Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis: Rationale and design of the ODYSSEY ESCAPE trial

Patrick M. Moriarty, Klaus G. Parhofer, Stephan P. Babirak, Emil Degoma, P. Barton Duell, Bernd Hohenstein, Wolfgang Ramlow, Vinaya Simha, Elisabeth Steinhagen-Thiessen, Paul D. Thompson, Anja Vogt, Berndt Von Stritzky, Yunling Du, Garen Manvelian

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

Background Many patients with heterozygous familial hypercholesterolemia (HeFH) fail to reach optimal low-density lipoprotein cholesterol (LDL-C) levels with available lipid-lowering medications, including statins, and require treatment using alternative methods such as lipoprotein apheresis. Objective To evaluate the efficacy of alirocumab 150 mg every 2 weeks (Q2W) compared with placebo in reducing the frequency of lipoprotein apheresis treatments in patients with HeFH. Methods ODYSSEY ESCAPE is a randomized, double-blind, placebo-controlled, parallel-group, 18-week, phase 3 study being conducted in the United States and Germany. ODYSSEY ESCAPE will evaluate the efficacy and safety of alirocumab in approximately 63 adults with HeFH undergoing regular weekly (QW; for ≥4 weeks) or Q2W (for ≥8 weeks) lipoprotein apheresis. Patients will be randomly assigned (2:1, respectively) to receive alirocumab 150 mg subcutaneously Q2W or placebo subcutaneously Q2W (both in 1-mL injections) for 18 weeks. From day 1 to week 6, the apheresis frequency will be fixed to the individual patient's established schedule (QW or Q2W); thereafter, apheresis will be performed according to the LDL-C value at that visit: apheresis will not be performed when the LDL-C value is ≥30% lower than the baseline pre-apheresis LDL-C value. The primary end point is the frequency of apheresis treatments over a 12-week period starting at week 7. Discussion The ODYSSEY ESCAPE trial will determine whether alirocumab reduces the frequency of lipoprotein apheresis in patients with HeFH.

Original languageEnglish (US)
Pages (from-to)627-634
Number of pages8
JournalJournal of clinical lipidology
Volume10
Issue number3
DOIs
StatePublished - May 1 2016

Keywords

  • Alirocumab
  • Familial hypercholesterolemia
  • Low-density lipoprotein cholesterol
  • Monoclonal antibody
  • Proprotein convertase subtilisin/kexin type 9

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics
  • Cardiology and Cardiovascular Medicine

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    Moriarty, P. M., Parhofer, K. G., Babirak, S. P., Degoma, E., Duell, P. B., Hohenstein, B., Ramlow, W., Simha, V., Steinhagen-Thiessen, E., Thompson, P. D., Vogt, A., Von Stritzky, B., Du, Y., & Manvelian, G. (2016). Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis: Rationale and design of the ODYSSEY ESCAPE trial. Journal of clinical lipidology, 10(3), 627-634. https://doi.org/10.1016/j.jacl.2016.02.003