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  • Efficacy and Safety of Alir...
    Robinson, Jennifer G; Farnier, Michel; Krempf, Michel; Bergeron, Jean; Luc, Gérald; Averna, Maurizio; Stroes, Erik S; Langslet, Gisle; Raal, Frederick J; El Shahawy, Mahfouz; Koren, Michael J; Lepor, Norman E; Lorenzato, Christelle; Pordy, Robert; Chaudhari, Umesh; Kastelein, John J.P

    The New England journal of medicine, 04/2015, Letnik: 372, Številka: 16
    Journal Article

    In a randomized trial, alirocumab (a monoclonal antibody that inhibits PCSK9), as compared with placebo, reduced LDL cholesterol levels by an additional 62 percentage points. In a post hoc analysis, the incidence of cardiovascular events was reduced with alirocumab. Monoclonal antibodies to proprotein convertase subtilisin–kexin type 9 (PCSK9) have been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are being treated with statins. In phase 2 studies lasting 8 to 12 weeks, the PCSK9 inhibitor alirocumab lowered LDL cholesterol levels by 40 to 70% when added to background statin therapy. 1 – 3 However, this new treatment needs to be evaluated in larger populations for longer periods of follow-up to establish its safety and efficacy. 4 – 7 We conducted a 78-week trial comparing alirocumab (150 mg every 2 weeks) with placebo in 2341 patients at high risk for cardiovascular . . .