TY - JOUR
T1 - Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis
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, 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
AU - Du, Yunling
AU - Manvelian, Garen
N1 - Publisher Copyright:
© 2016 National Lipid Association. All rights reserved.
PY - 2016/5/1
Y1 - 2016/5/1
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.
KW - Alirocumab
KW - Familial hypercholesterolemia
KW - Low-density lipoprotein cholesterol
KW - Monoclonal antibody
KW - Proprotein convertase subtilisin/kexin type 9
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U2 - 10.1016/j.jacl.2016.02.003
DO - 10.1016/j.jacl.2016.02.003
M3 - Article
C2 - 27206951
AN - SCOPUS:84962518331
SN - 1933-2874
VL - 10
SP - 627
EP - 634
JO - Journal of Clinical Lipidology
JF - Journal of Clinical Lipidology
IS - 3
ER -