Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial.
Identifieur interne : 001F68 ( PubMed/Checkpoint ); précédent : 001F67; suivant : 001F69Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial.
Auteurs : Steven E. Nissen [États-Unis] ; Erik Stroes [Pays-Bas] ; Ricardo E. Dent-Acosta [États-Unis] ; Robert S. Rosenson [États-Unis] ; Sam J. Lehman [Australie] ; Naveed Sattar [Royaume-Uni] ; David Preiss [Royaume-Uni] ; Eric Bruckert [France] ; Richard Ceška [République tchèque] ; Norman Lepor [États-Unis] ; Christie M. Ballantyne [États-Unis] ; Ioanna Gouni-Berthold [Allemagne] ; Mary Elliott [États-Unis] ; Danielle M. Brennan [États-Unis] ; Scott M. Wasserman [États-Unis] ; Ransi Somaratne [États-Unis] ; Rob Scott [États-Unis] ; Evan A. Stein [États-Unis]Source :
- JAMA [ 1538-3598 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Anticholestérolémiants (effets indésirables), Anticholestérolémiants (usage thérapeutique), Anticorps monoclonaux (effets indésirables), Anticorps monoclonaux (usage thérapeutique), Atorvastatine de calcium (effets indésirables), Cholestérol LDL (sang), Creatine kinase (sang), Facteurs temps, Femelle, Humains, Hypercholestérolémie (sang), Hypercholestérolémie (traitement médicamenteux), Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase (effets indésirables), Maladies musculaires (), Maladies musculaires (sang), Marqueurs biologiques (sang), Myalgie (), Myalgie (sang), Myosite (), Myosite (sang), Mâle, Méthode en double aveugle, Rhabdomyolyse (), Rhabdomyolyse (sang), Études croisées, Ézétimibe (effets indésirables), Ézétimibe (usage thérapeutique).
- MESH :
- effets indésirables : Anticholestérolémiants, Anticorps monoclonaux, Atorvastatine de calcium, Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase, Ézétimibe.
- sang : Cholestérol LDL, Creatine kinase, Hypercholestérolémie, Maladies musculaires, Marqueurs biologiques, Myalgie, Myosite, Rhabdomyolyse.
- traitement médicamenteux : Hypercholestérolémie.
- usage thérapeutique : Anticholestérolémiants, Anticorps monoclonaux, Ézétimibe.
- Adulte, Adulte d'âge moyen, Facteurs temps, Femelle, Humains, Maladies musculaires, Myalgie, Myosite, Mâle, Méthode en double aveugle, Rhabdomyolyse, Études croisées.
English descriptors
- KwdEn :
- Adult, Antibodies, Monoclonal (adverse effects), Antibodies, Monoclonal (therapeutic use), Anticholesteremic Agents (adverse effects), Anticholesteremic Agents (therapeutic use), Atorvastatin Calcium (adverse effects), Biomarkers (blood), Cholesterol, LDL (blood), Creatine Kinase (blood), Cross-Over Studies, Double-Blind Method, Ezetimibe (adverse effects), Ezetimibe (therapeutic use), Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors (adverse effects), Hypercholesterolemia (blood), Hypercholesterolemia (drug therapy), Male, Middle Aged, Muscular Diseases (blood), Muscular Diseases (chemically induced), Muscular Diseases (prevention & control), Myalgia (blood), Myalgia (chemically induced), Myalgia (prevention & control), Myositis (blood), Myositis (chemically induced), Myositis (prevention & control), Rhabdomyolysis (blood), Rhabdomyolysis (chemically induced), Rhabdomyolysis (prevention & control), Time Factors.
- MESH :
- chemical , adverse effects : Antibodies, Monoclonal, Anticholesteremic Agents, Atorvastatin Calcium, Ezetimibe, Hydroxymethylglutaryl-CoA Reductase Inhibitors.
- chemical , blood : Biomarkers, Cholesterol, LDL, Creatine Kinase.
- chemical , therapeutic use : Antibodies, Monoclonal, Anticholesteremic Agents, Ezetimibe.
- blood : Hypercholesterolemia, Muscular Diseases, Myalgia, Myositis, Rhabdomyolysis.
- chemically induced : Muscular Diseases, Myalgia, Myositis, Rhabdomyolysis.
- drug therapy : Hypercholesterolemia.
- prevention & control : Muscular Diseases, Myalgia, Myositis, Rhabdomyolysis.
- Adult, Cross-Over Studies, Double-Blind Method, Female, Humans, Male, Middle Aged, Time Factors.
