Journal article
Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial
The journal of clinical endocrinology and metabolism, Vol.100(8), pp.3140-3148
08/2015
DOI: 10.1210/jc.2015-1520
PMCID: PMC4524987
PMID: 26030325
Abstract
Despite current standard of care, many patients at high risk of cardiovascular disease (CVD) still have elevated low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9.
The objective of the study was to compare the LDL-C-lowering efficacy of adding alirocumab vs other common lipid-lowering strategies.
Patients (n = 355) with very high CVD risk and LDL-C levels of 70 mg/dL or greater or high CVD risk and LDL-C of 100 mg/dL or greater on baseline atorvastatin 20 or 40 mg were randomized to one of the following: 1) add-on alirocumab 75 mg every 2 weeks (Q2W) sc; 2) add-on ezetimibe 10 mg/d; 3) double atorvastatin dose; or 4) for atorvastatin 40 mg regimen only, switch to rosuvastatin 40 mg. For patients not achieving protocol-defined LDL-C goals, the alirocumab dose was increased (blinded) at week 12 to 150 mg Q2W.
The primary end point was percentage change in calculated LDL-C from baseline to 24 weeks (intent to treat).
Among atorvastatin 20 and 40 mg regimens, respectively, add-on alirocumab reduced LDL-C levels by 44.1% and 54.0% (P < .001 vs all comparators); add-on ezetimibe, 20.5% and 22.6%; doubling of atorvastatin dose, 5.0% and 4.8%; and switching atorvastatin 40 mg to rosuvastatin 40 mg, 21.4%. Most alirocumab-treated patients (87.2% and 84.6%) achieved their LDL-C goals. Most alirocumab-treated patients (86%) maintained their 75-mg Q2W regimen. Treatment-emergent adverse events occurred in 65.4% of alirocumab patients vs 64.4% ezetimibe and 63.8% double atorvastatin/switch to rosuvastatin (data were pooled).
Adding alirocumab to atorvastatin provided significantly greater LDL-C reductions vs adding ezetimibe, doubling atorvastatin dose, or switching to rosuvastatin and enabled greater LDL-C goal achievement.
Details
- Title: Subtitle
- Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial
- Creators
- Harold Bays - Louisville Metabolic and Atherosclerosis Research CenterDaniel Gaudet - Université de MontréalRobert Weiss - Maine Research AssociatesJuan Lima Ruiz - Vall d'Hebron Hospital UniversitariGerald F Watts - The University of Western AustraliaIoanna Gouni-Berthold - University of CologneJennifer Robinson - University of Iowa, Internal MedicineJian Zhao - RegeneronCorinne Hanotin - Foundation SStephen Donahue - Regeneron
- Resource Type
- Journal article
- Publication Details
- The journal of clinical endocrinology and metabolism, Vol.100(8), pp.3140-3148
- DOI
- 10.1210/jc.2015-1520
- PMID
- 26030325
- PMCID
- PMC4524987
- NLM abbreviation
- J Clin Endocrinol Metab
- ISSN
- 0021-972X
- eISSN
- 1945-7197
- Publisher
- United States
- Language
- English
- Date published
- 08/2015
- Academic Unit
- Epidemiology
- Record Identifier
- 9983995155802771
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