AustralieFrV1, Main, Exploration, bibRecord, 003195

Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial

Identifieur interne : 003195 ( Main/Exploration ); précédent : 003194; suivant : 003196

Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial

Auteurs : Harold Bays ; Daniel Gaudet ; Robert Weiss ; Juan Lima Ruiz ; Gerald F. Watts ; Ioanna Gouni-Berthold ; Jennifer Robinson ; Jian Zhao ; Corinne Hanotin ; Stephen Donahue

Source :

The Journal of Clinical Endocrinology and Metabolism [ 0021-972X ] ; 2015.

RBID : PMC:4524987

Descripteurs français

English descriptors

KwdEn :
- Aged, Antibodies (blood), Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal (adverse effects), Antibodies, Monoclonal (immunology), Anticholesteremic Agents (administration & dosage), Anticholesteremic Agents (adverse effects), Anticholesteremic Agents (immunology), Atorvastatin Calcium, Azetidines (administration & dosage), Azetidines (adverse effects), Azetidines (immunology), Cardiovascular Diseases (blood), Cardiovascular Diseases (prevention & control), Cholesterol, LDL (blood), Drug Therapy, Combination, Ezetimibe, Female, Heptanoic Acids (administration & dosage), Heptanoic Acids (adverse effects), Heptanoic Acids (immunology), Humans, Male, Middle Aged, Pyrroles (administration & dosage), Pyrroles (adverse effects), Pyrroles (immunology), Treatment Outcome.
MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Anticholesteremic Agents, Azetidines, Heptanoic Acids, Pyrroles.
- chemical , adverse effects : Antibodies, Monoclonal, Anticholesteremic Agents, Azetidines, Heptanoic Acids, Pyrroles.
- chemical , blood : Antibodies, Cholesterol, LDL.
- chemical , immunology : Antibodies, Monoclonal, Anticholesteremic Agents, Azetidines, Heptanoic Acids, Pyrroles.
- blood : Cardiovascular Diseases.
- prevention & control : Cardiovascular Diseases.
- Aged, Atorvastatin Calcium, Drug Therapy, Combination, Ezetimibe, Female, Humans, Male, Middle Aged, Treatment Outcome.

Abstract

Context:

Despite current standard of care, many patients at high risk of cardiovascular disease (CVD) still have elevated low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9.

Objective:

The objective of the study was to compare the LDL-C-lowering efficacy of adding alirocumab vs other common lipid-lowering strategies.

Design, Patients, and Interventions:

Patients (n = 355) with very high CVD risk and LDL-C levels of 70 mg/dL or greater or high CVD risk and LDL-C of 100 mg/dL or greater on baseline atorvastatin 20 or 40 mg were randomized to one of the following: 1) add-on alirocumab 75 mg every 2 weeks (Q2W) sc; 2) add-on ezetimibe 10 mg/d; 3) double atorvastatin dose; or 4) for atorvastatin 40 mg regimen only, switch to rosuvastatin 40 mg. For patients not achieving protocol-defined LDL-C goals, the alirocumab dose was increased (blinded) at week 12 to 150 mg Q2W.

Main Outcome Measure:

The primary end point was percentage change in calculated LDL-C from baseline to 24 weeks (intent to treat).

Results:

Among atorvastatin 20 and 40 mg regimens, respectively, add-on alirocumab reduced LDL-C levels by 44.1% and 54.0% (P < .001 vs all comparators); add-on ezetimibe, 20.5% and 22.6%; doubling of atorvastatin dose, 5.0% and 4.8%; and switching atorvastatin 40 mg to rosuvastatin 40 mg, 21.4%. Most alirocumab-treated patients (87.2% and 84.6%) achieved their LDL-C goals. Most alirocumab-treated patients (86%) maintained their 75-mg Q2W regimen. Treatment-emergent adverse events occurred in 65.4% of alirocumab patients vs 64.4% ezetimibe and 63.8% double atorvastatin/switch to rosuvastatin (data were pooled).

