pharmatimesNovember 14, 2018
Tag: Novartis , AHA , NT-proBNP
Novartis has declared new findings for Entresto (sacubitril/valsartan) at the American Heart Association's (AHA) scientific sessions, showing that the drug proved itself superior to enalapril-a in patients with heart failure with reduced ejection fraction (HFrEF) who had been stabilised following hospitalisation for an acute decompensation heart failure (ADHF) event.
Data derived from 881 participants with an average age of 61 showed that Entresto use led to a 29% greater reduction in time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) – an established biomarker for heart failure prognosis – after four and eight weeks of treatment compared to enalapril, meeting the trial’s primary endpoint. This reduction was shown to be consistent across HFrEF patient populations, including African American patients, the newly diagnosed, and those not receiving an ACEi/ARB treatment.
Additionally, the drug reduced the risk of a composite of death, heart failure re-hospitalisation, the need for a left ventricular assist device, or listing for cardiac transplantation over eight weeks compared to enalapril.
"The results of this landmark study should help inform our basic approach to treating hospitalised patients with acute heart failure," explained Dr Eric Velazquez, Berliner Professor of Cardiology at Yale School of Medicine and principal study investigator on the PIONEER-HF from which the data was drawn. "With the PIONEER-HF trial results-once acute heart failure is diagnosed, patients are hemodynamically stabilised, and a low ejection fraction is confirmed-sacubitril/valsartan should be started promptly to reduce neurohormonal activation and reduce the risk of post-discharge heart failure hospitalisation."
Also commenting on the results, Dr Shreeram Aradhye, Chief Medical Officer and Global Head, Medical Affairs at Novartis, remarked: "PIONEER-HF further confirmed the safety and benefit, as reflected in the reduction of an important biomarker, of in-hospital initiation of Entresto treatment in HFrEF patients stabilised following ADHF. Together with data from the PARADIGM-HF study, which demonstrated the superior benefit of Entresto compared to an ACEi on cardiovascular mortality and HF hospitalisations in ambulatory patients, there is now consistent evidence in the in and outpatient settings supporting the use of Entresto. Through the Entresto scientific programme, we are reimagining the standard of care for HFrEF patients and the use of Entresto as foundation therapy."
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