Year : 2022 | Volume
: 8 | Issue : 2 | Page : 77--78
The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure a multinational randomized trial (The EMPULSE Trial)
Department of Cardiology, AIIMS, New Delhi, India
Department of Cardiology, AIIMS, New Delhi
The EMPULSE trial was a randomized, double-blind, intention-to-treat trial that screened 566 patients, hospitalized for acute heart failure (HF). It showed that empagliflozin is effective and safe in patients admitted as decompensated chronic HF or de novo HF irrespective of baseline ejection fraction (EF).
|How to cite this article:|
Sardar S. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure a multinational randomized trial (The EMPULSE Trial).J Pract Cardiovasc Sci 2022;8:77-78
|How to cite this URL:|
Sardar S. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure a multinational randomized trial (The EMPULSE Trial). J Pract Cardiovasc Sci [serial online] 2022 [cited 2023 Jan 31 ];8:77-78
Available from: https://www.j-pcs.org/text.asp?2022/8/2/77/354138
Acute heart failure (AHF) is one of the most common causes of hospitalization in older people and is associated with significant morbidity and mortality. Patients presenting with AHF have a mortality risk of up to 10% in hospital, and in 1-year postdischarge, the mortality can reach up to 25%–30%., There has been a paradigm shift in the management of heart failure (HF). Among many drugs that have been shown to reduce morbidity and mortality in HF patients, sodium–glucose transporter inhibitor type 2 is the new kid in the block.
The effect of SGLT2i in chronic HF is already established through trials such as Emperor Reduced, DAPA HF, and Emperor Preserved, that have shown the reduction of HF hospitalization (HFH) and cardio vascular (CV) mortality in HF with reduced ejection fraction population and reduction of HFH in HF with preserved ejection fraction population. SOLOIST-WHF trial using sotagliflozin, an SGLT1/2 inhibitor showed a decrease HFH in patients admitted due to acute decompensated HF (ADHF). However, AHF is a new domain in which SGLT2i has yet to show a benefit in the clinical trial.
The EMPULSE trial sought to elucidate the role of SGLT2i empagliflozin on mortality, HFH, and quality of life.
The study was a randomized, double-blind, parallel, intention-to-treat, multicenter study conducted from June 2020 to February 2021 at 118 centers in 15 countries. Five hundred and sixty-six AHF patients were initially screened and stratified in either empagliflozin or placebo arm. The randomization was done 1 day to 5 days after hospitalization and after initial stabilization, provided the patient has SBP >100 mmHg and no symptoms of hypotension, no increase in IV diuretic dose, no IV vasodilators within 6 h, and no IV inotropic drug usages within 24 h. NT proBNP cut off was >1600 pg/ml, BNP cut off was >400 pg/ml. Cardiogenic shock, pulmonary embolism, recent Cerebrovascular accident (CVA), Acute Myocardial infarction (AMI) within 90 days, current or expected cardiac transplant, Left ventricular assist device (LVAD), end stage renal disease (eGFR) <20, or requiring dialysis and prior ketoacidosis have been excluded from the study.
The primary outcome was assessed by the stratified win ratio, which is calculated in a hierarchical manner and defined by a composite of death, number of HF events, and change in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score from baseline to 90 days. The stratified win ratio is the number of wins in the empa group divided by the number of losses compared to placebo. Clinical benefit occurred at 53.9% in the empa group and 39.7% in the placebo group (P = 0.0054). In addition, death or first HF events and acute renal failure events were numerically lower in empa arm than in placebo. The adverse effects of empagliflozin are of similar in nature to placebo.
In spite of these merits, this trial has some limitations. First, the short enrollment window and prior patient stabilization might have excluded older, frailer, and more severe patients. Second, the use of sacubitril valsartan (ARNI) was relatively less in this trial. Third, the sample size was relatively small. Fourth, the mortality or the HF events, although numerically less did not reach to statistical significance.
Regardless, the trial succeeds in demonstrating the significant clinical benefit of empagliflozin among ADHF patients, independent of symptomatic impairment at baseline. The effect was consistent across broad spectrum of HF patients, such as acute de novo or decompensated HF and with or without diabetes mellitus.
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Conflicts of interest
There are no conflicts of interest.
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