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A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
by
Blom, Dirk J
, Lillestol, Michael J
, Monsalvo, Maria Laura
, Roth, Eli
, Bolognese, Michael
, Kim, Jae B
, Burgess, Lesley
, Ceska, Richard
, Ballantyne, Christie M
, Toth, Phillip D
, Tsirtsonis, Kate
, Koren, Michael J
, Hala, Tomas
, Scott, Rob
, Stein, Evan A
, Wasserman, Scott M
in
Adult
/ Aged
/ Antibodies, Monoclonal - adverse effects
/ Antibodies, Monoclonal - therapeutic use
/ Apolipoprotein B
/ Atorvastatin
/ Atorvastatin Calcium
/ Azetidines - therapeutic use
/ Biological and medical sciences
/ Cholesterol
/ Cholesterol, LDL - blood
/ Clinical trials
/ Combined Modality Therapy
/ Diet
/ Disorders of blood lipids. Hyperlipoproteinemia
/ Double-Blind Method
/ Drug therapy
/ Ezetimibe
/ Female
/ General aspects
/ Heptanoic Acids - therapeutic use
/ Humans
/ Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
/ Hyperlipidemia
/ Hyperlipidemias - diet therapy
/ Hyperlipidemias - drug therapy
/ Influenza
/ Kexin
/ Least-Squares Analysis
/ Low density lipoprotein
/ Male
/ Medical sciences
/ Metabolic diseases
/ Middle Aged
/ Monoclonal antibodies
/ Nutrient deficiency
/ Pain
/ Patients
/ Proprotein Convertase 9
/ Proprotein convertases
/ Proprotein Convertases - antagonists & inhibitors
/ Proprotein Convertases - immunology
/ Pyrroles - therapeutic use
/ Respiratory tract diseases
/ Rhinopharyngitis
/ Serine Endopeptidases - immunology
/ Subtilisin
/ Triglycerides
/ Ultracentrifugation
2014
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A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
by
Blom, Dirk J
, Lillestol, Michael J
, Monsalvo, Maria Laura
, Roth, Eli
, Bolognese, Michael
, Kim, Jae B
, Burgess, Lesley
, Ceska, Richard
, Ballantyne, Christie M
, Toth, Phillip D
, Tsirtsonis, Kate
, Koren, Michael J
, Hala, Tomas
, Scott, Rob
, Stein, Evan A
, Wasserman, Scott M
in
Adult
/ Aged
/ Antibodies, Monoclonal - adverse effects
/ Antibodies, Monoclonal - therapeutic use
/ Apolipoprotein B
/ Atorvastatin
/ Atorvastatin Calcium
/ Azetidines - therapeutic use
/ Biological and medical sciences
/ Cholesterol
/ Cholesterol, LDL - blood
/ Clinical trials
/ Combined Modality Therapy
/ Diet
/ Disorders of blood lipids. Hyperlipoproteinemia
/ Double-Blind Method
/ Drug therapy
/ Ezetimibe
/ Female
/ General aspects
/ Heptanoic Acids - therapeutic use
/ Humans
/ Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
/ Hyperlipidemia
/ Hyperlipidemias - diet therapy
/ Hyperlipidemias - drug therapy
/ Influenza
/ Kexin
/ Least-Squares Analysis
/ Low density lipoprotein
/ Male
/ Medical sciences
/ Metabolic diseases
/ Middle Aged
/ Monoclonal antibodies
/ Nutrient deficiency
/ Pain
/ Patients
/ Proprotein Convertase 9
/ Proprotein convertases
/ Proprotein Convertases - antagonists & inhibitors
/ Proprotein Convertases - immunology
/ Pyrroles - therapeutic use
/ Respiratory tract diseases
/ Rhinopharyngitis
/ Serine Endopeptidases - immunology
/ Subtilisin
/ Triglycerides
/ Ultracentrifugation
2014
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A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
by
Blom, Dirk J
, Lillestol, Michael J
, Monsalvo, Maria Laura
, Roth, Eli
, Bolognese, Michael
, Kim, Jae B
, Burgess, Lesley
, Ceska, Richard
, Ballantyne, Christie M
, Toth, Phillip D
, Tsirtsonis, Kate
, Koren, Michael J
, Hala, Tomas
, Scott, Rob
, Stein, Evan A
, Wasserman, Scott M
in
Adult
/ Aged
/ Antibodies, Monoclonal - adverse effects
/ Antibodies, Monoclonal - therapeutic use
/ Apolipoprotein B
/ Atorvastatin
/ Atorvastatin Calcium
/ Azetidines - therapeutic use
/ Biological and medical sciences
/ Cholesterol
/ Cholesterol, LDL - blood
/ Clinical trials
/ Combined Modality Therapy
/ Diet
/ Disorders of blood lipids. Hyperlipoproteinemia
/ Double-Blind Method
/ Drug therapy
/ Ezetimibe
/ Female
/ General aspects
/ Heptanoic Acids - therapeutic use
/ Humans
/ Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
/ Hyperlipidemia
/ Hyperlipidemias - diet therapy
/ Hyperlipidemias - drug therapy
/ Influenza
/ Kexin
/ Least-Squares Analysis
/ Low density lipoprotein
/ Male
/ Medical sciences
/ Metabolic diseases
/ Middle Aged
/ Monoclonal antibodies
/ Nutrient deficiency
/ Pain
/ Patients
/ Proprotein Convertase 9
/ Proprotein convertases
/ Proprotein Convertases - antagonists & inhibitors
/ Proprotein Convertases - immunology
/ Pyrroles - therapeutic use
/ Respiratory tract diseases
/ Rhinopharyngitis
/ Serine Endopeptidases - immunology
/ Subtilisin
/ Triglycerides
/ Ultracentrifugation
2014
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A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
Journal Article
A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
2014
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Overview
Patients with hyperlipidemia were assigned to receive the PCSK9 antibody evolocumab or placebo on a background of lipid-lowering therapy. At 52 weeks, the least-squares mean reduction in LDL cholesterol from baseline for evolocumab versus placebo was 57%.
Proprotein convertase subtilisin/kexin type 9 (PCSK9), a serine protease that is produced predominantly in the liver, is secreted into the plasma and plays a major role in regulating levels of low-density lipoprotein (LDL) cholesterol by binding to hepatic LDL receptors and promoting their degradation.
1
,
2
In short-term (8-to-12-week), placebo-controlled, phase 2 trials, PCSK9 inhibitors have been shown to significantly reduce LDL cholesterol levels.
3
–
9
Four of these trials involved the use of evolocumab (AMG 145), a fully human monoclonal PCSK9 antibody, and assessed different doses and regimens in diverse patient populations with varying lipid phenotypes, cardiovascular disease risks, and baseline . . .
Publisher
Massachusetts Medical Society
Subject
/ Aged
/ Antibodies, Monoclonal - adverse effects
/ Antibodies, Monoclonal - therapeutic use
/ Azetidines - therapeutic use
/ Biological and medical sciences
/ Diet
/ Disorders of blood lipids. Hyperlipoproteinemia
/ Female
/ Heptanoic Acids - therapeutic use
/ Humans
/ Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
/ Hyperlipidemias - diet therapy
/ Hyperlipidemias - drug therapy
/ Kexin
/ Male
/ Pain
/ Patients
/ Proprotein Convertases - antagonists & inhibitors
/ Proprotein Convertases - immunology
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