Abstract |
The phase 3 ODYSSEY OPTIONS studies (OPTIONS I, NCT01730040; OPTIONS II, NCT01730053) are multicenter, multinational, randomized, double-blind, active-comparator, 24-week studies evaluating the efficacy and safety of alirocumab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, as add-on therapy in ∼ 650 high-cardiovascular (CV)-risk patients whose low-density lipoprotein cholesterol ( LDL-C) levels are ≥100 mg/dL or ≥70 mg/dL according to the CV-risk category, high and very high CV risk, respectively, with atorvastatin (20-40 mg/d) or rosuvastatin (10-20 mg/d). Patients are randomized to receive alirocumab 75 mg via a single, subcutaneous, 1-mL injection by prefilled pen every 2 weeks (Q2W) as add-on therapy to atorvastatin (20-40 mg) or rosuvastatin (10-20 mg); or to receive ezetimibe 10 mg/d as add-on therapy to statin; or to receive statin up-titration; or to switch from atorvastatin to rosuvastatin (OPTIONS I only). At week 12, based on week 8 LDL-C levels, the alirocumab dose may be increased from 75 mg to 150 mg Q2W if LDL-C levels remain ≥100 mg/dL or ≥70 mg/dL in patients with high or very high CV risk, respectively. The primary efficacy endpoint in both studies is difference in percent change in calculated LDL-C from baseline to week 24 in the alirocumab vs control arms. The studies may provide guidance to inform clinical decision-making when patients with CV risk require additional lipid-lowering therapy to further reduce LDL-C levels. The flexibility of the alirocumab dosing regimen allows for individualized therapy based on the degree of LDL-C reduction required to achieve the desired LDL-C level.
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Authors | Jennifer G Robinson, Helen M Colhoun, Harold E Bays, Peter H Jones, Yunling Du, Corinne Hanotin, Stephen Donahue |
Journal | Clinical cardiology
(Clin Cardiol)
Vol. 37
Issue 10
Pg. 597-604
(Oct 2014)
ISSN: 1932-8737 [Electronic] United States |
PMID | 25269777
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2014 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc. |
Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Anticholesteremic Agents
- Cholesterol, LDL
- Fluorobenzenes
- Heptanoic Acids
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Pyrimidines
- Pyrroles
- Sulfonamides
- Rosuvastatin Calcium
- Atorvastatin
- alirocumab
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Topics |
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Anticholesteremic Agents
(therapeutic use)
- Atorvastatin
- Cardiovascular Diseases
(etiology, prevention & control)
- Cholesterol, LDL
(blood)
- Dose-Response Relationship, Drug
- Drug Therapy, Combination
- Female
- Fluorobenzenes
(therapeutic use)
- Heptanoic Acids
(therapeutic use)
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(therapeutic use)
- Hypercholesterolemia
(complications, drug therapy)
- Male
- Pyrimidines
(therapeutic use)
- Pyrroles
(therapeutic use)
- Rosuvastatin Calcium
- Sulfonamides
(therapeutic use)
- Treatment Outcome
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