Abstract
Muscle-related statin intolerance is reported by 5% to 20% of patients.
DOI: 10.1001/jama.2016.3608
PubMed: 27039291
Affiliations:
- Allemagne, Australie, France, Pays-Bas, Royaume-Uni, République tchèque, États-Unis
- Angleterre, Bohême centrale, Californie, Hollande-Septentrionale, Ohio, Oxfordshire, Texas, Écosse, État de New York, Île-de-France
- Amsterdam, Glasgow, Los Angeles, Oxford, Paris, Prague
- Université d'Oxford, Université de Glasgow
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:27039291Le document en format XML
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Nissen</name><affiliation wicri:level="2"><nlm:affiliation>Cleveland Clinic, Cleveland, Ohio.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Cleveland Clinic, Cleveland</wicri:cityArea></affiliation></author><author><name sortKey="Stroes, Erik" sort="Stroes, Erik" uniqKey="Stroes E" first="Erik" last="Stroes">Erik Stroes</name><affiliation wicri:level="3"><nlm:affiliation>University of Amsterdam Faculty of Medicine, Amsterdam, the Netherlands.</nlm:affiliation><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>University of Amsterdam Faculty of Medicine, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Dent Acosta, Ricardo E" sort="Dent Acosta, Ricardo E" uniqKey="Dent Acosta R" first="Ricardo E" last="Dent-Acosta">Ricardo E. Dent-Acosta</name><affiliation wicri:level="2"><nlm:affiliation>Amgen Inc, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen Inc, Thousand Oaks</wicri:cityArea></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>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>School of Medicine at Mount Sinai, New York</wicri:cityArea></affiliation></author><author><name sortKey="Lehman, Sam J" sort="Lehman, Sam J" uniqKey="Lehman S" first="Sam J" last="Lehman">Sam J. Lehman</name><affiliation wicri:level="1"><nlm:affiliation>Flinders University, Bedford Park, SA, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Flinders University, Bedford Park, SA</wicri:regionArea><wicri:noRegion>SA</wicri:noRegion></affiliation></author><author><name sortKey="Sattar, Naveed" sort="Sattar, Naveed" uniqKey="Sattar N" first="Naveed" last="Sattar">Naveed Sattar</name><affiliation wicri:level="4"><nlm:affiliation>University of Glasgow, Glasgow, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University of Glasgow, Glasgow</wicri:regionArea><orgName type="university">Université de Glasgow</orgName><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Preiss, David" sort="Preiss, David" uniqKey="Preiss D" first="David" last="Preiss">David Preiss</name><affiliation wicri:level="4"><nlm:affiliation>Clinical Trial Service Unit, University of Oxford, Oxford, United Kingdom8Epidemiological Services Unit, University of Oxford, Oxford, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Clinical Trial Service Unit, University of Oxford, Oxford, United Kingdom8Epidemiological Services Unit, University of Oxford, Oxford</wicri:regionArea><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Bruckert, Eric" sort="Bruckert, Eric" uniqKey="Bruckert E" first="Eric" last="Bruckert">Eric Bruckert</name><affiliation wicri:level="3"><nlm:affiliation>University Hospital of Paris 6, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>University Hospital of Paris 6, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Ceska, Richard" sort="Ceska, Richard" uniqKey="Ceska R" first="Richard" last="Ceška">Richard Ceška</name><affiliation wicri:level="3"><nlm:affiliation>Charles University in Prague, Prague, Czech Republic11General University Hospital in Prague, Prague, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Charles University in Prague, Prague, Czech Republic11General University Hospital in Prague, Prague</wicri:regionArea><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Lepor, Norman" sort="Lepor, Norman" uniqKey="Lepor N" first="Norman" last="Lepor">Norman Lepor</name><affiliation wicri:level="3"><nlm:affiliation>David Geffen School of Medicine at the University of California, Los Angeles.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName><wicri:orgArea>David Geffen School of Medicine at the University of California</wicri:orgArea></affiliation></author><author><name sortKey="Ballantyne, Christie M" sort="Ballantyne, Christie M" uniqKey="Ballantyne C" first="Christie M" last="Ballantyne">Christie M. Ballantyne</name><affiliation wicri:level="2"><nlm:affiliation>Baylor College of Medicine, Houston, Texas.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author><author><name sortKey="Gouni Berthold, Ioanna" sort="Gouni Berthold, Ioanna" uniqKey="Gouni Berthold I" first="Ioanna" last="Gouni-Berthold">Ioanna Gouni-Berthold</name><affiliation wicri:level="1"><nlm:affiliation>Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne</wicri:regionArea><wicri:noRegion>Cologne</wicri:noRegion><wicri:noRegion>Cologne</wicri:noRegion><wicri:noRegion>Cologne</wicri:noRegion></affiliation></author><author><name sortKey="Elliott, Mary" sort="Elliott, Mary" uniqKey="Elliott M" first="Mary" last="Elliott">Mary Elliott</name><affiliation wicri:level="2"><nlm:affiliation>Amgen Inc, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen Inc, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Brennan, Danielle M" sort="Brennan, Danielle M" uniqKey="Brennan D" first="Danielle M" last="Brennan">Danielle M. Brennan</name><affiliation wicri:level="2"><nlm:affiliation>Cleveland Clinic, Cleveland, Ohio.