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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial</title><author><name sortKey="Bays, Harold" sort="Bays, Harold" uniqKey="Bays H" first="Harold" last="Bays">Harold Bays</name></author><author><name sortKey="Gaudet, Daniel" sort="Gaudet, Daniel" uniqKey="Gaudet D" first="Daniel" last="Gaudet">Daniel Gaudet</name></author><author><name sortKey="Weiss, Robert" sort="Weiss, Robert" uniqKey="Weiss R" first="Robert" last="Weiss">Robert Weiss</name></author><author><name sortKey="Ruiz, Juan Lima" sort="Ruiz, Juan Lima" uniqKey="Ruiz J" first="Juan Lima" last="Ruiz">Juan Lima Ruiz</name></author><author><name sortKey="Watts, Gerald F" sort="Watts, Gerald F" uniqKey="Watts G" first="Gerald F." last="Watts">Gerald F. Watts</name></author><author><name sortKey="Gouni Berthold, Ioanna" sort="Gouni Berthold, Ioanna" uniqKey="Gouni Berthold I" first="Ioanna" last="Gouni-Berthold">Ioanna Gouni-Berthold</name></author><author><name sortKey="Robinson, Jennifer" sort="Robinson, Jennifer" uniqKey="Robinson J" first="Jennifer" last="Robinson">Jennifer Robinson</name></author><author><name sortKey="Zhao, Jian" sort="Zhao, Jian" uniqKey="Zhao J" first="Jian" last="Zhao">Jian Zhao</name></author><author><name sortKey="Hanotin, Corinne" sort="Hanotin, Corinne" uniqKey="Hanotin C" first="Corinne" last="Hanotin">Corinne Hanotin</name></author><author><name sortKey="Donahue, Stephen" sort="Donahue, Stephen" uniqKey="Donahue S" first="Stephen" last="Donahue">Stephen Donahue</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26030325</idno><idno type="pmc">4524987</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4524987</idno><idno type="RBID">PMC:4524987</idno><idno type="doi">10.1210/jc.2015-1520</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000197</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000197</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial</title><author><name sortKey="Bays, Harold" sort="Bays, Harold" uniqKey="Bays H" first="Harold" last="Bays">Harold Bays</name></author><author><name sortKey="Gaudet, Daniel" sort="Gaudet, Daniel" uniqKey="Gaudet D" first="Daniel" last="Gaudet">Daniel Gaudet</name></author><author><name sortKey="Weiss, Robert" sort="Weiss, Robert" uniqKey="Weiss R" first="Robert" last="Weiss">Robert Weiss</name></author><author><name sortKey="Ruiz, Juan Lima" sort="Ruiz, Juan Lima" uniqKey="Ruiz J" first="Juan Lima" last="Ruiz">Juan Lima Ruiz</name></author><author><name sortKey="Watts, Gerald F" sort="Watts, Gerald F" uniqKey="Watts G" first="Gerald F." last="Watts">Gerald F. Watts</name></author><author><name sortKey="Gouni Berthold, Ioanna" sort="Gouni Berthold, Ioanna" uniqKey="Gouni Berthold I" first="Ioanna" last="Gouni-Berthold">Ioanna Gouni-Berthold</name></author><author><name sortKey="Robinson, Jennifer" sort="Robinson, Jennifer" uniqKey="Robinson J" first="Jennifer" last="Robinson">Jennifer Robinson</name></author><author><name sortKey="Zhao, Jian" sort="Zhao, Jian" uniqKey="Zhao J" first="Jian" last="Zhao">Jian Zhao</name></author><author><name sortKey="Hanotin, Corinne" sort="Hanotin, Corinne" uniqKey="Hanotin C" first="Corinne" last="Hanotin">Corinne Hanotin</name></author><author><name sortKey="Donahue, Stephen" sort="Donahue, Stephen" uniqKey="Donahue S" first="Stephen" last="Donahue">Stephen Donahue</name></author></analytic><series><title level="j">The Journal of Clinical Endocrinology and Metabolism</title><idno type="ISSN">0021-972X</idno><idno type="eISSN">1945-7197</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><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><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Clin Endocrinol Metab</journal-id><journal-id journal-id-type="iso-abbrev">J. Clin. Endocrinol. Metab</journal-id><journal-id journal-id-type="hwp">jcem</journal-id><journal-id journal-id-type="publisher-id">jceme</journal-id><journal-id