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Heart failure (HF) is a progressive and serious condition, affecting approximately 26 million people worldwide, where the heart cannot pump enough blood to the body. Additional studies investigating sacubitril/valsartan on other relevant endpoints in HFpEF are ongoing.
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PARAGON-HF follows the only positive Phase II trial in HFpEF, PARAMOUNT-HF, which demonstrated that sacubitril/valsartan reduced NT-proBNP (a biomarker of cardiac strain) to a greater extent than valsartan at 12 weeks and was associated with improvement in NYHA class at 36 weeks. Established by Novartis, the FortiHFy program comprises more than 40 active or planned clinical studies designed to generate an array of additional data on symptom reduction, efficacy, quality of life benefits and real world evidence with sacubitril/valsartan, as well as to extend understanding of heart failure. PARAGON-HF is part of FortiHFy, the largest global clinical program in the heart failure disease area across the pharmaceutical industry to date. The primary endpoint of the trial is the composite of total (first and recurrent) heart failure hospitalizations and cardiovascular death. The patients in the study represented ambulatory patients with established HFpEF being treated for symptoms and comorbidities, approximately half of whom had a history of heart failure hospitalizations. The Phase III randomized, double-blind, parallel group, active-controlled, 2-arm, event-driven trial compared the long-term efficacy and safety of sacubitril/valsartan versus valsartan in 4,822 patients with HFpEF. PARAGON-HF is the largest clinical trial in heart failure with preserved ejection fraction (HFpEF) conducted to date. Detailed PARAGON-HF results will also be reported at that time. Novartis continues to study sacubitril/valsartan in HFrEF, with new data on cardiac remodeling being presented at the ESC Congress 2019. 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.
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There is currently no approved treatment for HFpEF.
#Paragon trial entresto full#
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.” “The totality of evidence from the trial suggests that treatment with sacubitril/valsartan may result in clinically important benefits in HFpEF. “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. 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. “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. Safety and tolerability were consistent with previously reported sacubitril/valsartan data. The trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations.
#Paragon trial entresto update#
Novartis provides update on Phase III PARAGON-HF trial in heart failure patients with preserved ejection fraction (HFpEF)