Update on Novartis’ Phase III PARAGON-HF trial in heart failure patients with preserved ejection fraction (HFpEF)

Novartis today 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 patients. The trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations[1]. 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.

“We look forward to presenting and discussing the data from PARAGON-HF, which should inform our understanding and treatment of HFpEF, at the ESC Congress 2019,” said Scott Solomon, M.D., Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and PARAGON-HF Executive Committee Co-Chair.

“The totality of evidence from the trial suggests that treatment with sacubitril/valsartan may result in clinically important benefits in HFpEF. We will be discussing potential next steps with clinical experts and regulators while we prepare to present the full results at the ESC Congress 2019 in September,” said John Tsai, M.D., Global Drug Development and Chief Medical Officer, Novartis, “We thank the patients, investigators and site personnel around the world for their support during the PARAGON-HF study.”

There is currently no approved treatment for HFpEF. 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.

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