Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial.

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Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia John J.P. Kastelein, MD, PhD, FESC, G. Kees Hovingh, MD, PhD, Gisle Langslet, MD, Marie T. Baccara-Dinet, MD, Daniel A. Gipe, MD, Umesh Chaudhari, MD, Jian Zhao, MS, Pascal Minini, PhD, Michel Farnier, MD, PhD Journal of Clinical Lipidology Volume 11, Issue 1, Pages 195-203.e4 (January 2017) DOI: 10.1016/j.jacl.2016.12.004 Copyright © 2016 National Lipid Association Terms and Conditions

Figure 1 Overview of studies included in this analysis. *Concomitant statin at maximally tolerated doses (atorvastatin 40–80 mg, rosuvastatin 20–40 mg, or simvastatin 80 mg; lower doses allowed with an investigator-justified reason). †75/150 mg Q2W indicates that the starting dose of 75 mg Q2W could be increased to 150 mg Q2W at week 12 if LDL-C was ≥70 mg/dL at week 8. CV, cardiovascular; HeFH, heterozygous familial hypercholesterolaemia; LDL-C, low-density lipoprotein; LLT, lipid-lowering therapy; Q2W, every 2 weeks. N values represent numbers of randomized patients. Journal of Clinical Lipidology 2017 11, 195-203.e4DOI: (10.1016/j.jacl.2016.12.004) Copyright © 2016 National Lipid Association Terms and Conditions

Figure 2 Investigator-approved reasons why patients were not receiving a high-dose statin* in studies requiring participants to be on maximally tolerated statin† (randomized population). *High-dose statin defined as atorvastatin 40 to 80 mg, rosuvastatin 20 to 40 mg, or simvastatin 80 mg. †All patients in the pool of FH I and FH II studies and LONG TERM and HIGH FH studies were required to be on maximally tolerated statin, ideally a high-dose statin, at study entry, although lower doses were allowed with an investigator-approved reason. ‖A patient can be counted in several categories. ALI, alirocumab; BG, blood glucose; CPK, creatine phosphokinase; HbA1c, glycated hemoglobin; LFT, liver function test; PBO, placebo. Journal of Clinical Lipidology 2017 11, 195-203.e4DOI: (10.1016/j.jacl.2016.12.004) Copyright © 2016 National Lipid Association Terms and Conditions

Figure 3 Calculated LDL-C values over the study period in (A) the FH I and II pool and (B) the HIGH FH and LONG TERM pool (on-treatment analysis). †ΔW24/52/78 = LS mean percentage difference vs placebo in calculated LDL-C from baseline to weeks 24, 52, and 78. LDL-C, low-density lipoprotein cholesterol; LS, least squares; Q2W, every 2 weeks. Journal of Clinical Lipidology 2017 11, 195-203.e4DOI: (10.1016/j.jacl.2016.12.004) Copyright © 2016 National Lipid Association Terms and Conditions