Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study

Erik Stroes, J. Guyton, N. Lepor, F. Civeira, Daniel Gaudet, Gerald F. Watts, Marie T. Baccara-Dinet, Guillaume Lecorps, Garen Manvelian, for the ODYSSEY CHOICE II Investigators, K. Kostner, S. Lehman, G. Watts, O. Descamps, L. Gheyle, C. Mathieu, J. Bergeron, T. Elliott, D. Gaudet, G. GirardA. Gupta, G. Hoag, J. Hove, J. Jeppesen, J. H. Kjærulf, K. Klarlund, K. K. Thomsen, D. C.G. Basart, A. Kooy, A. Liem, J. E.S.G. Stroes, H. Swart, R. Troquay, J. Van Het Hof-Wiersma, P. Viergever, F. Visseren, R. N. Doughty, R. Scott, C. Calvo, F. Civeira, J. L. Díaz-Díaz, F. Fuentes, B. Gil-Extremera, C. Jericó, L. Matas Pericas, J. D. Mediavilla Garcia, D. E. Bolster, J. Guyton, M. Koren, N. Lepor, M. El Shahawy, G. Vardi, D. Weinstein, K. Zuzarte, Henry Ginsberg, Jennifer G. Robinson, Daniel J. Rader, Christopher P. Cannon, Helen Colhoun, John J.P. Kastelein, Michel Farnier, Yong Huo, Anders Olsson, David Waters, Dominique Larrey, Robert S. Rosenson, Peter A. Patriarca, Geert Molenberghs, Pierluigi Tricoci, Kenneth W. Mahaffey, Renato D. Lopes, Bimal R. Shah, Rajendra H. Mehta, Matthew T. Roe, Zubin Eapen, Luciana Armaganijan, Adriana Bertolami, Sergio Leonardi, Bradley J. Kolls, Joseph Dedrick Jordan, Grégory Ducrocq, Etienne Puymirat, Robin Mathews

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    Abstract

    Background: The PCSK9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low-density lipoprotein-cholesterol (LDL-C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin-associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone. Methods and Results: Patients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL-C target levels were not met. The primary efficacy endpoint was LDL-C percentage change from baseline to W24. Mean baseline LDL-C levels were 163.9 mg/dL (alirocumab 150 mg Q4W, n=59), 154.5 mg/dL (alirocumab 75 mg Q2W, n=116), and 158.5 mg/dL (placebo, n=58). In the alirocumab 150 mg Q4W and 75 mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least-squares mean LDL-C changes from baseline to W24 were -51.7% and -53.5%, respectively (placebo [+4.7%]; both groups P<0.0001 versus placebo). In total, 63.9% and 70.3% of alirocumab-treated patients achieved their LDL-C targets at W24. Treatment-emergent adverse events occurred in 77.6% (alirocumab 150 mg Q4W), 73.0% (alirocumab 75 mg Q2W), and 63.8% (placebo) of patients, with injection-site reactions among the most common treatment-emergent adverse events. Conclusions: Alirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL-C.

    Original languageEnglish
    Article numbere003421
    Number of pages36
    JournalJournal of the American Heart Association
    Volume5
    Issue number9
    DOIs
    Publication statusPublished - 1 Sep 2016

    Keywords

    • Alirocumab
    • Cardiovascular risk
    • Low-density lipoprotein cholesterol
    • Placebo-controlled
    • Proprotein convertase subtilisin/kexin type 9

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