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Effect of a Monoclonal Antibody to PCSK9 on Low-Density Lipoprotein Cholesterol Levels in Statin-Intolerant Patients

Effect of a Monoclonal Antibody to PCSK9 on Low-Density Lipoprotein Cholesterol Levels in... PRELIMINARY COMMUNICATION ONLINE FIRST Effect of a Monoclonal Antibody to PCSK9 on Low-Density Lipoprotein Cholesterol Levels in Statin-Intolerant Patients The GAUSS Randomized Trial David Sullivan, MD Context An estimated 10% to 20% of patients cannot tolerate statins or adequate doses to achieve treatment goals. Plasma proprotein convertase subtilisin/kexin type Anders G. Olsson, MD, PhD 9 (PCSK9) binds to low-density lipoprotein (LDL) receptors, promoting their degra- Rob Scott, MD dation and increasing LDL cholesterol levels. In phase 1 studies, a human monoclonal antibody to PCSK9, AMG145, was well tolerated and reduced LDL cholesterol levels. Jae B. Kim, MD Objective To assess the efficacy and tolerability of AMG145 in patients with statin Allen Xue, PhD intolerance due to muscle-related side effects. Val Gebski, MStat Design, Setting, and Patients A 12-week, randomized, double-blind, placebo- Scott M. Wasserman, MD and ezetimibe-controlled, dose-ranging study conducted between July 2011 and May Evan A. Stein, MD, PhD 2012 in statin-intolerant adult patients at 33 international sites. Intervention Patients were randomized equally to 1 of 5 groups: AMG145 alone at doses of 280 mg, 350 mg, or 420 mg; AMG145 at 420 mg plus 10 mg of ezetimibe; EDUCTION OF LOW-DENSITY LI- or 10 mg of ezetimibe http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Effect of a Monoclonal Antibody to PCSK9 on Low-Density Lipoprotein Cholesterol Levels in Statin-Intolerant Patients

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Publisher
American Medical Association
Copyright
Copyright 2012 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.25790
pmid
23128163
Publisher site
See Article on Publisher Site

Abstract

PRELIMINARY COMMUNICATION ONLINE FIRST Effect of a Monoclonal Antibody to PCSK9 on Low-Density Lipoprotein Cholesterol Levels in Statin-Intolerant Patients The GAUSS Randomized Trial David Sullivan, MD Context An estimated 10% to 20% of patients cannot tolerate statins or adequate doses to achieve treatment goals. Plasma proprotein convertase subtilisin/kexin type Anders G. Olsson, MD, PhD 9 (PCSK9) binds to low-density lipoprotein (LDL) receptors, promoting their degra- Rob Scott, MD dation and increasing LDL cholesterol levels. In phase 1 studies, a human monoclonal antibody to PCSK9, AMG145, was well tolerated and reduced LDL cholesterol levels. Jae B. Kim, MD Objective To assess the efficacy and tolerability of AMG145 in patients with statin Allen Xue, PhD intolerance due to muscle-related side effects. Val Gebski, MStat Design, Setting, and Patients A 12-week, randomized, double-blind, placebo- Scott M. Wasserman, MD and ezetimibe-controlled, dose-ranging study conducted between July 2011 and May Evan A. Stein, MD, PhD 2012 in statin-intolerant adult patients at 33 international sites. Intervention Patients were randomized equally to 1 of 5 groups: AMG145 alone at doses of 280 mg, 350 mg, or 420 mg; AMG145 at 420 mg plus 10 mg of ezetimibe; EDUCTION OF LOW-DENSITY LI- or 10 mg of ezetimibe

Journal

JAMAAmerican Medical Association

Published: Dec 19, 2012

References