Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab.
Identifieur interne : 003596 ( PubMed/Curation ); précédent : 003595; suivant : 003597Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab.
Auteurs : Erik Stroes [Pays-Bas] ; David Colquhoun [Australie] ; David Sullivan [Australie] ; Fernando Civeira [Espagne] ; Robert S. Rosenson [États-Unis] ; Gerald F. Watts [Australie] ; Eric Bruckert [France] ; Leslie Cho [États-Unis] ; Ricardo Dent [États-Unis] ; Beat Knusel [États-Unis] ; Allen Xue [États-Unis] ; Rob Scott [États-Unis] ; Scott M. Wasserman [États-Unis] ; Michael Rocco [États-Unis]Source :
- Journal of the American College of Cardiology [ 1558-3597 ] ; 2014.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Anticorps monoclonaux (), Anticorps monoclonaux (administration et posologie), Anticorps monoclonaux (immunologie), Anticorps monoclonaux (sang), Apoptose, Association de médicaments, Calendrier d'administration des médicaments, Cholestérol (sang), Femelle, Humains, Hypercholestérolémie (immunologie), Hypercholestérolémie (sang), Hypercholestérolémie (traitement médicamenteux), Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase (administration et posologie), Jeune adulte, Mâle, Méthode en double aveugle, Proprotein convertases (antagonistes et inhibiteurs), Proprotein convertases (immunologie), Proprotéine convertase 9, Résultat thérapeutique, Serine endopeptidases (immunologie), Sujet âgé, Tolérance aux médicaments, Études de suivi.
- MESH :
- administration et posologie : Anticorps monoclonaux, Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase.
- antagonistes et inhibiteurs : Proprotein convertases.
- immunologie : Anticorps monoclonaux, Hypercholestérolémie, Proprotein convertases, Serine endopeptidases.
- sang : Anticorps monoclonaux, Cholestérol, Hypercholestérolémie.
- traitement médicamenteux : Hypercholestérolémie.
- Adolescent, Adulte, Anticorps monoclonaux, Apoptose, Association de médicaments, Calendrier d'administration des médicaments, Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Proprotéine convertase 9, Résultat thérapeutique, Sujet âgé, Tolérance aux médicaments, Études de suivi.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal (blood), Antibodies, Monoclonal (drug effects), Antibodies, Monoclonal (immunology), Apoptosis, Cholesterol (blood), Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Drug Tolerance, Female, Follow-Up Studies, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage), Hypercholesterolemia (blood), Hypercholesterolemia (drug therapy), Hypercholesterolemia (immunology), Male, Proprotein Convertase 9, Proprotein Convertases (antagonists & inhibitors), Proprotein Convertases (immunology), Serine Endopeptidases (immunology), Treatment Outcome, Young Adult.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Hydroxymethylglutaryl-CoA Reductase Inhibitors.
- chemical , antagonists & inhibitors : Proprotein Convertases.
- chemical , blood : Antibodies, Monoclonal, Cholesterol.
- chemical , drug effects : Antibodies, Monoclonal.
- chemical , immunology : Antibodies, Monoclonal, Proprotein Convertases, Serine Endopeptidases.
- blood : Hypercholesterolemia.
- drug therapy : Hypercholesterolemia.
- immunology : Hypercholesterolemia.
- Adolescent, Adult, Aged, Apoptosis, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Drug Tolerance, Female, Follow-Up Studies, Humans, Male, Proprotein Convertase 9, Treatment Outcome, Young Adult.
Abstract
This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe in hypercholesterolemic patients who are unable to tolerate effective statin doses.
