Journal article
Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study
Journal of the American Heart Association, Vol.5(9), e003421
09/13/2016
DOI: 10.1161/JAHA.116.003421
PMCID: PMC5079013
PMID: 27625344
Abstract
The PCSK9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low-density lipoprotein-cholesterol (LDL-C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin-associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone.
Patients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL-C target levels were not met. The primary efficacy endpoint was LDL-C percentage change from baseline to W24. Mean baseline LDL-C levels were 163.9 mg/dL (alirocumab 150 mg Q4W, n=59), 154.5 mg/dL (alirocumab 75 mg Q2W, n=116), and 158.5 mg/dL (placebo, n=58). In the alirocumab 150 mg Q4W and 75 mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least-squares mean LDL-C changes from baseline to W24 were -51.7% and -53.5%, respectively (placebo [+4.7%]; both groups P<0.0001 versus placebo). In total, 63.9% and 70.3% of alirocumab-treated patients achieved their LDL-C targets at W24. Treatment-emergent adverse events occurred in 77.6% (alirocumab 150 mg Q4W), 73.0% (alirocumab 75 mg Q2W), and 63.8% (placebo) of patients, with injection-site reactions among the most common treatment-emergent adverse events.
Alirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL-C.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02023879.
Details
- Title: Subtitle
- Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study
- Creators
- Erik Stroes - Academic Medical CenterJohn R Guyton - Duke Medical CenterNorman Lepor - Westside Medical Associates of Los AngelesFernando Civeira - Hospital Universitario Miguel ServetDaniel Gaudet - Université du Québec à ChicoutimiGerald F Watts - Royal Perth HospitalMarie T Baccara-Dinet - SanofiGuillaume Lecorps - SanofiGaren Manvelian - RegeneronMichel Farnier - Lipid Clinic, Point Médical, Dijon, France.ODYSSEY CHOICE II Investigators
- Contributors
- Jennifer G Robinson (Contributor) - University of Iowa, Fraternal Order of Eagles Diabetes Research Center
- Resource Type
- Journal article
- Publication Details
- Journal of the American Heart Association, Vol.5(9), e003421
- DOI
- 10.1161/JAHA.116.003421
- PMID
- 27625344
- PMCID
- PMC5079013
- ISSN
- 2047-9980
- eISSN
- 2047-9980
- Language
- English
- Date published
- 09/13/2016
- Academic Unit
- Epidemiology; Fraternal Order of Eagles Diabetes Research Center
- Record Identifier
- 9984364406102771
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