PARIS and TARRYTOWN, N.Y., Nov. 7, 2018 /PRNewswire/ -- 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) Injection 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).1
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.
Praluent is approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union (EU). In the U.S., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
Important Safety Information for the U.S.
Do not use Praluent if you are allergic to alirocumab or to any of the ingredients in Praluent.
Before you start using Praluent, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.
Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.
Praluent can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
The most common side effects of Praluent include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Talk to your doctor about the right way to prepare and give yourself a Praluent injection and follow the "Instructions for Use" that comes with Praluent.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists for 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, including VelocImmune® to yield optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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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.
Analyses 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.