Potential Implications of Expanded US Food and Drug Administration Labeling for Sacubitril/Valsartan in the US.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) expanded labeling for sacubitril/valsartan for use in individuals with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) lower than normal. The population-level implications of implementation of sacubitril/valsartan at higher LVEF ranges is unknown. While the Prospective Comparison of ARNI With ARB Global Outcomes in HF With Preserved Ejection Fraction (PARAGON-HF) trial did not meet its primary end point, the trial may provide useful information in projecting expected clinical events among treated individuals.

Objective

To quantify newly eligible treatment candidates for sacubitril/valsartan under the expanded FDA labeling and to apply treatment effects and the number needed to treat (NNT) to preve

SUBMITTER: Vaduganathan M 

PROVIDER: S-EPMC8444065 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature