Updated FDA Policy Could Improve Treatment For Up To 1.8 Million HF Patients

"On Feb.16, 2021, the FDA expanded regulatory labeling for sacubitril/valsartan to reduce the risk of cardiovascular death and hospitalization for HF in adult patients with chronic HF," explained lead author Muthiah Vaduganathan, MD, MPH, with the division of cardiovascular medicine at Brigham and Women’s Hospital and Harvard Medical School, and colleagues. "These regulatory changes were based on data from the PARAGON-HF trial (which enrolled participants with HF and left ventricular ejection fraction [LVEF] of 45% or greater), contextualized alongside data from the PARADIGM-HF trial (which enrolled participants with HF and LVEF of 40% or less)."

The study's authors hoped to learn more about the potential long-term impact of this regulatory change, focusing on data from the National Health and Nutrition Examination Survey from 2015 to 2018. Their primary aim was to measure the number of worsening HF events prevented or postponed if eligible patients were treated with sacubitril/valsartan for three years. Researchers analyzed 4,682,098 newly eligible adult patients with HF. Forty-two percent of patients were women, and the mean patient age was 66.3 years old.

Overall, the number of patients likely to be newly eligible varied by the definition of FDA labeling of lower-than-normal LVEF. That number was 643,161 participants if lower-than-normal LVEF was defined as 41% to 50%, and it was 1,838,756 participants if lower-than-normal LVEF was defined as 41% to 60%.

According to the authors, comprehensive implementation of sacubitril/valsartan in patients could potentially prevent up to 69,268 worsening HF events (if lower-than-normal LVEF is defined as 41% to 50%) or up to 182,592 worsening HF events (if lower-than-normal LVEF is defined as 41% to 60%) over three years of treatment.

“These data support a favorable risk-benefit margin for most newly eligible treatment candidates,” the authors wrote. “Additionally, even patients who experience hypotension with initial drug exposure may derive subsequent clinical benefit, as has been previously shown in the PARADIGM-HF trial.”