• Heart failure

Empagliflozin Reduces Risk of Cardiovascular Death and Hospitalization Rate in Heart Failure

Ingelheim, Germany and Indianapolis, USA – Results from the phase III EMPEROR-Reduced study in adults with heart failure with reduced ejection fraction (with and without diabetes) showed that empagliflozin was associated with a significant 25 percent relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalization due to heart failure.1 The study investigated the effect of adding empagliflozin (10 mg) compared with placebo to standard treatment.1 The results were presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology,3 and published in The New England Journal of Medicine.1

The results of the primary endpoint were consistent in subgroups with and without type 2 diabetes.1 Key secondary end point analyses from the trial showed that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent.1 In addition, the decline in eGFR, an indicator of renal function decline, was slower with empagliflozin than with placebo.1

  • Empagliflozin significantly reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed the decline in renal function.1
  • Results were consistent in subgroups with and without type 2 diabetes.1
  • Heart failure is the leading cause of hospitalization in the United States and Europe.2
  • Results from the phase III EMPEROR-Reduced study were published in the New England Journal of Medicine1.

In an exploratory analysis, the absolute risk reduction observed in the primary end point of the EMPEROR-Reduced trial corresponded to a number needed to treat of 19 patients over 16 months to prevent cardiovascular death or hospitalization for heart failure.1 Additional exploratory analysis showed that empagliflozin reduced the relative risk of a composite renal endpoint*, including end-stage renal disease and profound loss of renal function, by 50 percent.1

For EMPEROR-Reduced, efficacy results were achieved with a simple dosing regimen, with once-daily administration and no need for titration.1 The safety profile was similar to the well-established safety profile of empagliflozin.1 There were no clinically significant differences in adverse events such as hypovolemia (decreased blood volume), hypotension (low blood pressure), volume depletion (fluid loss), renal insufficiency (poor kidney function), hyperkalemia (high potassium), or hypoglycemia (low blood sugar) compared with placebo.1

Heart failure affects more than 60 million people worldwide,4 with more than one million people hospitalized for the condition each year in the United States and Europe.2 Heart failure occurs when the heart cannot pump enough blood to the rest of the body and is the most common and severe complication of a heart attack.5,6 People with heart failure often experience shortness of breath and fatigue, which can severely affect their quality of life.7,8 Individuals with heart failure often also have impaired renal function, which can significantly affect prognosis.9

*Ejection fraction is a measure of the percentage of blood that the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle fills with blood again.

 

Literature:

  1. Ponikowski P, Anker SD, AlHabib KF: Heart Failure: preventing disease and death worldwide. ESC Heart Fail. 2014;1(1): 4-25.
  2. Ambrosy A, Fonarow G, Butler J, et al: The Global Health and Economic Burden of Hospitalizations for Heart Failure. Lessons Learned From Hospitalized Heart Failure Registries. J Am Coll Cardiol. 2014;63(12): 1123-1133.
  3. Solomon S, Dobson J, Pocock S, et al: Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure. Circulation. 2007;116(13): 1482-1487.
  4. American Heart Association. Ejection Fraction Heart Failure Measurement. Available at: www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement. Last exam: July 2020.
  5. American Heart Association. Warning Signs of Heart Failure. Available at: www.heart.org/en/health-topics/heart-failure/warning-signs-of-heart-failure. Last exam: July 2020.
  6. ClinicalTrials.gov. Empagliflozin outcome trial in Patients With chronic heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved). Available at: https://clinicaltrials.gov/ct2/show/NCT03057951. Last check: July 2020.
  7. Harper A, Patel H, Lyon A: Heart failure with preserved ejection fraction. Clin Med (Lond). 2018;18(Suppl 2): s24-s29.
  8. ClinicalTrials.gov. Empagliflozin outcome trial in Patients With chronic heart Failure With Reduced Ejection Fraction (EMPEROR-Reduced). Available at: https://clinicaltrials.gov/ct2/show/NCT03057977. Last check: July 2020.
  9. GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980-2015: A systematic analysis for the Global Burden of Disease Study 2015. The Lancet. 2016; 388(10053): 1459-1544.
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