journal-id-type="pmc">jcem</journal-id><journal-title-group><journal-title>The Journal of Clinical Endocrinology and Metabolism</journal-title></journal-title-group><issn pub-type="ppub">0021-972X</issn><issn pub-type="epub">1945-7197</issn><publisher><publisher-name>Endocrine Society</publisher-name><publisher-loc>Chevy Chase, MD</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26030325</article-id><article-id pub-id-type="pmc">4524987</article-id><article-id pub-id-type="publisher-id">15-1520</article-id><article-id pub-id-type="doi">10.1210/jc.2015-1520</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>3</subject><subject>14</subject></subj-group><subj-group subj-group-type="heading"><subject>Original Articles</subject></subj-group></article-categories><title-group><article-title>Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Bays</surname><given-names>Harold</given-names></name></contrib><contrib contrib-type="author"><name><surname>Gaudet</surname><given-names>Daniel</given-names></name></contrib><contrib contrib-type="author"><name><surname>Weiss</surname><given-names>Robert</given-names></name></contrib><contrib contrib-type="author"><name><surname>Ruiz</surname><given-names>Juan Lima</given-names></name></contrib><contrib contrib-type="author"><name><surname>Watts</surname><given-names>Gerald F.</given-names></name></contrib><contrib contrib-type="author"><name><surname>Gouni-Berthold</surname><given-names>Ioanna</given-names></name></contrib><contrib contrib-type="author"><name><surname>Robinson</surname><given-names>Jennifer</given-names></name></contrib><contrib contrib-type="author"><name><surname>Zhao</surname><given-names>Jian</given-names></name></contrib><contrib contrib-type="author"><name><surname>Hanotin</surname><given-names>Corinne</given-names></name></contrib><contrib contrib-type="author"><name><surname>Donahue</surname><given-names>Stephen</given-names></name></contrib><aff>Louisville Metabolic and Atherosclerosis Research Center (H.B.), Louisville, Kentucky 40213; ECOGENE-21 Clinical Trial Center and Department of Medicine (D.G.), Université de Montréal, Chicoutimi, Québec, Canada G7H 5H6; Maine Research Associates (R.W.), Auburn, Maine 04210; Lipid and Vascular Research Unit (J.L.R.), University Hospital Vall d'Hebron, 8035 Barcelona, Spain; Lipid Disorders Clinic (G.F.W.), Centre for Cardiovascular Medicine, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia 6009, Australia; Center for Endocrinology, Diabetes and Preventive Medicine (I.G.-B.), University of Cologne, 50923 Cologne, Germany; University of Iowa (J.R.), Iowa City, Iowa 52242; Regeneron Pharmaceuticals, Inc (J.Z., S.D.), Tarrytown, New York 10591; and Sanofi (C.H.), 75014 Paris, France</aff></contrib-group><author-notes><corresp>Address all correspondence and requests for reprints to: Harold Bays, MD, Louisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Avenue, Louisville, KY 40213. E-mail: <email>hbaysmd@aol.com</email>.</corresp></author-notes><pub-date pub-type="ppub"><month>8</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>1</day><month>6</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>6</month><year>2015</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>100</volume><issue>8</issue><fpage>3140</fpage><lpage>3148</lpage><history><date date-type="received"><day>26</day><month>2</month><year>2015</year></date><date date-type="accepted"><day>28</day><month>5</month><year>2015</year></date></history><permissions><copyright-statement>Copyright © 2015 by the Endocrine Society</copyright-statement><copyright-year>2015</copyright-year></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="zeg00815003140.pdf"></self-uri><abstract><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></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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