Mixed results for Novartis' Entresto presented at ESC

The full results from the global Phase III PARAGON-HF study, investigating the efficacy and safety of Entresto (sacubitril/valsartan) versus the active comparator valsartan in heart failure patients with preserved ejection fraction (HFpEF), showed the drug reduced the composite primary endpoint of total (first and recurrent) heart failure hospitalizations and cardiovascular (CV) death by 13% (p = 0.059).

Drug developer Novartis (NOVN: VX) said the result was primarily driven by a nearly 15% reduction (p = 0.056) in total heart failure hospitalizations (first and recurrent), but narrowly missed the primary endpoint of the study.

The full body of evidence from the trial suggests that treatment with Entresto may result in clinically important benefits in HFpEF, a heterogeneous type of heart failure with no approved treatment, in particular subgroups. Pre-specified subgroup analyses suggest even greater effects in individuals with a left ventricular ejection fraction equal to or below the median of 57% (22% reduction in primary endpoint; 95% CI: 0.641, 0.949) and in women (27.5% reduction in primary endpoint; 95% CI: 0.588, 0.895). Safety and tolerability were consistent with previously reported findings in HFrEF patients.