DOI: 10.1016/j.jacc.2014.03.019
PubMed: 24694531
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Electronic address: e.s.stroes@amc.uva.nl.</nlm:affiliation><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>Department of Vascular Medicine, Academic Medical Center, Amsterdam</wicri:regionArea></affiliation></author><author><name sortKey="Colquhoun, David" sort="Colquhoun, David" uniqKey="Colquhoun D" first="David" last="Colquhoun">David Colquhoun</name><affiliation wicri:level="1"><nlm:affiliation>Wesley Medical Centre, Auchenflower, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Wesley Medical Centre, Auchenflower</wicri:regionArea></affiliation></author><author><name sortKey="Sullivan, David" sort="Sullivan, David" uniqKey="Sullivan D" first="David" last="Sullivan">David Sullivan</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Biochemistry, Royal Prince Alfred Hospital, Camperdown, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Clinical Biochemistry, Royal Prince Alfred Hospital, Camperdown</wicri:regionArea></affiliation></author><author><name sortKey="Civeira, Fernando" sort="Civeira, Fernando" uniqKey="Civeira F" first="Fernando" last="Civeira">Fernando Civeira</name><affiliation wicri:level="1"><nlm:affiliation>Hospital Universitario Miguel Servet, Zaragoza, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Universitario Miguel Servet, Zaragoza</wicri:regionArea></affiliation></author><author><name sortKey="Rosenson, Robert S" sort="Rosenson, Robert S" uniqKey="Rosenson R" first="Robert S" last="Rosenson">Robert S. Rosenson</name><affiliation wicri:level="2"><nlm:affiliation>Cardiometabolic Disorders Department, Icahn School of Medicine at Mount Sinai, New York, New York.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Cardiometabolic Disorders Department, Icahn School of Medicine at Mount Sinai, New York</wicri:cityArea></affiliation></author><author><name sortKey="Watts, Gerald F" sort="Watts, Gerald F" uniqKey="Watts G" first="Gerald F" last="Watts">Gerald F. Watts</name><affiliation wicri:level="1"><nlm:affiliation>Lipid Disorders Clinic, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Lipid Disorders Clinic, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth</wicri:regionArea></affiliation></author><author><name sortKey="Bruckert, Eric" sort="Bruckert, Eric" uniqKey="Bruckert E" first="Eric" last="Bruckert">Eric Bruckert</name><affiliation wicri:level="1"><nlm:affiliation>Hopital Pitie-Salpetriere, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hopital Pitie-Salpetriere, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Cho, Leslie" sort="Cho, Leslie" uniqKey="Cho L" first="Leslie" last="Cho">Leslie Cho</name><affiliation wicri:level="2"><nlm:affiliation>Preventive Cardiology and Rehabilitation, Cleveland Clinic, Cleveland, Ohio.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Preventive Cardiology and Rehabilitation, Cleveland Clinic, Cleveland</wicri:cityArea></affiliation></author><author><name sortKey="Dent, Ricardo" sort="Dent, Ricardo" uniqKey="Dent R" first="Ricardo" last="Dent">Ricardo Dent</name><affiliation wicri:level="2"><nlm:affiliation>Amgen, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Knusel, Beat" sort="Knusel, Beat" uniqKey="Knusel B" first="Beat" last="Knusel">Beat Knusel</name><affiliation wicri:level="2"><nlm:affiliation>Amgen, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Xue, Allen" sort="Xue, Allen" uniqKey="Xue A" first="Allen" last="Xue">Allen Xue</name><affiliation wicri:level="2"><nlm:affiliation>Amgen, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Scott, Rob" sort="Scott, Rob" uniqKey="Scott R" first="Rob" last="Scott">Rob Scott</name><affiliation wicri:level="2"><nlm:affiliation>Amgen, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Wasserman, Scott M" sort="Wasserman, Scott M" uniqKey="Wasserman S" first="Scott M" last="Wasserman">Scott M. Wasserman</name><affiliation wicri:level="2"><nlm:affiliation>Amgen, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Rocco, Michael" sort="Rocco, Michael" uniqKey="Rocco M" first="Michael" last="Rocco">Michael Rocco</name><affiliation wicri:level="2"><nlm:affiliation>Cardiovascular Medicine Department, Cleveland Clinic, Cleveland, Ohio.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Cardiovascular Medicine Department, Cleveland Clinic, Cleveland</wicri:cityArea></affiliation></author></analytic><series><title level="j">Journal of the American College of Cardiology</title><idno type="eISSN">1558-3597</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Antibodies, Monoclonal (administration & dosage)</term><term>Antibodies, Monoclonal (blood)</term><term>Antibodies, Monoclonal (drug effects)</term><term>Antibodies, Monoclonal (immunology)</term><term>Apoptosis</term><term>Cholesterol (blood)</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Therapy, Combination</term><term>Drug Tolerance</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage)</term><term>Hypercholesterolemia (blood)</term><term>Hypercholesterolemia (drug therapy)</term><term>Hypercholesterolemia (immunology)</term><term>Male</term><term>Proprotein Convertase 9</term><term>Proprotein Convertases (antagonists & inhibitors)</term><term>Proprotein Convertases (immunology)</term><term>Serine Endopeptidases (immunology)</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Anticorps monoclonaux ()</term><term>Anticorps monoclonaux (administration et posologie)</term><term>Anticorps monoclonaux (immunologie)</term><term>Anticorps monoclonaux (sang)</term><term>Apoptose</term><term>Association de médicaments</term><term>Calendrier d'administration des médicaments</term><term>Cholestérol (sang)</term><term>Femelle</term><term>Humains</term><term>Hypercholestérolémie (immunologie)</term><term>Hypercholestérolémie (sang)</term><term>Hypercholestérolémie (traitement médicamenteux)</term><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase (administration et posologie)</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Proprotein convertases (antagonistes et inhibiteurs)</term><term>Proprotein convertases (immunologie)</term><term>Proprotéine convertase 9</term><term>Résultat thérapeutique</term><term>Serine endopeptidases (immunologie)</term><term>Sujet âgé</term><term>Tolérance aux médicaments</term><term>Études de suivi</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Proprotein Convertases</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Cholesterol</term></keywords><keywords scheme="MESH" type="chemical" qualifier="drug effects" xml:lang="en"><term>Antibodies, Monoclonal</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Proprotein Convertases</term><term>Serine Endopeptidases</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Proprotein convertases</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Hypercholesterolemia</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hypercholesterolemia</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Hypercholestérolémie</term><term>Proprotein convertases</term><term>Serine endopeptidases</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Hypercholesterolemia</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Cholestérol</term><term>Hypercholestérolémie</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hypercholestérolémie</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Apoptosis</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Therapy, Combination</term><term>Drug Tolerance</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Proprotein Convertase 9</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Anticorps monoclonaux</term><term>Apoptose</term><term>Association de médicaments</term><term>Calendrier d'administration des médicaments</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Proprotéine convertase 9</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Tolérance aux médicaments</term><term>Études de suivi</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe in hypercholesterolemic patients who are unable to tolerate effective statin doses.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24694531</PMID><DateCreated><Year>2014</Year><Month>06</Month><Day>13</Day></DateCreated><DateCompleted><Year>2014</Year><Month>08</Month><Day>28</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1558-3597</ISSN><JournalIssue CitedMedium="Internet"><Volume>63</Volume><Issue>23</Issue><PubDate><Year>2014</Year><Month>Jun</Month><Day>17</Day></PubDate></JournalIssue><Title>Journal of the American College of Cardiology</Title><ISOAbbreviation>J. Am. Coll. Cardiol.</ISOAbbreviation></Journal><ArticleTitle>Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab.</ArticleTitle><Pagination><MedlinePgn>2541-2548</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0735-1097(14)01728-8</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jacc.2014.03.019</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe in hypercholesterolemic patients who are unable to tolerate effective statin doses.</AbstractText><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Statin intolerance, which is predominantly due to muscle-related side effects, is reported in up to 10% to 20% of patients. Evolocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), demonstrated marked reductions in plasma low-density lipoprotein cholesterol (LDL-C) in a phase 2 study in statin-intolerant patients.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The GAUSS-2 (Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects) trial was a 12-week, double-blind study of randomized patients (2:2:1:1) to evolocumab 140 mg every two weeks (Q2W) or evolocumab 420 mg once monthly (QM) both with daily oral placebo or subcutaneous placebo Q2W or QM both with daily oral ezetimibe 10 mg. Co-primary endpoints were percent change from baseline in LDL-C at the mean of weeks 10 and 12, and at week 12.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Three hundred seven patients (age 62 ± 10 years; LDL-C 193 ± 59 mg/dl) were randomized. Evolocumab reduced LDL-C from baseline by 53% to 56%, corresponding to treatment differences versus ezetimibe of 37% to 39% (p <0.001). Muscle adverse events occurred in 12% of evolocumab-treated patients and 23% of ezetimibe-treated patients. Treatment-emergent adverse events and laboratory abnormalities were comparable across treatment groups.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Robust efficacy combined with favorable tolerability makes evolocumab a promising therapy for addressing the largely unmet clinical need in high-risk patients with elevated cholesterol who are statin intolerant. (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2; NCT01763905).