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Cleveland Clinic, Cleveland</wicri:cityArea></affiliation></author><author><name sortKey="Wasserman, Scott M" sort="Wasserman, Scott M" uniqKey="Wasserman S" first="Scott M" last="Wasserman">Scott M. 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Stein</name><affiliation wicri:level="2"><nlm:affiliation>Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Metabolic and Atherosclerosis Research Center, Cincinnati</wicri:cityArea></affiliation></author></analytic><series><title level="j">JAMA</title><idno type="eISSN">1538-3598</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Antibodies, Monoclonal (adverse effects)</term><term>Antibodies, Monoclonal (therapeutic use)</term><term>Anticholesteremic Agents (adverse effects)</term><term>Anticholesteremic Agents (therapeutic use)</term><term>Atorvastatin Calcium (adverse effects)</term><term>Biomarkers (blood)</term><term>Cholesterol, LDL (blood)</term><term>Creatine Kinase (blood)</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Ezetimibe (adverse effects)</term><term>Ezetimibe (therapeutic use)</term><term>Female</term><term>Humans</term><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors (adverse effects)</term><term>Hypercholesterolemia (blood)</term><term>Hypercholesterolemia (drug therapy)</term><term>Male</term><term>Middle Aged</term><term>Muscular Diseases (blood)</term><term>Muscular Diseases (chemically induced)</term><term>Muscular Diseases (prevention & control)</term><term>Myalgia (blood)</term><term>Myalgia (chemically induced)</term><term>Myalgia (prevention & control)</term><term>Myositis (blood)</term><term>Myositis (chemically induced)</term><term>Myositis (prevention & control)</term><term>Rhabdomyolysis (blood)</term><term>Rhabdomyolysis (chemically induced)</term><term>Rhabdomyolysis (prevention & control)</term><term>Time Factors</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticholestérolémiants (effets indésirables)</term><term>Anticholestérolémiants (usage thérapeutique)</term><term>Anticorps monoclonaux (effets indésirables)</term><term>Anticorps monoclonaux (usage thérapeutique)</term><term>Atorvastatine de calcium (effets indésirables)</term><term>Cholestérol LDL (sang)</term><term>Creatine kinase (sang)</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Hypercholestérolémie (sang)</term><term>Hypercholestérolémie (traitement médicamenteux)</term><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase (effets indésirables)</term><term>Maladies musculaires ()</term><term>Maladies musculaires (sang)</term><term>Marqueurs biologiques (sang)</term><term>Myalgie ()</term><term>Myalgie (sang)</term><term>Myosite ()</term><term>Myosite (sang)</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Rhabdomyolyse ()</term><term>Rhabdomyolyse (sang)</term><term>Études croisées</term><term>Ézétimibe (effets indésirables)</term><term>Ézétimibe (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Anticholesteremic Agents</term><term>Atorvastatin Calcium</term><term>Ezetimibe</term><term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Biomarkers</term><term>Cholesterol, LDL</term><term>Creatine Kinase</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Anticholesteremic Agents</term><term>Ezetimibe</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Hypercholesterolemia</term><term>Muscular Diseases</term><term>Myalgia</term><term>Myositis</term><term>Rhabdomyolysis</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Muscular Diseases</term><term>Myalgia</term><term>Myositis</term><term>Rhabdomyolysis</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hypercholesterolemia</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticholestérolémiants</term><term>Anticorps monoclonaux</term><term>Atorvastatine de calcium</term><term>Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase</term><term>Ézétimibe</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Muscular Diseases</term><term>Myalgia</term><term>Myositis</term><term>Rhabdomyolysis</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Cholestérol LDL</term><term>Creatine kinase</term><term>Hypercholestérolémie</term><term>Maladies musculaires</term><term>Marqueurs biologiques</term><term>Myalgie</term><term>Myosite</term><term>Rhabdomyolyse</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hypercholestérolémie</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticholestérolémiants</term><term>Anticorps monoclonaux</term><term>Ézétimibe</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Time Factors</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Maladies musculaires</term><term>Myalgie</term><term>Myosite</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Rhabdomyolyse</term><term>Études croisées</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Muscle-related statin intolerance is reported by 5% to 20% of patients.