Topline results reported from phase III PARAGON-HF study of sacubitril/valsartan in HFpEF, a form of heart failure

Novartis announced topline results from the global Phase III PARAGON-HF study investigating the safety and efficacy of sacubitril/valsartan versus the active comparator valsartan in HFpEF ( a distinct type of heart failure where the heart muscle contracts normally but the ventricles do not relax as they should during ventricular filling (or when the ventricles relax). HFpEF can be associated with high hospitalization rates, poor quality of life and increased mortality, and it is emerging as the predominant form of HF. There is currently no approved treatment for HFpEF) patients .

The trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations. Safety and tolerability were consistent with previously reported sacubitril/valsartan data.

"Around half of all heart failure patients, some 13 million people worldwide, are estimated to suffer from HFpEF, and there is currently no approved treatment. We embarked upon the landmark Phase III PARAGON-HF trial to determine whether sacubitril/valsartan could have a meaningful impact on the treatment of HFpEF, as it does in the treatment of heart failure with reduced ejection fraction," said John McMurray, M.D., Professor of Medical Cardiology at University of Glasgow and PARAGON-HF Executive Committee Co-Chair.

Sacubitril/valsartan (approved as Entresto since 2015) is a first-choice treatment in heart failure with reduced ejection fraction (HFrEF), based on its superiority to the angiotensin-converting enzyme (ACE) inhibitor enalapril and its ability to significantly reduce CV death and HFrEF hospitalizations . Novartis continues to study sacubitril/valsartan in HFrEF, with new data on cardiac remodeling being presented at the ESC Congress 2019. Detailed PARAGON-HF results will also be reported at that time. Additional studies investigating sacubitril/valsartan on other relevant endpoints in HFpEF are ongoing.