Conclusions:

Adding alirocumab to atorvastatin provided significantly greater LDL-C reductions vs adding ezetimibe, doubling atorvastatin dose, or switching to rosuvastatin and enabled greater LDL-C goal achievement.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4524987

DOI: 10.1210/jc.2015-1520
PubMed: 26030325
PubMed Central: 4524987

Affiliations:

Le document en format XML

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<author><name sortKey="Gouni Berthold, Ioanna" sort="Gouni Berthold, Ioanna" uniqKey="Gouni Berthold I" first="Ioanna" last="Gouni-Berthold">Ioanna Gouni-Berthold</name>
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<term>Antibodies (blood)</term>
<term>Antibodies, Monoclonal (administration & dosage)</term>
<term>Antibodies, Monoclonal (adverse effects)</term>
<term>Antibodies, Monoclonal (immunology)</term>
<term>Anticholesteremic Agents (administration & dosage)</term>
<term>Anticholesteremic Agents (adverse effects)</term>
<term>Anticholesteremic Agents (immunology)</term>
<term>Atorvastatin Calcium</term>
<term>Azetidines (administration & dosage)</term>
<term>Azetidines (adverse effects)</term>
<term>Azetidines (immunology)</term>
<term>Cardiovascular Diseases (blood)</term>
<term>Cardiovascular Diseases (prevention & control)</term>
<term>Cholesterol, LDL (blood)</term>
<term>Drug Therapy, Combination</term>
<term>Ezetimibe</term>
<term>Female</term>
<term>Heptanoic Acids (administration & dosage)</term>
<term>Heptanoic Acids (adverse effects)</term>
<term>Heptanoic Acids (immunology)</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Pyrroles (administration & dosage)</term>
<term>Pyrroles (adverse effects)</term>
<term>Pyrroles (immunology)</term>
<term>Treatment Outcome</term>
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<term>Acides heptanoïques (effets indésirables)</term>
<term>Acides heptanoïques (immunologie)</term>
<term>Adulte d'âge moyen</term>
<term>Anticholestérolémiants (administration et posologie)</term>
<term>Anticholestérolémiants (effets indésirables)</term>
<term>Anticholestérolémiants (immunologie)</term>
<term>Anticorps (sang)</term>
<term>Anticorps monoclonaux (administration et posologie)</term>
<term>Anticorps monoclonaux (effets indésirables)</term>
<term>Anticorps monoclonaux (immunologie)</term>
<term>Association de médicaments</term>
<term>Atorvastatine de calcium</term>
<term>Azétidines (administration et posologie)</term>
<term>Azétidines (effets indésirables)</term>
<term>Azétidines (immunologie)</term>
<term>Cholestérol LDL (sang)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Maladies cardiovasculaires ()</term>
<term>Maladies cardiovasculaires (sang)</term>
<term>Mâle</term>
<term>Pyrroles (administration et posologie)</term>
<term>Pyrroles (effets indésirables)</term>
<term>Pyrroles (immunologie)</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Ézétimibe</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Anticholesteremic Agents</term>
<term>Azetidines</term>
<term>Heptanoic Acids</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Anticholesteremic Agents</term>
<term>Azetidines</term>
<term>Heptanoic Acids</term>
<term>Pyrroles</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies</term>
<term>Cholesterol, LDL</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Anticholesteremic Agents</term>
<term>Azetidines</term>
<term>Heptanoic Acids</term>
<term>Pyrroles</term>
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<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Acides heptanoïques</term>
<term>Anticholestérolémiants</term>
<term>Anticorps monoclonaux</term>
<term>Azétidines</term>
<term>Pyrroles</term>
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<keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Cardiovascular Diseases</term>
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<term>Anticholestérolémiants</term>
<term>Anticorps monoclonaux</term>
<term>Azétidines</term>
<term>Pyrroles</term>
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<term>Anticorps monoclonaux</term>
<term>Azétidines</term>
<term>Pyrroles</term>
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<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Cardiovascular Diseases</term>
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<keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps</term>
