Phase III ODYSSEY OUTCOMES trial of Praluent shows fewer deaths from CV events-. Sanofi + Regeneron.

New analyses on mortality from the 18,924-patient phase III ODYSSEY OUTCOMES trial of Praluent (alirocumab), from Regeneron, shows it is associated with fewer deaths from any cause among patients who had previously experienced a heart attack or unstable angina (known as acute coronary syndrome, or ACS), and this was enhanced in patients who were followed for at least 3 years and those who had an LDL-C (low-density lipoprotein cholesterol) of 100 mg/dL or higher at baseline. Moreover, additional new analyses showed an association between reduced non-fatal cardiovascular (CV) events and reduction in non-CV death during the trial period. In the trial, Praluent added to maximally-tolerated statins was compared to maximally-tolerated statins alone in patients who had experienced an ACS within the last 12 months.

Data published in The New England Journal of Medicine last week found Praluent significantly reduced the risk of major adverse cardiovascular events (MACE) and was associated with a lower risk of death from any cause. In pre-specified analyses of 8,242 patients followed for at least 3 years, Praluent was associated with a 22% lower risk of death from any cause. Separate post-hoc analyses showed Praluent-treated patients whose baseline LDL-C levels were at or above 100 mg/dL experienced a 29% lower risk of death from any cause.

In additional post-hoc analyses researchers found Praluent-treated patients experienced fewer non-fatal CV events and were less likely to die from a non-CV event and that these two findings may be associated (association between non-fatal and fatal events = 2.35). No new safety signals were found in the analyses. In ODYSSEY OUTCOMES, the incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the Praluent group vs. 2.1% in the placebo group). Data were presented at the American Heart Association (AHA) Scientific Sessions 2018.