Efficacy of alirocumab in high cardiovascular risk populations with or without heterozygous familial hypercholesterolemia: Pooled analysis of eight ODYSSEY Phase 3 clinical program trials.
Identifieur interne : 000160 ( Main/Exploration ); précédent : 000159; suivant : 000161Efficacy of alirocumab in high cardiovascular risk populations with or without heterozygous familial hypercholesterolemia: Pooled analysis of eight ODYSSEY Phase 3 clinical program trials.
Auteurs : Michel Farnier [France] ; Daniel Gaudet [Canada] ; Velichka Valcheva [France] ; Pascal Minini [France] ; Kathryn Miller [États-Unis] ; Bertrand Cariou [France]Source :
- International journal of cardiology [ 1874-1754 ] ; 2016.
Descripteurs français
- KwdFr :
- Anticorps monoclonaux (administration et posologie), Anticorps monoclonaux humanisés, Cholestérol (sang), Facteurs de risque, France (épidémiologie), Humains, Hyperlipoprotéinémie de type II (), Hyperlipoprotéinémie de type II (sang), Hyperlipoprotéinémie de type II (traitement médicamenteux), Hétérozygote, Incidence, Maladies cardiovasculaires (), Maladies cardiovasculaires (épidémiologie), Maladies cardiovasculaires (étiologie), Méthode en double aveugle, Québec (épidémiologie), Relation dose-effet des médicaments, États-Unis d'Amérique (épidémiologie), Évaluation des risques.
- MESH :
- administration et posologie : Anticorps monoclonaux.
- sang : Cholestérol, Hyperlipoprotéinémie de type II.
- traitement médicamenteux : Hyperlipoprotéinémie de type II.
- épidémiologie : France, Maladies cardiovasculaires, Québec, États-Unis d'Amérique.
- étiologie : Maladies cardiovasculaires.
- Anticorps monoclonaux humanisés, Facteurs de risque, Humains, Hyperlipoprotéinémie de type II, Hétérozygote, Incidence, Maladies cardiovasculaires, Méthode en double aveugle, Relation dose-effet des médicaments, Évaluation des risques.
- Wicri :
- geographic : France, États-Unis.
English descriptors
- KwdEn :
- Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal, Humanized, Cardiovascular Diseases (epidemiology), Cardiovascular Diseases (etiology), Cardiovascular Diseases (prevention & control), Cholesterol (blood), Dose-Response Relationship, Drug, Double-Blind Method, France (epidemiology), Heterozygote, Humans, Hyperlipoproteinemia Type II (blood), Hyperlipoproteinemia Type II (complications), Hyperlipoproteinemia Type II (drug therapy), Incidence, Quebec (epidemiology), Risk Assessment, Risk Factors, United States (epidemiology).
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal.
- chemical , blood : Cholesterol.
- chemical : Antibodies, Monoclonal, Humanized.
- geographic , epidemiology : France, Quebec, United States.
- blood : Hyperlipoproteinemia Type II.
- complications : Hyperlipoproteinemia Type II.
- drug therapy : Hyperlipoproteinemia Type II.
- epidemiology : Cardiovascular Diseases.
- etiology : Cardiovascular Diseases.
- prevention & control : Cardiovascular Diseases.
- Dose-Response Relationship, Drug, Double-Blind Method, Heterozygote, Humans, Incidence, Risk Assessment, Risk Factors.
Abstract
OBJECTIVES
Despite maximally tolerated statin therapy, many patients with high cardiovascular risk, with or without heterozygous familial hypercholesterolemia may require additional low-density lipoprotein cholesterol (LDL-C) reduction. We report pooled alirocumab (ALI) efficacy and safety data from eight Phase 3 trials in 4629 hypercholesterolemia patients, receiving background statin therapy.
MATERIAL AND METHODS
Studies were pooled by ALI dose and control: ALI 75/150mg every 2weeks (Q2W; dose increased to 150mg Q2W at Week 12 based on Week 8 LDL-C) versus ezetimibe (EZE; Pool 1) or placebo (PBO; Pool 2), and ALI 150mg Q2W versus PBO (Pool 3).
RESULTS
Mean baseline LDL-C was 109 vs. 105mg/dL (Pool 1), 129 vs. 130mg/dL (Pool 2) and 126 vs. 125mg/dL (Pool 3). ALI 75/150mg Q2W reduced LDL-C by 48.9% (vs. -19.3% EZE) and 48.6% (vs. +4.2% PBO) from baseline to Week 24, and ALI 150mg Q2W reduced LDL-C by 60.4% (vs. +0.5% PBO; all p<0.0001). LDL-C reductions were sustained to Week 104. Risk-based LDL-C goals (<70mg/dL or <100mg/dL) were achieved by 78.0%, 75.2%, and 79.0% (Pool 1-3) of ALI-treated patients (vs. 52.4%, 6.4%, and 8.4%, respectively, for controls) at Week 24. Consistent reductions were observed in apolipoprotein B, non-high-density lipoprotein cholesterol, and lipoprotein (a) (p<0.0001 vs. control). Common adverse events in ALI-treated patients were nasopharyngitis, injection-site reactions, upper respiratory tract infections, and influenza.
