ODYSSEY ESCAPE - ODYSSEY ESCAPE

Aug 29, 2016
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Sanofi and Regeneron Pharmaceuticals, Inc.
Date Presented:
08/29/2016
Date Published:
08/29/2016
Original Posted Date:
08/29/2016
References

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


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