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monoclonal antibody AMG 145

Indications: - dyslipidemia, with increased LDL cholesterol - may be used with statin Mechanism of action: - inhibits PCSK9 - decreases LDL cholesterol (50%)

Interactions

drug adverse effects of anti-hyperlipidemic agents

General

PCSK9 inhibitor (ALN-PCS) pharmaceutical monoclonal antibody

References

  1. Giugliano RP et al 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 The Lancet, Early Online Publication, 6 November 2012 PMID: 23141813 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61770-X/abstract - Koren MJ et al Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study The Lancet, Early Online Publication, 6 November 2012 PMID: 23141812 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61771-1/abstract - Tonkin AM and Watts GF Into the future: diversifying lipid management The Lancet, Early Online Publication, 6 November 2012 PMID: 23141810 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61888-1/fulltext
  2. Raal F et al Low-Density Lipoprotein Cholesterol-Lowering Effects of AMG 145, a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease in Patients With Heterozygous Familial Hypercholesterolemia: The Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) Randomized Trial. Circulation. 2012 Nov 5. [Epub ahead of print] PMID: 23129602
  3. Sullivan D et al Effect of a Monoclonal Antibody to PCSK9 on Low-Density Lipoprotein Cholesterol Levels in Statin-Intolerant Patients: The GAUSS Randomized Trial. JAMA. 2012 Nov 5:1-10 PMID: 23128163