CONCLUSIONS
Alirocumab treatment significantly reduced LDL-C in high cardiovascular risk patients, enabling most to achieve risk-based LDL-C goals.
DOI: 10.1016/j.ijcard.2016.08.273
PubMed: 27573600
Affiliations:
- Canada, France, États-Unis
- Bourgogne, Bourgogne-Franche-Comté, Pays de la Loire, État de New York, Île-de-France
- Dijon, Nantes, Paris
Links toward previous steps (curation, corpus...)
Le document en format XML
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(épidémiologie)</term><term>Maladies cardiovasculaires (étiologie)</term><term>Méthode en double aveugle</term><term>Québec (épidémiologie)</term><term>Relation dose-effet des médicaments</term><term>États-Unis d'Amérique (épidémiologie)</term><term>Évaluation des risques</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Cholesterol</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>France</term><term>Quebec</term><term>United States</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux</term></keywords><keywords scheme="MESH" qualifier="blood" 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type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>Despite maximally tolerated statin therapy, many patients with high cardiovascular risk, with or without heterozygous familial hypercholesterolemia may require additional low-density lipoprotein cholesterol (LDL-C) reduction. We report pooled alirocumab (ALI) efficacy and safety data from eight Phase 3 trials in 4629 hypercholesterolemia patients, receiving background statin therapy.</p></div><div type="abstract" xml:lang="en"><p><b>MATERIAL AND METHODS</b></p><p>Studies were pooled by ALI dose and control: ALI 75/150mg every 2weeks (Q2W; dose increased to 150mg Q2W at Week 12 based on Week 8 LDL-C) versus ezetimibe (EZE; Pool 1) or placebo (PBO; Pool 2), and ALI 150mg Q2W versus PBO (Pool 3).</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Mean baseline LDL-C was 109 vs. 105mg/dL (Pool 1), 129 vs. 130mg/dL (Pool 2) and 126 vs. 125mg/dL (Pool 3). ALI 75/150mg Q2W reduced LDL-C by 48.9% (vs. -19.3% EZE) and 48.6% (vs. +4.2% PBO) from baseline to Week 24, and ALI 150mg Q2W reduced LDL-C by 60.4% (vs. +0.5% PBO; all p<0.0001). LDL-C reductions were sustained to Week 104. Risk-based LDL-C goals (<70mg/dL or <100mg/dL) were achieved by 78.0%, 75.2%, and 79.0% (Pool 1-3) of ALI-treated patients (vs. 52.4%, 6.4%, and 8.4%, respectively, for controls) at Week 24. Consistent reductions were observed in apolipoprotein B, non-high-density lipoprotein cholesterol, and lipoprotein (a) (p<0.0001 vs. control). Common adverse events in ALI-treated patients were nasopharyngitis, injection-site reactions, upper respiratory tract infections, and influenza.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Alirocumab treatment significantly reduced LDL-C in high cardiovascular risk patients, enabling most to achieve risk-based LDL-C goals.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27573600</PMID><DateCompleted><Year>2017</Year><Month>10</Month><Day>12</Day></DateCompleted><DateRevised><Year>2019</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1874-1754</ISSN><JournalIssue CitedMedium="Internet"><Volume>223</Volume><PubDate><Year>2016</Year><Month>Nov</Month><Day>15</Day></PubDate></JournalIssue><Title>International journal of cardiology</Title><ISOAbbreviation>Int. J. Cardiol.</ISOAbbreviation></Journal><ArticleTitle>Efficacy of alirocumab in high cardiovascular risk populations with or without heterozygous familial hypercholesterolemia: Pooled analysis of eight ODYSSEY Phase 3 clinical program trials.</ArticleTitle><Pagination><MedlinePgn>750-757</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0167-5273(16)31980-5</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ijcard.2016.08.273</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">Despite maximally tolerated statin therapy, many patients with high cardiovascular risk, with or without heterozygous familial hypercholesterolemia may require additional low-density lipoprotein cholesterol (LDL-C) reduction. We report pooled alirocumab (ALI) efficacy and safety data from eight Phase 3 trials in 4629 hypercholesterolemia patients, receiving background statin therapy.</AbstractText><AbstractText Label="MATERIAL AND METHODS" NlmCategory="METHODS">Studies were pooled by ALI dose and control: ALI 75/150mg every 2weeks (Q2W; dose increased to 150mg Q2W at Week 12 based on Week 8 LDL-C) versus ezetimibe (EZE; Pool 1) or placebo (PBO; Pool 2), and ALI 150mg Q2W versus PBO (Pool 3).