.11.008

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