Novartis said Thursday that it has presented the results of its PIONEER-HF trial for Entresto, a chronic heart failure (HFrEF) treatment, at the American Heart Association's Scientific Sessions 2018.
The results showed that the company’s drug provided superior benefit compared to enalapril-a, a heart failure medication commonly used in patients with HFrEF, in treating patients who had been stabilized following admission for an acute decompensation heart failure (ADHF) event.
An Entresto patient group had a 29 percent greater reduction in the time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) at the fourth and eighth week compared to enalapril patients. The company saw significant decreases in NT-proBNP in Entresto patients as early as the first week after treatment started.
Novartis also confirmed similar results in patients who were diagnosed with heart failure after hospitalization with acute heart failure, patients without ACEi / ARB treatment, and African Americans.
In a pre-specified exploratory analysis of PIONEER-HF, Entresto also showed a significant 46 percent reduction in the risk of a composite of death, heart failure re-hospitalization, the need for left ventricular assist device (LVAD) insertion or listing for cardiac transplantation compared to enalapril over the eight-week treatment period.
"The results of this landmark study should help inform our basic approach to treating hospitalized patients with acute heart failure," said Professor Eric Velazquez from the Yale School of Medicine and PIONEER-HF’s principal study investigator. "Once acute heart failure is diagnosed, patients are hemodynamically stabilized and a low ejection fraction is confirmed, Entresto should be started promptly to reduce neurohormonal activation and reduce the risk of post-discharge heart failure hospitalization."
Novartis Pharmaceuticals chief medical officer Shreeram Aradhye also said. “PIONEER-HF further confirmed the safety and benefit, as reflected in the reduction of a vital biomarker, of in-hospital initiation of Entresto treatment in HFrEF patients stabilized following ADHF.
Together with data from the PARADIGM-HF study, which demonstrated the superior benefit of Entresto compared to an ACE inhibitor (ACEi) on cardiovascular mortality and HF hospitalizations in ambulatory patients, now there is consistent evidence in the in-and-outpatient settings supporting the use of Entresto, Aradhye added.
The results of the study were also published in the New England Journal of Medicine.