NEJM publishes positive results from Praluent cardiovascular outcomes trial.- Sanofi + Regeneron

The New England Journal of Medicine (NEJM) published positive detailed results of the 18,924-patient ODYSSEY OUTCOMES trial.The trial met its primary endpoint, showing that Praluent (alirocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered an acute coronary syndrome (ACS), which included a heart attack or unstable angina.

The trial met its primary endpoint, showing that Praluent� (alirocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered an acute coronary syndrome (ACS), which included a heart attack or unstable angina. MACE occurred in 903 patients (9.5%) in the Praluent group and in 1,052 patients (11.1%) in the placebo group (HR 0.85; 95% CI, 0.78 to 0.93; p<0.001). death from any cause was less frequent among praluent-treated patients. praluent was associated with a 15 lower risk of death death occurred in 334 3.5 patients in the praluent group and 392 4.1 patients in the placebo group hr 0.85 95 ci 0.73 to 0.98.>

The NEJM publication also includes results for MACE and other secondary endpoints including death, according to subgroups of baseline LDL-C (low-density lipoprotein cholesterol) levels, which are described in detail in the Supplementary Appendix. The data showed that patients with higher LDL-C at baseline (at least 100 mg/dL) were at greater risk of MACE, as well as other secondary endpoints including death. Moreover, the greater risk-reduction occurred in this category of patients: in the Praluent group MACE was reduced by 24% (HR 0.76; 95% CI, 0.65 to 0.87) and death from any cause was 29% lower (HR 0.71; 95% CI, 0.56 to 0.90) compared to placebo.

See- "Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome" -Gregory G. Schwartz, M.D., Ph.D., P. Gabriel Steg, M.D., Michael Szarek, Ph.D., Deepak L. Bhatt, M.D., M.P.H., Vera A. Bittner, M.D., M.S.P.H., Rafael Diaz, M.D., Jay M. Edelberg, M.D., Ph.D., et al.,November 7, 2018 DOI: 10.1056/NEJMoa1801174.