New England Journal of Medicine publishes positive detailed results from Praluent® (alirocumab) cardiovascular outcomes trial
PARIS AND Tarrytown, N.Y. - November 7, 2018 - The New England Journal of Medicine (NEJM) today 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. 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 placebo2.
Adverse events were similar between groups except for injection site reactions (Praluent 3.8%, placebo 2.1%).
Results of the ODYSSEY OUTCOMES trial were presented at the American College of Cardiology's 67th Annual Scientific Session & Expo in March 2018. Additional analyses, including mortality, will be presented later this week at the American Heart Association Scientific Sessions 2018.
"Despite the use of statins, many patients with coronary heart disease go on to have recurrent cardiovascular events, underscoring the need for additional treatment options. This need is particularly urgent among patients with acute coronary syndrome and LDL-C levels that remain high despite best possible application of statin therapy," said Dr. Gregory G. Schwartz, M.D., Ph.D., University of Colorado School of Medicine, Aurora, CO, and co-chair of the trial. "These data in the New England Journal of Medicine show that adding alirocumab to intensive or maximum tolerated statin treatment significantly reduced the risk of future cardiovascular events. This benefit was heightened among study patients with higher LDL-C levels at baseline."
The effect of Praluent on cardiovascular morbidity and mortality is currently being reviewed by regulatory authorities and has not yet been fully evaluated. Data from the ODYSSEY OUTCOMES trial has been submitted to regulatory authorities in the European Union and in the U.S., where the target action date for the Food and Drug Administration (FDA) decision is April 28, 2019.
Click here for additional information on the ODYSSEY OUTCOMES trial and Praluent.
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Analyses for the death endpoints in the overall study fell outside of the statistical hierarchy; and in accordance with recently implemented NEJM policies, the hazard ratio (HR) and its confidence interval (CI) were published, but no P-values were reported.
2Analyses of the death endpoint based on baseline LDL-C levels were not included in the statistical hierarchy; and in accordance with recently implemented NEJM policies, the hazard ratio (HR) and its confidence interval (CI) were published, but no P-values were reported.
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