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Novartis' Entresto Misses Primary Endpoint In Study After Heart Attacks

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  • Novartis AG (NYSE: 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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