Patrick M Moriarty1, Klaus G Parhofer2, Stephan P Babirak3, Emil deGoma4, P Barton Duell5, Bernd Hohenstein6, Wolfgang Ramlow7, Vinaya Simha8, Elisabeth Steinhagen-Thiessen9, Paul D Thompson10, Anja Vogt11, Berndt von Stritzky12, Yunling Du13, Garen Manvelian14. 1. Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA. Electronic address: pmoriart@kumc.edu. 2. Medical Department II, Grosshadern, University Munich, Munich, Germany. 3. Metabolic Leader, LLC, Scarborough, PA, USA. 4. University of Pennsylvania, Philadelphia, PA, USA. 5. Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA. 6. Extracorporeal Treatment and Lipoprotein Apheresis Center, Department of Internal Medicine III, University Hospital Carl Gustav Carus, Technische Universitaet Dresden, Dresden, Germany. 7. Apheresis Centrum Rostock, Rostock, Germany. 8. Mayo Clinic, Rochester, MN, USA. 9. Charite-Universitätsmedizin Berlin-Campus Virchow-Klinikum, Berlin, Germany. 10. Cardiology, Hartford Hospital, Hartford, CT, USA. 11. Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, Germany. 12. Medical Department, Sanofi-Aventis Deutschland GmbH, Berlin, Germany. 13. Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA. 14. Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
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) orQ2W (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.
RCT Entities:
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.
Authors: Mohammed Al Dubayee; Meral Kayikcioglu; Jeanine Roeters van Lennep; Nadia Hergli; Pedro Mata Journal: Adv Ther Date: 2022-04-26 Impact factor: 4.070
Authors: Patrick M Moriarty; Klaus G Parhofer; Stephan P Babirak; Marc-Andre Cornier; P Barton Duell; Bernd Hohenstein; Josef Leebmann; Wolfgang Ramlow; Volker Schettler; Vinaya Simha; Elisabeth Steinhagen-Thiessen; Paul D Thompson; Anja Vogt; Berndt von Stritzky; Yunling Du; Garen Manvelian Journal: Eur Heart J Date: 2016-08-29 Impact factor: 29.983