Effect of REGN727SAR236553 PCSK9 Fully Human Monoclonal.pptVIP

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2016-10-07 发布于重庆
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Effect of REGN727SAR236553 PCSK9 Fully Human Monoclonal.ppt

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Effect of REGN727SAR236553 PCSK9 Fully Human Monoclonal

* Note: in this presentation, final patient HeFH status is as reported in the e-CRF, both for efficacy and safety analyses (whereas in the abstract, the heFH status as per IVRS was used for efficacy interim analyses). As a consequence, there are some small differences vs the data presented in the abstract. * HeFH diagnosis was either by genotyping or clinical criteria (Simon Broome criteria or World Health Organisation/Dutch Lipid Network criteria with a score of 8 points). * * * * * * * * * * * * * * * Efficacy and Safety of the PCSK9 Monoclonal Antibody Alirocumab versus Placebo in 1257 Patients with Heterozygous Familial Hypercholesterolaemia: Analyses up to 78 Weeks from Four ODYSSEY Trials John J.P. Kastelein1, Michel Farnier2, G. Kees Hovingh1, Gisle Langslet3, Marie T. Baccara-Dinet4, Daniel A. Gipe5, Umesh Chaudhari6, Jian Zhao7, Christelle Lorenzato8, Henry N. Ginsberg9 1Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; 2Lipid Clinic, Point Médical, Dijon, France; 3Lipid Clinic, Oslo University Hospital, Oslo, Norway; 4Sanofi, Montpellier, France; 5Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 6Sanofi, Bridgewater, NJ, USA;7Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA; 8Sanofi, Paris, France; 9Columbia University, New York, NY, USA This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Author Disclosure John J.P. Kastelein Honoraria from Dezima Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Sanofi, Eli Lilly, Pfizer, Amgen, Genzyme, Aegerion, Esperion, and Isis Pharmaceuticals, and consultant/advisory board fees from Dezima Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Sanofi, Eli Lilly, Pfizer, Amgen, Genzyme, Aegerion, Esperion, and Isis Pharmaceuticals. Michel Farnier Received research support from Amgen, Merck, and Sanofi, speaker’s bureau fees from Amgen, Sanofi, and Merck, honoraria from Abbott, Eli Lilly, and Pfizer, and consultant/advisory board