PIONEER-HF trial of Entresto for heart failure published in NEJM.- Novartis.
Novartis announced results of the landmark PIONEER-HF trial showing that in-hospital initiation of Entresto (sacubitril/valsartan) tablets provided superior benefit compared to enalapril - a heart failure medication commonly used-in patients with heart failure with reduced ejection fraction (HFrEF) who had been stabilized following admission for an acute decompensation heart failure (ADHF) event. Patients on Entresto in PIONEER-HF had a 29% greater reduction in time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) at weeks 4 and 8 (the primary endpoint) compared to enalapril patients.
Significant reductions in NT-proBNP were observed in Entresto patients as early as 1 week after treatment initiation. NT-proBNP is an established biomarker used to assess the severity and determine the prognosis of heart failure. Notably, the superior NT-proBNP reduction with Entresto was consistent across diverse HFrEF patient populations stabilized following admission for ADHF, including those newly diagnosed with HFrEF, those not receiving an ACEi/ARB treatment and African Americans. In a pre-specified exploratory analysis of PIONEER-HF, Entresto also showed a significant 46% reduction in the risk of a composite of death, heart failure re-hospitalization (hospital stay more than 24 hours), requirement for left ventricular assist device (LVAD) insertion or listing for cardiac transplantation compared to enalapril over 8 weeks. This result was driven primarily by reductions in death and HF re-hospitalization among patients treated with Entresto.
There were no new safety signals identified. Entresto is indicated to reduce the risk of CV death or HF hospitalization in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. Results were presented as a late-breaker at the American Heart Association's Scientific Sessions 2018 and published in The New England Journal of Medicine.
See: "Angiotensin-Neprilysin Inhibition in Acute Decompensated Heart Failure." Velazquez E et al., N Engl J Med. 2018. doi: 10.1056/NEJMoa1812851.
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