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27039291</PMID><DateCreated><Year>2016</Year><Month>04</Month><Day>20</Day></DateCreated><DateCompleted><Year>2016</Year><Month>05</Month><Day>01</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>16</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1538-3598</ISSN><JournalIssue CitedMedium="Internet"><Volume>315</Volume><Issue>15</Issue><PubDate><Year>2016</Year><Month>Apr</Month><Day>19</Day></PubDate></JournalIssue><Title>JAMA</Title><ISOAbbreviation>JAMA</ISOAbbreviation></Journal><ArticleTitle>Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial.</ArticleTitle><Pagination><MedlinePgn>1580-90</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1001/jama.2016.3608</ELocationID><Abstract><AbstractText Label="IMPORTANCE" NlmCategory="OBJECTIVE">Muscle-related statin intolerance is reported by 5% to 20% of patients.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To identify patients with muscle symptoms confirmed by statin rechallenge and compare lipid-lowering efficacy for 2 nonstatin therapies, ezetimibe and evolocumab.</AbstractText><AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">Two-stage randomized clinical trial including 511 adult patients with uncontrolled low-density lipoprotein cholesterol (LDL-C) levels and history of intolerance to 2 or more statins enrolled in 2013 and 2014 globally. Phase A used a 24-week crossover procedure with atorvastatin or placebo to identify patients having symptoms only with atorvastatin but not placebo. In phase B, after a 2-week washout, patients were randomized to ezetimibe or evolocumab for 24 weeks.</AbstractText><AbstractText Label="INTERVENTIONS" NlmCategory="METHODS">Phase A: atorvastatin (20 mg) vs placebo. Phase B: randomization 2:1 to subcutaneous evolocumab (420 mg monthly) or oral ezetimibe (10 mg daily).</AbstractText><AbstractText Label="MAIN OUTCOME AND MEASURES" NlmCategory="METHODS">Coprimary end points were the mean percent change in LDL-C level from baseline to the mean of weeks 22 and 24 levels and from baseline to week 24 levels.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Of the 491 patients who entered phase A (mean age, 60.7 [SD, 10.2] years; 246 women [50.1%]; 170 with coronary heart disease [34.6%]; entry mean LDL-C level, 212.3 [SD, 67.9] mg/dL), muscle symptoms occurred in 209 of 491 (42.6%) while taking atorvastatin but not while taking placebo. Of these, 199 entered phase B, along with 19 who proceeded directly to phase B for elevated creatine kinase (N = 218, with 73 randomized to ezetimibe and 145 to evolocumab; entry mean LDL-C level, 219.9 [SD, 72] mg/dL). For the mean of weeks 22 and 24, LDL-C level with ezetimibe was 183.0 mg/dL; mean percent LDL-C change, -16.7% (95% CI, -20.5% to -12.9%), absolute change, -31.0 mg/dL and with evolocumab was 103.6 mg/dL; mean percent change, -54.5% (95% CI, -57.2% to -51.8%); absolute change, -106.8 mg/dL (P < .001). LDL-C level at week 24 with ezetimibe was 181.5 mg/dL; mean percent change, -16.7% (95% CI, -20.8% to -12.5%); absolute change, -31.2 mg/dL and with evolocumab was 104.1 mg/dL; mean percent change, -52.8% (95% CI, -55.8% to -49.8%); absolute change, -102.9 mg/dL (P < .001). For the mean of weeks 22 and 24, between-group difference in LDL-C was -37.8%; absolute difference, -75.8 mg/dL. For week 24, between-group difference in LDL-C was -36.1%; absolute difference, -71.7 mg/dL. Muscle symptoms were reported in 28.8% of ezetimibe-treated patients and 20.7% of evolocumab-treated patients (log-rank P = .17). Active study drug was stopped for muscle symptoms in 5 of 73 ezetimibe-treated patients (6.8%) and 1 of 145 evolocumab-treated patients (0.7%).</AbstractText><AbstractText Label="CONCLUSIONS AND RELEVANCE" NlmCategory="CONCLUSIONS">Among patients with statin intolerance related to muscle-related adverse effects, the use of evolocumab compared with ezetimibe resulted in a significantly greater reduction in LDL-C levels after 24 weeks. Further studies are needed to assess long-term efficacy and safety.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">clinicaltrials.gov Identifier: NCT01984424.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Nissen</LastName><ForeName>Steven E</ForeName><Initials>SE</Initials><AffiliationInfo><Affiliation>Cleveland Clinic, Cleveland, Ohio.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stroes</LastName><ForeName>Erik</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>University of Amsterdam Faculty of Medicine, Amsterdam, the Netherlands.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dent-Acosta</LastName><ForeName>Ricardo E</ForeName><Initials>RE</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rosenson</LastName><ForeName>Robert S</ForeName><Initials>RS</Initials><AffiliationInfo><Affiliation>School of Medicine at Mount Sinai, New York, New York.