Novartis announced topline results from the phase 3 PARAGON-HF study evaluating the safety and efficacy of sacubitril/valsartan (Entresto) in heart failure patients with preserved ejection fraction (HFpEF).
The multicenter, double-blind, parallel group, active-controlled study compared sacubitril/valsartan to valsartan in reducing cardiovascular (CV) death and heart failure (HF) hospitalizations in HFpEF for up to 57 months. Patients (N=4822) were randomized to receive a target dose of sacubitril/valsartan 97mg/103mg or valsartan 160mg twice a day after meeting the safety criteria from a single blind run-in period of 3-8 weeks. The primary end point was the composite of CV death and total (first and recurrent) HF hospitalizations.
Results showed that the trial missed statistical significance for its composite primary end point. However, the safety and tolerability of sacubitril/valsartan remained consistent with previously reported data.
Full detailed results will be presented at the European Society of Cardiology (ESC) Congress 2019, along with new data on cardiac remodeling in HF patients with reduced ejection fraction (HFrEF). The Company is currently investigating sacubitril/valsartan in additional studies for HFpEF.
“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, MD, Global Drug Development and Chief Medical Officer, Novartis.
Entresto is a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker and is indicated for use as first-line treatment to reduce the risk of CV death and hospitalization for HF in patients with chronic HF (NYHA Class II-IV) and reduced ejection fraction.
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