Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: Rationale and design of the ODYSSEY Outcomes trial

Publication date: Available online 7 August 2014 Source:American Heart Journal Author(s): Gregory G. Schwartz , Laurence Bessac , Lisa G. Berdan , Deepak L. Bhatt , Vera Bittner , Rafael Diaz , Shaun G. Goodman , Corinne Hanotin , Robert A. Harrington , J. Wouter Jukema , Kenneth W. Mahaffey , Angèle Moryusef , Robert Pordy , Matthew T. Roe , Tyrus Rorick , William J. Sasiela , Cheerag Shirodaria , Michael Szarek , Jean-François Tamby , Pierluigi Tricoci , Harvey White , Andreas Zeiher , Philippe Gabriel Steg Following acute coronary syndrome (ACS), the risk for future cardiovascular events is high and is related to levels of low-density lipoprotein cholesterol (LDL-C) even within the setting of intensive statin treatment. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates LDL receptor expression and circulating levels of LDL-C. Antibodies to PCSK9 can produce substantial and sustained reductions of LDL-C. The ODYSSEY Outcomes trial tests the hypothesis that treatment with alirocumab, a fully human monoclonal antibody to PCSK9, improves cardiovascular outcomes after ACS. Design This Phase 3 study will randomize approximately 18,000 patients to receive biweekly injections of alirocumab (75-150 mg) or matching placebo beginning 1 to 12 months after an index hospitalization for acute myocardial infarction or unstable angina. Qualifying patients are treated with atorvastatin 40 or 80 mg daily, rosuvastatin 20 or 40 mg daily, or the maxi...
Source: American Heart Journal - Category: Cardiology Source Type: research