March 13, 2019
- Sub-analyses from ODYSSEY OUTCOMES trial, including featured clinical research, provide new Praluent insights
Four new sub-analyses from the Praluent® (alirocumab) ODYSSEY OUTCOMES cardiovascular (CV) outcomes trial will be presented at the American College of Cardiology’s 68th Annual Scientific Session (ACC.19), held March 16-18, in New Orleans, LA.
The sub-analyses from the 18,924-patient ODYSSEY OUTCOMES trial include:
- A Featured Clinical Research presentation that evaluates the impact of lowering lipoprotein(a) [Lp(a)] with Praluent on total CV events, independent of low-density lipoprotein cholesterol (LDL-C) reduction. Elevated Lp(a), an inherited lipid disorder, is associated with increased risk of atherosclerosis and CV disease.
- An oral presentation that shows Praluent treatment was associated with larger reductions in the risk of major adverse CV events and death in patients with polyvascular disease, compared to those without. Polyvascular disease is defined as having an acute coronary syndrome (ACS), plus either concurrent peripheral artery disease or cerebrovascular disease, or both.
Sanofi and Regeneron presentations at ACC.19 from the ODYSSEY clinical trial program and other trials include the following three oral presentations and five poster presentations:
Praluent Featured Clinical Research Session III
- Lipoprotein(a) Lowering by Alirocumab Contributes to Total Events Reduction Independent of Low-Density Lipoprotein Cholesterol in the ODYSSEY OUTCOMES Trial (Vera A. Bittner)
Monday, March 18, 2:30-2:40 PM CT
Other Praluent Oral Presentations
- Post-Acute Coronary Syndrome Patients with Polyvascular Disease Derive Large Absolute Benefit from Alirocumab: ODYSSEY OUTCOMES (J. Wouter Jukema)
Sunday, March 17, 8:12-8:22 AM CT - Reduction of Type 1 and Type 2 Myocardial Infarctions in Patients Treated with Alirocumab: Insights from the ODYSSEY Trial (Harvey D. White)
Monday, March 18, 8:51-9:01 AM CT
Praluent Poster Presentations
- Patients with Acute Coronary Syndrome, Elevated Atherogenic Lipoproteins, and Prior Coronary Artery Bypass Grafting Derive Large Absolute Benefit from Alirocumab: Insights from the ODYSSEY OUTCOMES Trial (Shaun G. Goodman)
Monday, March 18, 10:15-10:25 AM CT
Additional Analyses of Interest
- Statin Therapy in Patients with Cerebrovascular Disease vs. Coronary Artery Disease: Insights from the PALM Registry (Ying Xian)
Saturday, March 16, 10:00-10:45 AM CT - Long-term Residual Risk and Predictors of Cardiovascular Disease in Individuals Taking Statins for Primary Prevention: Insights from the Cartagene Study (Maxime Robert-Halabi)
Saturday, March 16, 3:45-4:30 PM CT - Practice-Level Variation in Statin Use and LDL-C Control in the United States: Results from the Patient and Provider Assessment of Lipid Management (PALM) Registry (Michele Nanna)
Sunday, March 17, 12:30-12:40 PM CT - Patient Perceptions and Management of Cholesterol Among Individuals with or without Diabetes in Community Practice: Results from the PALM Registry (Angela Lowenstern)
Sunday, March 17, 1:30-1:40 PM CT
About ODYSSEY OUTCOMES
ODYSSEY OUTCOMES (n=18,924) assessed the effect of Praluent on the occurrence of major adverse CV events (MACE) in patients who had experienced an ACS between 1-12 months (median 2.6 months) before enrolling in the trial, and who were already on intensive or maximally-tolerated statin treatment. Patients were randomized to receive Praluent (n=9,462) or a placebo (n=9,462) and were assessed for a median of 2.8 years, with some patients being treated for up to five years. Approximately 90% of patients were on a high-intensity statin.
The trial was designed to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg). Praluent-treated patients started the trial on 75 mg every 2 weeks and switched to 150 mg every 2 weeks if their LDL-C levels remained above 50 mg/dL (n=2,615). Some patients who switched to 150 mg switched back to 75 mg if their LDL-C fell below 25 mg/dL (n=805), and patients who experienced two consecutive LDL-C measurements below 15 mg/dL while on the 75 mg dose (n=730) stopped active Praluent therapy for the remainder of the trial.
About Praluent
Praluent® (alirocumab) Injection inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company's proprietary VelocImmune® technology that yields optimized fully-human monoclonal antibodies.
Praluent is approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Brazil and the 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 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 Sanofi
Sanofi 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.
Sanofi, Empowering Life
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 for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting 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.