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A novel approach to heart failure with preserved ejection fraction (HFpEF) that takes a page from fibrotic lung disease appeared to pay off, with a reduction in myocardial fibrosis, the phase II PIROUETTE trial showed.
The antifibrotic drug pirfenidone (Esbriet, approved for idiopathic pulmonary fibrosis) reduced myocardial extracellular volume by 1.21 percentage points more than placebo over 52 weeks (0.7% decline vs 0.5% increase,
P=0.009).
A treatment effect of that magnitude would be expected to translate to a 9% to 28% reduction in heart failure hospitalization or death, based on recent observational studies, reported Christopher Miller, MBChB, PhD, of the University of Manchester in England, at the virtual American College of Cardiology (ACC) meeting.
May 15, 2021
For immediate post-MI patients, sacubitril/valsartan (Entresto; Novartis) does not significantly decrease the risk of heart failure (HF) or CV death compared with an ACE inhibitor, the PARADISE-MI trial shows.
sacubitril/valsartan is superior to an ACE inhibitor in patients who have symptomatic HF with reduced ejection fraction when it comes to reducing both HF events and total mortality, PARADISE-MI fell short by missing its primary endpoint of a 15% reduction in events needed to demonstrate superiority of the angiotensin receptor neprilysin inhibitor (ARNI) over an ACE inhibitor, ramipril, in this acute MI population. Nevertheless, there was a 10% reduction in the sacubitril/valsartan group and positive reports of reduced events from investigators who participated in the large multinational trial.
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Sacubitril/valsartan (Entresto) became the first drug to get a broad heart failure indication that reaches into the normal ejection fraction range for prevention of cardiovascular death and hospitalization, Novartis announced.
FDA granted the drug an expanded indication to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
An advisory committee weighing approval in December voted unanimously in favor of expanding the angiotensin receptor–neprilysin inhibitor s indication beyond that in heart failure with reduced ejection fraction (HFrEF) based on the PARAGON-HF trial.