Document Detail

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.
MedLine Citation:
PMID:  25440796     Owner:  NLM     Status:  In-Data-Review    
BACKGROUND: 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 maximum tolerated and approved dose of one of these agents and fulfill one of the following criteria: LDL-C ≥ 70 mg/dL, non-high-density lipoprotein cholesterol ≥ 100 mg/dL, or apolipoprotein B ≥ 80 mg/dL. The primary efficacy measure is time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or ischemic stroke. The trial is expected to continue until 1613 primary end point events have occurred with minimum follow-up of at least 2 years, providing 90% power to detect a 15% hazard reduction. Adverse events of special interest include allergic events and injection site reactions. Interim analyses are planned when approximately 50% and 75% of the targeted number of primary end points have occurred.
SUMMARY: ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS.
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
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Publication Detail:
Type:  Journal Article     Date:  2014-08-07
Journal Detail:
Title:  American heart journal     Volume:  168     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2014 Nov 
Date Detail:
Created Date:  2014-12-02     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  682-689.e1     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.
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