First results with ARNI in large CV outcome trial in HFpEF
Results from the phase III PARAGON-HF trial were announced on efficacy and safety of sacubitril/valsartan vs. the active comparator valsartan in HFpEF patients. Statistical significance was just missed for the composite endpoint of CV death and total HF hospitalizations. Safety and tolerability were consistent with previous data.
John Tsai, MD, Global Drug Development and Chief Medical Officer at Novartis, said: "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".
Sacubitril/valsartan was superior to enalapril in HFrEF with respect to reducing CV death and HF hospitalizations, and has been recommended as therapy in HFrEF patients. Up to now, there is no approved treatment for HFpEF.
PARAGON-HF is a phase III, randomized, double-blind, parallel group, active-controlled, 2-arm, event-driven trial that compared long-term efficacy and safety of sacubitril/valsartan vs. valsartan alone in 4822 HFpEF patients. Patients in the study represented ambulatory patients with established HFpEF, half of them had a history of HF hospitalizations. Primary outcome was the composite of total (first and recurrent) HF hospitalizations and CV death. PARAGON-HF is part of FortiHFy, a large global clinical program in HF, consisting of more than 40 clinical studies to generate data on symptom reduction, efficacy, quality of life benefits and real world evidence with sacubitril/valsartan.
PARAGON-HF was preceded by the phase II PARAMOUNT-HF trial that demonstrated reduced NT-proBNP levels with sacubitril/valsartan in HFpEF patients at 12 weeks and improvement of NYHA class at 36 weeks compared to valsartan.