Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial Robert Dufour, MD, MSc, CSPQ, G. Kees Hovingh, MD, PhD, MBA, John R. Guyton, MD, Gisle Langslet, MD, Marie T. Baccara-Dinet, MD, MSc, Chantal Din-Bell, MSc, Garen Manvelian, MD, Michel Farnier, MD, PhD Journal of Clinical Lipidology Volume 13, Issue 1, Pages 138-147 (January 2019) DOI: 10.1016/j.jacl.2018.11.007 Copyright © 2018 National Lipid Association Terms and Conditions
Figure 1 OLE study design. aPatients receiving placebo were part of the OLE study but were not included in this analysis. bPosttreatment follow-up call to be performed 10 weeks after the last injection. HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; NCEP ATP III, National Cholesterol Education Program Adult Treatment Panel III; OLE, open-label extension; Q2W, every 2 weeks; TLC, therapeutic lifestyle changes; W, week. Journal of Clinical Lipidology 2019 13, 138-147DOI: (10.1016/j.jacl.2018.11.007) Copyright © 2018 National Lipid Association Terms and Conditions
Figure 2 Percent LDL-C change from baseline to Week 8 in the LONG TERM parent study and the OLE study, in the same cohort of HeFH patients (mITT analysis)a. aOnly patients who have all 4 LDL-C measurements (parent study baseline, OLE baseline, Week 8 parent study, and Week 8 OLE study) are included in this analysis. bResults for patient cohort during the LONG TERM study (n = 179). cResults for patient cohort during the OLE study (n = 179). LDL-C, low-density lipoprotein cholesterol; Q2W, every 2 weeks; mITT, modified intent-to-treat; SD, standard deviation; SE, standard error. Journal of Clinical Lipidology 2019 13, 138-147DOI: (10.1016/j.jacl.2018.11.007) Copyright © 2018 National Lipid Association Terms and Conditions
Figure 3 Percent change in (A) HDL-C, (B) non-HDL-C, (C) TC, and (D) TGs from baseline to Week 8 in the LONG TERM parent study and OLE study, in the same cohort of HeFH patients (mITT analysis). Patient numbers for each lipid parameter are as follows: HDL-C, non-HDL-C, and TC, n = 185; TGs, and n = 182 respectively. aResults for patient cohort during the LONG TERM study. bResults for patient cohort during the OLE study. HDL-C, high-density lipoprotein cholesterol; mITT, modified intention-to-treat; Q2W, every 2 weeks; SD, standard deviation; SE, standard error; TC, total cholesterol; TGs, triglycerides. Journal of Clinical Lipidology 2019 13, 138-147DOI: (10.1016/j.jacl.2018.11.007) Copyright © 2018 National Lipid Association Terms and Conditions
Figure 4 Mean (SD) LDL-C levels over time according to alirocumab dose increase status in OLE (mITT analysis). LDL-C, low-density lipoprotein cholesterol; mITT, modified intention-to-treat; Q2W, every 2 weeks; SD, standard deviation. Journal of Clinical Lipidology 2019 13, 138-147DOI: (10.1016/j.jacl.2018.11.007) Copyright © 2018 National Lipid Association Terms and Conditions