FDA approves Empagliflozin for heart failure despite contrary results

Trials are being conducted to prevent cardiac death, The US Food and Drug Administration (FDA) has approved an expanded heart failure (HF) indication for the SGLT2 inhibitor empagliflozin that now includes heart failure with mid-range or preserved left-ventricular ejection fraction despite several results not in favour of the drug. FDA used a cautionary language in using these drugs for treatment of heart failure.

Several trials like EMPEROR PRESERVED Trial, widely anticipated the use of Empagliflozin based on the landmark results of the trial and saw a significant 21% relative reduction of occurrence of heart failure. Similarly another trial PARAGON- HF Trial evaluated sacubitril/valsartan drug, it enrolled patients with Heart Failure and Left Ventricular Ejection Fraction. The trial was "negative" in that it saw no significant advantage to the drug for its primary clinical outcome.