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Mean baseline LDL-C was 109 vs. 105mg/dL (Pool 1), 129 vs. 130mg/dL (Pool 2) and 126 vs. 125mg/dL (Pool 3). ALI 75/150mg Q2W reduced LDL-C by 48.9% (vs. -19.3% EZE) and 48.6% (vs. +4.2% PBO) from baseline to Week 24, and ALI 150mg Q2W reduced LDL-C by 60.4% (vs. +0.5% PBO; all p<0.0001). LDL-C reductions were sustained to Week 104. Risk-based LDL-C goals (<70mg/dL or <100mg/dL) were achieved by 78.0%, 75.2%, and 79.0% (Pool 1-3) of ALI-treated patients (vs. 52.4%, 6.4%, and 8.4%, respectively, for controls) at Week 24. Consistent reductions were observed in apolipoprotein B, non-high-density lipoprotein cholesterol, and lipoprotein (a) (p<0.0001 vs. control). Common adverse events in ALI-treated patients were nasopharyngitis, injection-site reactions, upper respiratory tract infections, and influenza.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Alirocumab treatment significantly reduced LDL-C in high cardiovascular risk patients, enabling most to achieve risk-based LDL-C goals.</AbstractText><CopyrightInformation>Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Farnier</LastName><ForeName>Michel</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Lipid Clinic, Point Médical, Dijon, France. Electronic address: michelfarnier@nerim.net.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gaudet</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Lipidology Unit, Community Genomic Medicine Center, Department of Medicine, Université de Montréal and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Valcheva</LastName><ForeName>Velichka</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Global Medical Affairs, Sanofi, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Minini</LastName><ForeName>Pascal</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Biostatistics and Programming, Sanofi, Chilly-Mazarin, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Miller</LastName><ForeName>Kathryn</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Biostatistics and Data Management, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cariou</LastName><ForeName>Bertrand</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Endocrinology, l'Institut du Thorax, Nantes University Hospital, Nantes, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>08</Month><Day>18</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Int J Cardiol</MedlineTA><NlmUniqueID>8200291</NlmUniqueID><ISSNLinking>0167-5273</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>97C5T2UQ7J</RegistryNumber><NameOfSubstance UI="D002784">Cholesterol</NameOfSubstance></Chemical><Chemical><RegistryNumber>PP0SHH6V16</RegistryNumber><NameOfSubstance UI="C571059">alirocumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002318" MajorTopicYN="N">Cardiovascular Diseases</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000209" MajorTopicYN="Y">etiology</QualifierName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002784" MajorTopicYN="N">Cholesterol</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005602" MajorTopicYN="N" Type="Geographic">France</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName 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Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Alirocumab</Keyword><Keyword MajorTopicYN="N">Hypercholesterolemia</Keyword><Keyword MajorTopicYN="N">Low-density lipoprotein cholesterol</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>06</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>08</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>8</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>10</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>8</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27573600</ArticleId><ArticleId IdType="pii">S0167-5273(16)31980-5</ArticleId><ArticleId IdType="doi">10.1016/j.ijcard.2016.08.273</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li><li>France</li><li>États-Unis</li></country><region><li>Bourgogne</li><li>Bourgogne-Franche-Comté</li><li>Pays de la Loire</li><li>État de New York</li><li>Île-de-France</li></region><settlement><li>Dijon</li><li>Nantes</li><li>Paris</li></settlement></list><tree><country name="France"><region name="Bourgogne-Franche-Comté"><name sortKey="Farnier, Michel" sort="Farnier, Michel" uniqKey="Farnier M" first="Michel" last="Farnier">Michel Farnier</name></region><name sortKey="Cariou, Bertrand" sort="Cariou, Bertrand" uniqKey="Cariou B" first="Bertrand" last="Cariou">Bertrand Cariou</name><name sortKey="Minini, Pascal" sort="Minini, Pascal" uniqKey="Minini P" first="Pascal" last="Minini">Pascal Minini</name><name sortKey="Valcheva, Velichka" sort="Valcheva, Velichka" uniqKey="Valcheva V" first="Velichka" last="Valcheva">Velichka Valcheva</name></country><country name="Canada"><noRegion><name sortKey="Gaudet, Daniel" sort="Gaudet, Daniel" uniqKey="Gaudet D" first="Daniel" last="Gaudet">Daniel Gaudet</name></noRegion></country><country name="États-Unis"><region name="État de New York"><name sortKey="Miller, Kathryn" sort="Miller, Kathryn" uniqKey="Miller K" first="Kathryn" last="Miller">Kathryn Miller</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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