Novartis has released new analysis showing that Entresto cut cardiovascular death or hospitalisation for heart failure, “consistently benefitting” patients with reduced ejection fraction regardless of clinical stability or background therapy.

The firm said its analysis - of data from PARADIGM-HF, the largest clinical trial ever conducted in heart failure which compared Entresto (sacubitril/valsartan) to ACE inhibitor enalapril - found that the therapy was of benefit to patients considered clinically stable just as much as it did those who were least-stable.

“In PARADIGM-HF, about half of primary events among stable patients were cardiovascular death. This indicates that the full spectrum of patient types we studied in the trial may be at risk for adverse outcomes due to the disease,” noted Scott Solomon, director of noninvasive cardiology, Brigham and Women’s Hospital and Professor of Medicine, Harvard Medical School. “In fact, the analyses make a case that patients we consider clinically stable, as well as those who are already being treated with guideline-directed background therapy may benefit from sacubitril/valsartan”.

The data show that even patients considered to be clinically stable were still at risk for a serious clinical event, with 20 percent experiencing a primary endpoint event, 51 percent of which suffered CV death as their first event. According to the analysis, all patients taking Entresto experiencing a 20% or greater reduction in CV death or heart failure hospitalisation compared to those taking enalapril. This finding is particularly pertinent, given that a patient’s clinical stability often influences treatment and management decisions. 

A second analysis also showed that Novartis’ drug showed consistent benefits among patients with heart failure and reduced ejection fraction, cutting the risk of CV death or heart failure hospitalisation by around 20% compared to enalapril, regardless of background therapy.

“We’re encouraged by these new analyses for Entresto. The positive results add to the already robust evidence that shows the potential benefits this medicine can offer heart failure patients with reduced ejection fraction,” said Christi Shaw, US country head, president of Novartis Corporation and Novartis Pharmaceuticals Corporation. “What’s important is that these data can translate into real-world impact by giving doctors, nurses and other healthcare providers a much needed medicine to help more of their patients better manage this debilitating and life-threatening condition.”

Heart failure impacts nearly six million Americans, and around half have heart failure with reduced ejection fraction. The economic burden of the condition is huge, with its direct and indirect costs to the US currently exceeding $30 billion.