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November 13, 2018

Novartis reports positive results from PIONEER-HF trial

Novartis Pharmaceuticals has reported positive results from the PIONEER-HF trial of entresto for the treatment of heart failure with reduced ejection fraction (HFrEF) patients who had been admitted for acute decompensation heart failure (ADHF) event.

Novartis Pharmaceuticals has reported positive results from the PIONEER-HF trial of entresto for the treatment of heart failure with reduced ejection fraction (HFrEF) patients who had been admitted for acute decompensation heart failure (ADHF) event.

The study investigated the safety, tolerability, and efficacy of in-hospital initiation of entrestoin in comparison with enalapril.

The primary objective of the trial was met when patients treated with entresto demonstrated a 29% reduction in time-averaged N-terminal pro-B-type natriuretic peptide (NT-proBNP) at weeks four and eight compared to patients treated with enalapril.

It was found that the superiority of entresto over enalapril was consistent in reducing NT-proBNP across the HFrEF patient groups who were stabilised following admission for ADHF. The numbers of serious adverse events were found to be similar in both groups.

“PIONEER-HF further confirmed the safety and benefit, as reflected in the reduction of an important biomarker, of in-hospital initiation of entresto treatment.”

Novartis’ pre-specified exploratory analysis showed that the composite endpoint of death, re-hospitalisation for heart failure, left ventricular assist device (LVAD) implantation or listing for cardiac transplant occurred in 9.3% of patients treated with entresto and 16.8% in the enalapril group.

Novartis Pharmaceuticals chief medical officer Shreeram Aradhye said: “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.”

PIONEER-HF is a prospective, multi-centre, double-blind, controlled trial that enrolled 881 patients.

Patients were randomly assigned to received a twice-daily dose of entresto or enalapril.

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