L'etude clinique du mois. PARAGON-HF : sacubitril/valsartan (Entresto(R)) dans l'insuffisance cardiaque a fraction d'ejection preservee (HFpEF).

The <<Prospective Comparison of ARNI with ARB Global Outcomes in HF with Preserved Ejection Fraction>> (PARAGON HF) trial is a multicenter, randomized, double-blind study comparing the incidence of heart failure hospitalization and cardiovascular mortality in patients with heart failure with preserved ejection fraction (HFpEF) treated with sacubitril/valsartan (Entresto(R)) versus valsartan alone. After a median follow-up of 35 months, the primary endpoint was reduced by 13 % in the sacubitril/valsartan group compared to the valsartan group (relative risk: 0.87, 95 % IC: 0.753-1.005, p = 0.058). Despite this lack of significance, the incidence of hospitalizations for heart failure was reduced (RR 0.85, 95 % CI: 0.72-1.00), whereas no benefit was observed on cardiovascular mortality. A subgroup analysis suggested that women and patients with an intermediate ejection fraction could get more benefit from the treatment. Concerning secondary criteria, a significant improvement in quality of life and in heart failure symptoms was observed in the group sacubitril/valsartan. There was a greater incidence of arterial hypotension and angioneurotic edema, but a lower incidence of hyperkalemia in the group sacubitril/valsartan.