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
LAPLACE-TIMI 57 Primary Results (AHA 2012)
TIMI 57 Slides
Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2012;35(7):385-91.
Low-Density Lipoprotein Lowering in 2013 by Nonstatin Agents: The Discovery and Development of Promising Novel Targeted Therapies. J Cardiovasc Pharmacol Ther. 2013 May;18(3):199-210.
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.
Reduction in lipoprotein(a) with PCSK9 monoclonal antibody evolocumab (AMG 145): a pooled analysis of more than 1,300 patients in 4 phase II trials. J Am Coll Cardiol. 2014 Apr 8;63(13):1278-1288.
PCSK9 inhibition-mediated reduction in Lp(a) with evolocumab: an analysis of 10 clinical trials and the role of the LDL receptor. J Lipid Res. 2016 Jun;57(6):1086-96.
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.
PCSK9 inhibitors for treating dyslipidemia in patients at different cardiovascular risk: a systematic review and a meta-analysis. Intern Emerg Med. 2017 Oct;12(7):1043-1053.
Association Between Circulating Baseline Proprotein Convertase Subtilisin Kexin Type 9 Levels and Efficacy of Evolocumab. JAMA Cardiol. 2017 May 1;2(5):556-560.
Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543.