Novartis managed to get Entresto approved in patients with heart failure with preserved ejection fraction despite the failure of the Paragon trial. But it looks unlikely to be able to repeat the trick in post-myocardial infarction patients, full results from the Paradise MI trial suggest. The study, presented at the American College of Cardiology meeting today, found a 10% relative risk reduction in its primary endpoint, a composite of cardiovascular death, first heart failure hospitalisation or outpatient heart failure, with Entresto versus the angiotensin-converting enzyme ramipril. This was well below the 15% target. However, the lead investigator, Dr Marc Pfeffer of the Brigham and Women's Hospital, still seems to believe that there could be a path forward for Entresto in this pre-heart failure population. He highlighted a secondary endpoint, time to both first and recurrent events, where Entresto showed a bigger benefit – however, given the primary endpoint miss, this can only be considered exploratory. When asked whether this might convince regulators, he said that “remains to be seen. I’d like to pursue that. But that’s going to be a question for the sponsor.” Over to Novartis, though this looks like a lost cause even by the company’s standards.
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