Empagliflozin in Non-diabetic Heart Failure Patients With Reduced Ejection Fraction - EMPATROPISM

Jan 21, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Boehringer Ingelheim
Date Presented:
11/13/2020
Date Published:
11/13/2020
Date Updated:
01/21/2021
Original Posted Date:
11/13/2020
References

Contribution To Literature:

The EMPATROPISM trial showed that empagliflozin was superior to placebo at improving cardiac remodeling.

Description:

The goal of the trial was to evaluate empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, compared with placebo among non-diabetic patients with heart failure with reduced ejection fraction (HFrEF).

Study Design

  • Randomized
  • Parallel
  • Placebo

Non-diabetic patients with HFrEF were randomized to empagliflozin 10 mg daily (n = 42) versus placebo (n = 42).

  • Total number of enrollees: 84
  • Duration of follow-up: 6 months
  • Mean patient age: 61.9 years
  • Percentage female: 36%

Inclusion criteria:

  • Ambulatory patients 18-85 years of age
  • HF with New York Heart Association (NYHA) class II-III symptoms
  • Left ventricular ejection fraction (LVEF) <50%
  • Stable symptoms and therapy for HF within the last 3 months

Exclusion criteria:

  • Pregnant or lactating women
  • Any history of diabetes
  • Acute coronary syndrome or cardiac surgery within the last 3 months
  • Cancer or other life-threatening condition
  • Pancreatitis
  • Estimated glomerular filtration rate <45 ml/kg/min
  • Use of continuous parental inotropic agents
  • Systolic blood pressure <90 mm Hg
  • Recreational drugs and/or excessive alcohol
  • Psychiatric disease incompatible with being in study
  • Any contraindication to magnetic resonance imaging
  • Any other medical or physical condition precluding study participation

Other salient features/characteristics:

  • Mean EF: 36.5%

Principal Findings:

The co-primary outcome, change in LV end-systolic volume from baseline to 6 months, was -26.6 ml in the empagliflozin group compared with -0.5 ml in the placebo group (p < 0.001).

The co-primary outcome, change in LV end-diastolic volume from baseline to 6 months, was -25.1 ml in the empagliflozin group compared with -1.5 ml in the placebo group (p < 0.001).

Secondary outcomes:

  • Change in LVEF from baseline to 6 months: 6.0% in the empagliflozin group compared with -0.1% in the placebo group (p < 0.001)
  • Change in LV mass from baseline to 6 months: -17.8 g/m2 in the empagliflozin group compared with 4.1 g/m2 in the placebo group (p < 0.001)
  • Change in peak VO2 from baseline to 6 months: 1.1 ml/kg/min in the empagliflozin group compared with -0.5 ml/kg/min in the placebo group (p = 0.017)
  • Change in 6-minute walk test from baseline to 6 months: 82 m in the empagliflozin group compared with -35 m in the placebo group (p < 0.001)

Interpretation:

Among patients with HFrEF, empagliflozin was beneficial. This agent was associated with improvements in LV volume, LV mass, and LV function compared with placebo. This medication was also associated with improvements in cardiopulmonary capacity and walking distance versus placebo. Empagliflozin is an SGLT2 inhibitor, which is a Food and Drug Administration (FDA) approved medication to lower blood glucose in individuals with type 2 diabetes. The results of this trial find that empagliflozin could be beneficial for the treatment of HFrEF, independent of glycemic status.

References:

Santos-Gallego CG, Vargas-Delgado AP, Requena JA, et al., on behalf of the EMPA-TROPISM (ATRU-4) Investigators. Randomized Trial of Empagliflozin in Non-Diabetic Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol 2021;77:243-55.

Editorial Comment: Goldberg LR. The Pleiotropic Effects of SGLT2 Inhibitors: Remodeling the Treatment of Heart Failure. J Am Coll Cardiol 2021;77:256-8.

Presented by Dr. Juan J. Badimon at the American Heart Association Virtual Scientific Sessions, November 13, 2020.

Clinical Topics: Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Acute Heart Failure, Diabetes and Cardiometabolic Disease, Vascular Medicine, Prevention

Keywords: AHA20, AHA Annual Scientific Sessions, Blood Glucose, Diabetes Mellitus, Type 2, Heart Failure, Sodium-Glucose Transporter 2, Stroke Volume, Ventricular Dysfunction, Left, Ventricular Function, Left, Ventricular Remodeling


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