</AbstractText><CopyrightInformation>Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Stroes</LastName><ForeName>Erik</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands. Electronic address: e.s.stroes@amc.uva.nl.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colquhoun</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Wesley Medical Centre, Auchenflower, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sullivan</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Clinical Biochemistry, Royal Prince Alfred Hospital, Camperdown, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Civeira</LastName><ForeName>Fernando</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Hospital Universitario Miguel Servet, Zaragoza, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rosenson</LastName><ForeName>Robert S</ForeName><Initials>RS</Initials><AffiliationInfo><Affiliation>Cardiometabolic Disorders Department, Icahn School of Medicine at Mount Sinai, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Watts</LastName><ForeName>Gerald F</ForeName><Initials>GF</Initials><AffiliationInfo><Affiliation>Lipid Disorders Clinic, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bruckert</LastName><ForeName>Eric</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Hopital Pitie-Salpetriere, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cho</LastName><ForeName>Leslie</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Preventive Cardiology and Rehabilitation, Cleveland Clinic, Cleveland, Ohio.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dent</LastName><ForeName>Ricardo</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Amgen, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Knusel</LastName><ForeName>Beat</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Amgen, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xue</LastName><ForeName>Allen</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Amgen, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scott</LastName><ForeName>Rob</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Amgen, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wasserman</LastName><ForeName>Scott M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>Amgen, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rocco</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Cardiovascular Medicine Department, Cleveland Clinic, Cleveland, Ohio.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>GAUSS-2 Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01763905</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>03</Month><Day>30</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Am Coll Cardiol</MedlineTA><NlmUniqueID>8301365</NlmUniqueID><ISSNLinking>0735-1097</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C577155">AMG 145</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019161">Hydroxymethylglutaryl-CoA Reductase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>97C5T2UQ7J</RegistryNumber><NameOfSubstance UI="D002784">Cholesterol</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.21.-</RegistryNumber><NameOfSubstance UI="C472125">PCSK9 protein, human</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.21.-</RegistryNumber><NameOfSubstance UI="D000071449">Proprotein Convertase 9</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.21.-</RegistryNumber><NameOfSubstance UI="D043484">Proprotein Convertases</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 3.4.21.-</RegistryNumber><NameOfSubstance UI="D012697">Serine Endopeptidases</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017209" MajorTopicYN="N">Apoptosis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002784" MajorTopicYN="N">Cholesterol</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004361" MajorTopicYN="N">Drug Tolerance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019161" MajorTopicYN="N">Hydroxymethylglutaryl-CoA Reductase Inhibitors</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006937" MajorTopicYN="N">Hypercholesterolemia</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000071449" MajorTopicYN="N">Proprotein Convertase 9</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D043484" MajorTopicYN="N">Proprotein Convertases</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012697" MajorTopicYN="N">Serine Endopeptidases</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">LDL-cholesterol</Keyword><Keyword MajorTopicYN="N">evolocumab</Keyword><Keyword MajorTopicYN="N">ezetimibe</Keyword><Keyword MajorTopicYN="N">hypercholesterolemia</Keyword><Keyword MajorTopicYN="N">statin intolerance</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>02</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2014</Year><Month>03</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>03</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>4</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>4</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>8</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24694531</ArticleId><ArticleId IdType="pii">S0735-1097(14)01728-8</ArticleId><ArticleId IdType="doi">10.1016/j.jacc.2014.03.019</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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