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lehman</LastName><ForeName>Sam J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>Flinders University, Bedford Park, SA, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sattar</LastName><ForeName>Naveed</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>University of Glasgow, Glasgow, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Preiss</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Clinical Trial Service Unit, University of Oxford, Oxford, United Kingdom8Epidemiological Services Unit, University of Oxford, Oxford, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bruckert</LastName><ForeName>Eric</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>University Hospital of Paris 6, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ceška</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Charles University in Prague, Prague, Czech Republic11General University Hospital in Prague, Prague, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lepor</LastName><ForeName>Norman</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>David Geffen School of Medicine at the University of California, Los Angeles.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ballantyne</LastName><ForeName>Christie M</ForeName><Initials>CM</Initials><AffiliationInfo><Affiliation>Baylor College of Medicine, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gouni-Berthold</LastName><ForeName>Ioanna</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elliott</LastName><ForeName>Mary</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brennan</LastName><ForeName>Danielle M</ForeName><Initials>DM</Initials><AffiliationInfo><Affiliation>Cleveland Clinic, Cleveland, Ohio.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wasserman</LastName><ForeName>Scott M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Somaratne</LastName><ForeName>Ransi</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scott</LastName><ForeName>Rob</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stein</LastName><ForeName>Evan A</ForeName><Initials>EA</Initials><AffiliationInfo><Affiliation>Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>GAUSS-3 Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01984424</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>JAMA</MedlineTA><NlmUniqueID>7501160</NlmUniqueID><ISSNLinking>0098-7484</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="D000924">Anticholesteremic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015415">Biomarkers</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008078">Cholesterol, LDL</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019161">Hydroxymethylglutaryl-CoA Reductase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>48A5M73Z4Q</RegistryNumber><NameOfSubstance UI="D000069059">Atorvastatin Calcium</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.3.2</RegistryNumber><NameOfSubstance UI="D003402">Creatine Kinase</NameOfSubstance></Chemical><Chemical><RegistryNumber>EOR26LQQ24</RegistryNumber><NameOfSubstance UI="D000069438">Ezetimibe</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>JAMA. 2016 Apr 19;315(15):1571-2</RefSource><PMID Version="1">27039138</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>BMJ. 2016;353:i1926</RefSource><PMID Version="1">27048348</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000924" MajorTopicYN="N">Anticholesteremic Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000069059" MajorTopicYN="N">Atorvastatin Calcium</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015415" MajorTopicYN="N">Biomarkers</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008078" MajorTopicYN="N">Cholesterol, LDL</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003402" MajorTopicYN="N">Creatine Kinase</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018592" MajorTopicYN="N">Cross-Over Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000069438" MajorTopicYN="N">Ezetimibe</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019161" MajorTopicYN="N">Hydroxymethylglutaryl-CoA Reductase Inhibitors</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</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></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009135" MajorTopicYN="N">Muscular Diseases</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D063806" MajorTopicYN="N">Myalgia</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009220" MajorTopicYN="N">Myositis</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012206" MajorTopicYN="N">Rhabdomyolysis</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Sullivan</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lehman</LastName><ForeName>Sam</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kostner</LastName><ForeName>Karam</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Wauchope</LastName><ForeName>Andrew Don</ForeName><Initials>AD</Initials></Investigator><Investigator ValidYN="Y"><LastName>Hartleib</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Baass</LastName><ForeName>Alexis</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bergeron</LastName><ForeName>Jean</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Joy</LastName><ForeName>Tisha</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Češka</LastName><ForeName>Richard</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Adamkova</LastName><ForeName>Vera</ForeName><Initials>V</Initials></Investigator><Investigator ValidYN="Y"><LastName>Blaha</LastName><ForeName>Vladimir</ForeName><Initials>V</Initials></Investigator><Investigator ValidYN="Y"><LastName>Jeppesen</LastName><ForeName>Jorgen</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Jensen</LastName><ForeName>Henrik