Novartis' Entresto Misses Primary Endpoint In Study After Heart Attacks

Novartis AG NVS revealed details on Phase 3 PARADISE-MI trial evaluating Entresto (sacubitril/valsartan) compared with ramipril in a contemporary acute myocardial infarction (AMI) population.
Data were presented at the American College of Cardiology's virtual Scientific Session.
In the Q1 earnings release, Novartis reported that Entresto missed its primary endpoint to reduce the risk of cardiovascular death and heart failure after acute myocardial infarction.
In the 5,669-patient Paradise-MI trial, heart attack patients on Entresto were 10% less likely than those on ramipril to be hospitalized for heart failure, die of cardiovascular causes, or develop symptomatic heart failure. The drug needed to hit 15% for the win to be statistically significant.
In the Paradise-MI trial, symptomatic heart failure diagnosis or hospitalization, or death from cardiovascular causes, cropped up in Entresto patients at a rate of 6.7 per 100 patient-years, or 11.9%.
Ramipril charted a 13.2% event rate or 7.4 per 100 patient-years.
An exploratory analysis of the total burden of heart failure, which included recurrent events, showed a 21% reduction in patients on Entresto versus ramipril.
The rate of cardiovascular death for Entresto patients was 5.9% versus ramipril's 6.7%.
There was a 6% rate of heart failure hospitalizations in the Entresto arm, versus 6.9% in the ACE inhibitor cohort.
1.4% of Entresto patients developed outpatient heart failure compared to 2% in subjects who received ramipril.
See the AAC.21 presentation here.
Price Action: NVS shares are up 0.04% at $89 during the market session on the last check Monday.

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