Making the Case for an Expanded Indication for Sacubitril/valsartan in Heart Failure

On December 15, the FDA convened an advisory committee to consider whether the results of the PARAGON-HF trial, which compared sacubitril/valsartan to valsartan in patients with heart failure and LVEF of 45% or greater, warranted a new indication for sacubitril/valsartan. In presenting the results of the trial and a perspective on these results, we argued that despite narrowly missing statistical significance for its primary endpoint, the PARAGON-HF data were compelling enough to justify expansion of the current indication for sacubitril/valsartan to include patients with heart failure whose ejection fractions were less than normal but above the range currently used to define heart failure with reduced ejection fraction (i.e.

Source: Journal of Cardiac Failure - April 15, 2021 Category: Cardiology Authors: Scott D. Solomon, John J.V. McMurray Source Type: research