Entresto has a moderate clinical benefit compared to Ramipril after an acute MI

Entresto versus Ramipril: Clinical Benefits

At the 2021 70th Annual Meeting of the American College of Cardiology (ACC), results were presented from the PARADISE-MI trial, which investigated whether Entresto (sacubitril/valstartan) reduces the risk of heart failure (HF) or cardiovascular (CV) death compared with an angiotensin-converting enzyme (ACE) inhibitor, Ramipril, in the increased risk of acute myocardial infarction (AMI) population. Evidence from previous trials had shown that Entresto was superior to the ACE inhibitor, Ramipril, for patients with symptomatic HF with reduced ejection fraction (HFrEF), in terms of reducing HF events and all-cause mortality. PARADISE-MI missed the primary endpoint of a 15% reduction in HF events needed to demonstrate superiority of Entresto, the first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) over Ramipril, in the AMI participant population. However, overall there was an observed reduction of 10% (p=0.17) in the Entresto group and positive reports of reduced HF events by trial investigators. Based on these results, it remains to be seen whether physicians are likely to prescribe the drug to a broader patient group and whether the incremental benefit has real clinical value to drive the already low uptake of Entresto. GlobalData predicts that Novartis’ Entresto, currently approved for the chronic HF market, is likely to remain at its current low uptake among physicians due to the lack of significant clinical data demonstrating broader potential application of the drug in the AMI population. Furthermore, the superiority of the established ACE inhibitor for the treatment of chronic HF patients is likely to remain, as Entresto’s uptake has had pricing and access issues, coupled with a modest clinical benefit over the much cheaper standard of care of ACE inhibitors and clinical trial failures all of which have created doubts among prescribers.

PARADISE-MI enrolled 5,669 participants from 41 countries who had previously experienced an AMI within the past 7 days (mean 4.3 days). None of these patients had a history of HF, but all had transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40% and at least one additional risk factor for HF or death from age ≥70 years, estimated glomerular filtration rate

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“Entresto has a moderate clinical benefit compared with Ramipril after an acute MI” was originally created and published by Clinical Trials Arena, a brand of GlobalData.

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