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BACKGROUND AND AIMS: Sodium-glucose co-transporter 2 inhibition reduces the risk of hospitalisation for heart failure and for death in patients with symptomatic heart failure. However, trials investigating the effects of this drug class in patients following acute myocardial infarction are lacking.
METHODS: In this academic, multicentre, double-blind trial, patients (n = 476) with acute myocardial infarction accompanied by a large creatine kinase elevation (>800 U/L) were randomly assigned to empagliflozin 10 mg or matching placebo once-daily within 72 hours of percutaneous coronary intervention. The primary outcome was the N-terminal pro-hormone of brain natriuretic peptide (NT-proBNP) change over 26 weeks. Secondary outcomes included changes in echocardiographic parameters.
RESULTS: Baseline median (interquartile range) NT-proBNP was 1,294 (757-2,246) pg/ml. NT-proBNP reduction was significantly greater in the empagliflozin group, compared with placebo, being 15% lower (95% confidence interval [CI] -4.4% to -23.6%) after adjusting for baseline NT-proBNP, sex and diabetes status (p = 0.026). Absolute left ventricular ejection fraction improvement was significantly greater (1.5%, 95% CI 0.2% to 2.9%, p = 0.029), mean E/e' reduction was 6.8% (95% CI 1.3% to 11.3%, p = 0.015) greater, and left ventricular end-systolic and end-diastolic volumes were lower by 7.5 ml (95% CI 3.4 to 11.5 ml, p = 0.0003) and 9.7 ml (95% CI 3.7 to 15.7 ml, p = 0.0015), respectively, in the empagliflozin group, compared with placebo. Seven patients were hospitalised for heart failure (three in the empagliflozin group). Other predefined serious adverse events were rare and did not differ significantly between groups.
CONCLUSIONS: In patients with a recent myocardial infarction, empagliflozin was associated with a significantly greater NT-proBNP reduction over 26 weeks, accompanied by a significant improvement in echocardiographic functional and structural parameters.
As a Internist, I find these results are a trend setter in the current clinical guidelines and may change the existing guidelines. The study model is a multicentre, double-blind trial, with adequate sample size of patients (n=476). The outcome parameters are very well defined. With no doubt, this article deserves to be in the top 3 headlines.
This is an interesting clinical trial, well designed and showing statistically significant results. However, the main and secondary outcomes are disease-oriented rather than patient-oriented, and it would be better to evaluate clinical outcomes like mortality, dyspnea scores or functional scales. I think the results of this trial are promising but not ready to implement in clinical practice in this moment.