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, Paul 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 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)
JournalJournal of Clinical Lipidology
DOIs
StateAccepted/In press - Oct 22 2015

Fingerprint

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

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

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, Paul; 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, 22.10.2015.

Research output: Contribution to journalArticle

Moriarty, PM, Parhofer, KG, Babirak, SP, deGoma, E, Duell, P, Hohenstein, B, Ramlow, W, Simha, V, Steinhagen-Thiessen, E, Thompson, PD, Vogt, A, von Stritzky, B, Du, Y & Manvelian, G 2015, 'Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis: Rationale and design of the ODYSSEY ESCAPE trial', Journal of Clinical Lipidology. https://doi.org/10.1016/j.jacl.2016.02.003
Moriarty, Patrick M. ; Parhofer, Klaus G. ; Babirak, Stephan P. ; deGoma, Emil ; Duell, Paul ; 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. 2015.
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T2 - Rationale and design of the ODYSSEY ESCAPE trial

AU - Moriarty, Patrick M.

AU - Parhofer, Klaus G.

AU - Babirak, Stephan P.

AU - deGoma, Emil

AU - Duell, Paul

AU - Hohenstein, Bernd

AU - Ramlow, Wolfgang

AU - Simha, Vinaya

AU - Steinhagen-Thiessen, Elisabeth

AU - Thompson, Paul D.

AU - Vogt, Anja

AU - von Stritzky, Berndt

AU - Du, Yunling

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.

AB - 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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