Novartis analyses suggest Entresto benefit beyond HFrEF

Treatment with Entresto may result in greater reductions in heart failure hospitalisations and cardiovascular death, as compared to valsartan, in specific subgroups, according to recently reported subgroup analyses from Novartis.

The new data comes from the company’s global Phase III PARAGON-HF study of patients with heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure.

This greater benefit was seen in women with HFpEF and in HFpEF patients recently hospitalised for heart failure.

In addition, in a pooled analysis of PARAGON-HF (HFpEF) and PARADIGM-HF (heart failure with reduced ejection fraction (HFrEF)), greater treatment benefit was observed in patients with left ventricular ejection fraction (LVEF) below approximately 60%.

HFpEF is a type of heart failure that has no currently approved treatment and disproportionately affects women.

Currently, Entresto (sacubitril/valsartan) is an approved and essential treatment for patients with HFrEF, which is typically defined as ejection fraction less than or equal to 40%.

This is based on its superiority to the angiotensin-converting enzyme (ACE) inhibitor enalapril in reducing cardiovascular death and heart failure hospitalizations, as demonstrated in the PARADIGM-HF trial.

“These new analyses show that the treatment benefit of sacubitril/valsartan may extend to patients with a LVEF higher than the threshold we use to define HFrEF,” said Scott Solomon, Director of Noninvasive Cardiology at Brigham and Women’s Hospital, Professor at Harvard Medical School and PARAGON-HF Executive Committee Co-Chair.

“The data help to provide a greater understanding of the heterogeneous nature of HFpEF and the potential benefit of sacubitril/valsartan for those who are still in need of a treatment option.”

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