<term>Cholestérol LDL</term>
<term>Maladies cardiovasculaires</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Atorvastatin Calcium</term>
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<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Treatment Outcome</term>
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<term>Association de médicaments</term>
<term>Atorvastatine de calcium</term>
<term>Femelle</term>
<term>Humains</term>
<term>Maladies cardiovasculaires</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Context:</title>
<p>Despite current standard of care, many patients at high risk of cardiovascular disease (CVD) still have elevated low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9.</p>
</sec>
<sec><title>Objective:</title>
<p>The objective of the study was to compare the LDL-C-lowering efficacy of adding alirocumab vs other common lipid-lowering strategies.</p>
</sec>
<sec><title>Design, Patients, and Interventions:</title>
<p>Patients (n = 355) with very high CVD risk and LDL-C levels of 70 mg/dL or greater or high CVD risk and LDL-C of 100 mg/dL or greater on baseline atorvastatin 20 or 40 mg were randomized to one of the following: 1) add-on alirocumab 75 mg every 2 weeks (Q2W) sc; 2) add-on ezetimibe 10 mg/d; 3) double atorvastatin dose; or 4) for atorvastatin 40 mg regimen only, switch to rosuvastatin 40 mg. For patients not achieving protocol-defined LDL-C goals, the alirocumab dose was increased (blinded) at week 12 to 150 mg Q2W.</p>
</sec>
<sec><title>Main Outcome Measure:</title>
<p>The primary end point was percentage change in calculated LDL-C from baseline to 24 weeks (intent to treat).</p>
</sec>
<sec><title>Results:</title>
<p>Among atorvastatin 20 and 40 mg regimens, respectively, add-on alirocumab reduced LDL-C levels by 44.1% and 54.0% (<italic>P</italic>
 < .001 vs all comparators); add-on ezetimibe, 20.5% and 22.6%; doubling of atorvastatin dose, 5.0% and 4.8%; and switching atorvastatin 40 mg to rosuvastatin 40 mg, 21.4%. Most alirocumab-treated patients (87.2% and 84.6%) achieved their LDL-C goals. Most alirocumab-treated patients (86%) maintained their 75-mg Q2W regimen. Treatment-emergent adverse events occurred in 65.4% of alirocumab patients vs 64.4% ezetimibe and 63.8% double atorvastatin/switch to rosuvastatin (data were pooled).</p>
</sec>
<sec><title>Conclusions:</title>
<p>Adding alirocumab to atorvastatin provided significantly greater LDL-C reductions vs adding ezetimibe, doubling atorvastatin dose, or switching to rosuvastatin and enabled greater LDL-C goal achievement.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list></list>
<tree><noCountry><name sortKey="Bays, Harold" sort="Bays, Harold" uniqKey="Bays H" first="Harold" last="Bays">Harold Bays</name>
<name sortKey="Donahue, Stephen" sort="Donahue, Stephen" uniqKey="Donahue S" first="Stephen" last="Donahue">Stephen Donahue</name>
<name sortKey="Gaudet, Daniel" sort="Gaudet, Daniel" uniqKey="Gaudet D" first="Daniel" last="Gaudet">Daniel Gaudet</name>
<name sortKey="Gouni Berthold, Ioanna" sort="Gouni Berthold, Ioanna" uniqKey="Gouni Berthold I" first="Ioanna" last="Gouni-Berthold">Ioanna Gouni-Berthold</name>
<name sortKey="Hanotin, Corinne" sort="Hanotin, Corinne" uniqKey="Hanotin C" first="Corinne" last="Hanotin">Corinne Hanotin</name>
<name sortKey="Robinson, Jennifer" sort="Robinson, Jennifer" uniqKey="Robinson J" first="Jennifer" last="Robinson">Jennifer Robinson</name>
<name sortKey="Ruiz, Juan Lima" sort="Ruiz, Juan Lima" uniqKey="Ruiz J" first="Juan Lima" last="Ruiz">Juan Lima Ruiz</name>
<name sortKey="Watts, Gerald F" sort="Watts, Gerald F" uniqKey="Watts G" first="Gerald F." last="Watts">Gerald F. Watts</name>
<name sortKey="Weiss, Robert" sort="Weiss, Robert" uniqKey="Weiss R" first="Robert" last="Weiss">Robert Weiss</name>
<name sortKey="Zhao, Jian" sort="Zhao, Jian" uniqKey="Zhao J" first="Jian" last="Zhao">Jian Zhao</name>
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Serveur d'exploration sur les relations entre la France et l'Australie

Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial

Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki

	Serveur d'exploration sur les relations entre la France et l'Australie
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