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The FDA recently approved expanded indication for sacubitril/valsartan (Entresto) making it the first therapy approved Heart Failure with Preserved Ejection Fraction (HFpEF), which comprises about half of total cases of Heart Failure in the US. The expanded indication is primarily based on data from the PARAGON-HF trial, for patients with a left ventricular ejection fraction above 40% but below 57%, with benefit for hospitalization for heart failure and CV mortality.
This expanded approval now includes patients who were previously ineligible because their ejection fraction was above the level considered reduced (>40%), but less than normal (< 60%).
It is conceivable that there is some overlap in pathophysiology between patients with LVEF < 40% and LVEF<57%, as evaluated in PARADIGM and PARAGON-HF trials.
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