ODYSSEY ESCAPE - ODYSSEY ESCAPE
Contribution To Literature:
The ODYSSEY ESCAPE trial showed that alirocumab was superior to placebo at reducing the need for apheresis therapy.
Description:
The goal of the trial was to evaluate treatment with subcutaneous alirocumab compared with placebo among patients with heterozygous familial hypercholesterolemia (HeFH) undergoing apheresis.
Study Design
- Randomized
- Parallel
- Placebo
- Double-Blind
Patients with HeFH undergoing apheresis were randomized to subcutaneous alirocumab 150 mg every 2 weeks (n = 41) versus placebo every 2 weeks (n = 21). The apheresis schedule was fixed for 6 weeks; however, if low-density lipoprotein cholesterol (LDL-C) was reduced at least 30%, further apheresis could be skipped.
Inclusion criteria:
- Patients at least 18 years of age with HeFH
- On stable background lipid-lowering therapy
- Undergoing lipoprotein apheresis therapy
- Total number of enrollees: 62
- Duration of follow-up: 18 weeks
- Mean patient age: 60 years
- Percentage female: 37%
Principal Findings:
There was a 75% reduction in the need for apheresis among alirocumab- versus placebo-treated patients (p < 0.0001). Apheresis was discontinued in 63% of patients.
Secondary outcomes:
- Percent change in LDL-C from baseline: 42.5% with alirocumab versus 3.9% with placebo (p < 0.0001)
- Treatment-emergent serious adverse event: 4% with alirocumab versus 2% with placebo (p = NS)
Interpretation:
Among patients with HeFH undergoing apheresis, the use of alirocumab reduced the need for apheresis therapy compared with placebo. Alirocumab was associated with a 50% reduction in LDL-C compared with placebo. Adverse events were similar between study medication and placebo.
References:
Moriarty PM, Parhofer KG, Babirak SP, et al. Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial. Eur Heart J 2016;Aug 29:[Epub ahead of print].
Presented by Dr. Patrick Moriarty at the European Society of Cardiology Congress, Rome, Italy, August 29, 2016.
Keywords: Antibodies, Monoclonal, Blood Component Removal, Cholesterol, LDL, Dyslipidemias, Hyperlipoproteinemia Type II, Lipoproteins, Primary Prevention, ESC Congress
< Back to Listings