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

10 Citations (Scopus)

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

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Hyperlipoproteinemia Type II
Blood Component Removal
Lipoproteins
LDL Cholesterol
Placebos
alirocumab
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Germany
Appointments and Schedules
Therapeutics
Lipids
Safety
Injections

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

Cite this

Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis : Rationale and design of the ODYSSEY ESCAPE trial. / Moriarty, Patrick M.; Parhofer, Klaus G.; Babirak, Stephan P.; Degoma, Emil; Duell, P. Barton; Hohenstein, Bernd; Ramlow, Wolfgang; Simha, Vinaya; Steinhagen-Thiessen, Elisabeth; Thompson, Paul D.; Vogt, Anja; Von Stritzky, Berndt; Du, Yunling; Manvelian, Garen.

In: Journal of Clinical Lipidology, Vol. 10, No. 3, 01.05.2016, p. 627-634.

Research output: Contribution to journalArticle

Moriarty, PM, Parhofer, KG, Babirak, SP, Degoma, E, Duell, PB, Hohenstein, B, Ramlow, W, Simha, V, Steinhagen-Thiessen, E, Thompson, PD, 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, vol. 10, no. 3, pp. 627-634. https://doi.org/10.1016/j.jacl.2016.02.003
Moriarty, Patrick M. ; Parhofer, Klaus G. ; Babirak, Stephan P. ; Degoma, Emil ; Duell, P. Barton ; Hohenstein, Bernd ; Ramlow, Wolfgang ; Simha, Vinaya ; Steinhagen-Thiessen, Elisabeth ; Thompson, Paul D. ; Vogt, Anja ; Von Stritzky, Berndt ; Du, Yunling ; Manvelian, Garen. / Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis : Rationale and design of the ODYSSEY ESCAPE trial. In: Journal of Clinical Lipidology. 2016 ; Vol. 10, No. 3. pp. 627-634.
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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.",
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T2 - Rationale and design of the ODYSSEY ESCAPE trial

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AU - Parhofer, Klaus G.

AU - Babirak, Stephan P.

AU - Degoma, Emil

AU - Duell, P. Barton

AU - Hohenstein, Bernd

AU - Ramlow, Wolfgang

AU - Simha, Vinaya

AU - Steinhagen-Thiessen, Elisabeth

AU - Thompson, Paul D.

AU - Vogt, Anja

AU - Von Stritzky, Berndt

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AU - Manvelian, Garen

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N2 - 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.

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