LAPLACE-TIMI 57 assessed whether 12 weeks of therapy with a novel injectable monoclonal antibody against PCSK9, given on a background of statin therapy, will be safe and to what degree it will reduce LDL-cholesterol in hypercholesterolemic subjects.
Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study
Lancet. 2012 Dec 8;380(9858):2007-17
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AMG145, a Monoclonal Antibody Against Proprotein Convertase Subtilisin Kexin Type 9, Significantly Reduces Lipoprotein(a) in Hypercholesterolemic Patients Receiving Statin Therapy: An Analysis From the LDL-C Assessment With Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition Combined With Statin Therapy (LAPLACE)-Thrombolysis in Myocardial Infarction (TIMI) 57 Trial. Circulation. 2013 Aug 27;128(9):962-9.
AMG 145, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9), Facilitates Achievement of NCEP LDL-Cholesterol Goals in High-Risk Patients. J Am Coll Cardiol. 2014 Feb 11;63(5):430-3.
AMG 145, A Monoclonal Antibody Against PCSK9, Facilitates Achievement of NCEP-ATP III LDL-C Goals Among High Risk Patients: An Analysis From the LAPLACE-TIMI 57 Trial. J Am Coll Cardiol. 2014 Feb 11;63(5):430-3.
Long-term Low-Density Lipoprotein Cholesterol-Lowering Efficacy, Persistence, and Safety of Evolocumab in Treatment of Hypercholesterolemia: Results Up to 4 Years From the Open-Label OSLER-1 Extension Study. JAMA Cardiol. 2017 Jun 1;2(6):598-607.