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.
The goal of the trial was to evaluate treatment with subcutaneous alirocumab compared with placebo among patients with heterozygous familial hypercholesterolemia (HeFH) undergoing apheresis.
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.
- 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%
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.
- 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)
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.
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.
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