Researchers were astounded to find that in patients with advanced heart failure (HF), the angiotensin-receptor neprilysin inhibitor (ARNI) sacubitril/valsartan was not superior to valsartan for efficacy, tolerability, or safety in the LIFE trial.
Compared with patients who received valsartan, those who received sacubitril/valsartan did not have a significantly lower area under the curve (AUC) for change in levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline through 24 weeks, a surrogate for reverse cardiac remodeling and the primary study endpoint.
“We were surprised and disappointed and stared at the data for a long time, partly in disbelief,” said Douglas L. Mann, MD, during a Late-Breaking Clinical Trial session at the virtual American College of Cardiology 2021 Scientific Session.
Nevertheless, “we know a lot more now about the safety and tolerability and efficacy for this remarkable class of drugs,” said Mann, Lewin Distinguished Professor of Cardiovascular Disease, Washington University, St. Louis.