TY  - JOUR
A1  - Schwartz, Gregory G.
A1  - Bessac, Laurence
A1  - Berdan, Lisa G.
A1  - Bhatt, Deepak L.
A1  - Bittner, Vera
A1  - Diaz, Rafael
A1  - Goodman, Shaun G.
A1  - Hanotin, Corinne
A1  - Harrington, Robert A.
A1  - Jukema, J. Wouter
A1  - Mahaffey, Kenneth
A1  - Moryusef, Angèle
A1  - Pordy, Robert
A1  - Roe, Matthew T.
A1  - Rorick, Tyrus
A1  - Sasiela, William J.
A1  - Shirodaria, Cheerag
A1  - Szarek, Michael
A1  - Tamby, Jean-François
A1  - Tricoci, Pierluigi
A1  - White, Harvey
A1  - Zeiher, Andreas M.
A1  - Steg, P. Gabriel
T1  - 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
T2  - American heart journal
N2  - 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.
Y1  - 2014
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/37292
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-372926
SN  - 1097-6744
SN  - 0002-8703
N1  - © 2014 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
VL  - 168
IS  - 5
SP  - 682
EP  - 689
PB  - Elsevier
CY  - Amsterdam
ER  -