Kjaerulf</ForeName><Initials>HK</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bruckert</LastName><ForeName>Eric</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Krempf</LastName><ForeName>Michel</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bully</LastName><ForeName>Chantal</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bosiljanoff</LastName><ForeName>Peter</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Gouni-Berthold</LastName><ForeName>Ioanna</ForeName><Initials>I</Initials></Investigator><Investigator ValidYN="Y"><LastName>Steinhagen-Thiessen</LastName><ForeName>Elisabeth</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pintus</LastName><ForeName>Paolo</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Borghi</LastName><ForeName>Claudio</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Sampietro</LastName><ForeName>Tiziana</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Vigna</LastName><ForeName>Giovanni Battista</ForeName><Initials>GB</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mannarino</LastName><ForeName>Elmo</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pozzi</LastName><ForeName>Claudio</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Stroes</LastName><ForeName>Erik</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Liem</LastName><ForeName>Anho</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Van Leendert</LastName><ForeName>Rudolf</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Scott</LastName><ForeName>Russell</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kjaernli</LastName><ForeName>Thorbjorn</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Langslet</LastName><ForeName>Gisle</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Jacovides</LastName><ForeName>Andrew</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Klug</LastName><ForeName>Eric</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Blom</LastName><ForeName>Dirk</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Preiss</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Neely</LastName><ForeName>Dermot</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Dawson</LastName><ForeName>Charlotte</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Miller</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Rosenson</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>McCullum</LastName><ForeName>Kevin</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ballantyne</LastName><ForeName>Christie</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Rocco</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Shah</LastName><ForeName>Prediman</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Lepor</LastName><ForeName>Norman</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Rosenblit</LastName><ForeName>Paul</ForeName><Initials>P</Initials></Investigator><Investigator 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ValidYN="Y"><LastName>Kopecky</LastName><ForeName>Stephen</ForeName><Initials>S</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>4</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>4</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>5</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27039291</ArticleId><ArticleId IdType="pii">2511043</ArticleId><ArticleId IdType="doi">10.1001/jama.2016.3608</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>République 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Nissen</name></region><name sortKey="Ballantyne, Christie M" sort="Ballantyne, Christie M" uniqKey="Ballantyne C" first="Christie M" last="Ballantyne">Christie M. Ballantyne</name><name sortKey="Brennan, Danielle M" sort="Brennan, Danielle M" uniqKey="Brennan D" first="Danielle M" last="Brennan">Danielle M. Brennan</name><name sortKey="Dent Acosta, Ricardo E" sort="Dent Acosta, Ricardo E" uniqKey="Dent Acosta R" first="Ricardo E" last="Dent-Acosta">Ricardo E. Dent-Acosta</name><name sortKey="Elliott, Mary" sort="Elliott, Mary" uniqKey="Elliott M" first="Mary" last="Elliott">Mary Elliott</name><name sortKey="Lepor, Norman" sort="Lepor, Norman" uniqKey="Lepor N" first="Norman" last="Lepor">Norman Lepor</name><name sortKey="Rosenson, Robert S" sort="Rosenson, Robert S" uniqKey="Rosenson R" first="Robert S" last="Rosenson">Robert S. 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Lehman</name></noRegion></country><country name="Royaume-Uni"><region name="Écosse"><name sortKey="Sattar, Naveed" sort="Sattar, Naveed" uniqKey="Sattar N" first="Naveed" last="Sattar">Naveed Sattar</name></region><name sortKey="Preiss, David" sort="Preiss, David" uniqKey="Preiss D" first="David" last="Preiss">David Preiss</name></country><country name="France"><region name="Île-de-France"><name sortKey="Bruckert, Eric" sort="Bruckert, Eric" uniqKey="Bruckert E" first="Eric" last="Bruckert">Eric Bruckert</name></region></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Ceska, Richard" sort="Ceska, Richard" uniqKey="Ceska R" first="Richard" last="Ceška">Richard Ceška</name></region></country><country name="Allemagne"><noRegion><name sortKey="Gouni Berthold, Ioanna" sort="Gouni Berthold, Ioanna" uniqKey="Gouni Berthold I" first="Ioanna" last="Gouni-Berthold">Ioanna Gouni-Berthold</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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