Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
Identifieur interne : 000992 ( Istex/Corpus ); précédent : 000991; suivant : 000993Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial
Auteurs : Evan A. Stein ; Eli M. Roth ; James M. Rhyne ; Tracy Burgess ; David Kallend ; Jennifer G. RobinsonSource :
- European Heart Journal [ 0195-668X ] ; 2010-02.
Abstract
Aims Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. Methods and results Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4, Week 24; 33.8, Week 48), decreased CETP activity (53.5, Week 24; 56.5, Week 48), and increased apolipoprotein A-I (11.4, Week 24; 16.4, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. Conclusion Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment.
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DOI: 10.1093/eurheartj/ehp601
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Rhyne</name><affiliation><mods:affiliation>The Lipid Center, Statesville, NC, USA</mods:affiliation></affiliation></author><author><name sortKey="Burgess, Tracy" sort="Burgess, Tracy" uniqKey="Burgess T" first="Tracy" last="Burgess">Tracy Burgess</name><affiliation><mods:affiliation>Hoffmann-La Roche Inc., Nutley, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Kallend, David" sort="Kallend, David" uniqKey="Kallend D" first="David" last="Kallend">David Kallend</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Robinson, Jennifer G" sort="Robinson, Jennifer G" uniqKey="Robinson J" first="Jennifer G." last="Robinson">Jennifer G. Robinson</name><affiliation><mods:affiliation>Lipid Research Clinic, The University of Iowa, Iowa City, IA, USA</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:C3BDE6B10833703DFF65A1644E90ABE7C6001361</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1093/eurheartj/ehp601</idno><idno type="url">https://api.istex.fr/document/C3BDE6B10833703DFF65A1644E90ABE7C6001361/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000992</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial</title><author><name sortKey="Stein, Evan A" sort="Stein, Evan A" uniqKey="Stein E" first="Evan A." last="Stein">Evan A. Stein</name><affiliation><mods:affiliation>Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: esteinmrl@aol.com</mods:affiliation></affiliation></author><author><name sortKey="Roth, Eli M" sort="Roth, Eli M" uniqKey="Roth E" first="Eli M." last="Roth">Eli M. Roth</name><affiliation><mods:affiliation>Sterling Research Group, Cincinnati, OH, USA</mods:affiliation></affiliation></author><author><name sortKey="Rhyne, James M" sort="Rhyne, James M" uniqKey="Rhyne J" first="James M." last="Rhyne">James M. Rhyne</name><affiliation><mods:affiliation>The Lipid Center, Statesville, NC, USA</mods:affiliation></affiliation></author><author><name sortKey="Burgess, Tracy" sort="Burgess, Tracy" uniqKey="Burgess T" first="Tracy" last="Burgess">Tracy Burgess</name><affiliation><mods:affiliation>Hoffmann-La Roche Inc., Nutley, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Kallend, David" sort="Kallend, David" uniqKey="Kallend D" first="David" last="Kallend">David Kallend</name><affiliation><mods:affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</mods:affiliation></affiliation></author><author><name sortKey="Robinson, Jennifer G" sort="Robinson, Jennifer G" uniqKey="Robinson J" first="Jennifer G." last="Robinson">Jennifer G. Robinson</name><affiliation><mods:affiliation>Lipid Research Clinic, The University of Iowa, Iowa City, IA, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">European Heart Journal</title><idno type="ISSN">0195-668X</idno><idno type="eISSN">1522-9645</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2010-02">2010-02</date><biblScope unit="volume">31</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="480">480</biblScope><biblScope unit="page" to="488">488</biblScope></imprint><idno type="ISSN">0195-668X</idno></series><idno type="istex">C3BDE6B10833703DFF65A1644E90ABE7C6001361</idno><idno type="DOI">10.1093/eurheartj/ehp601</idno><idno type="ArticleID">ehp601</idno><idno type="Related-article-href">10.1093/eurheartj/ehp394</idno><idno type="related-article-ID">RA1</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0195-668X</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Aims Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. Methods and results Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4, Week 24; 33.8, Week 48), decreased CETP activity (53.5, Week 24; 56.5, Week 48), and increased apolipoprotein A-I (11.4, Week 24; 16.4, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. Conclusion Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment.</div></front></TEI><istex><corpusName>oup</corpusName><author><json:item><name>Evan A. Stein</name><affiliations><json:string>Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212, USA</json:string><json:string>E-mail: esteinmrl@aol.com</json:string></affiliations></json:item><json:item><name>Eli M. Roth</name><affiliations><json:string>Sterling Research Group, Cincinnati, OH, USA</json:string></affiliations></json:item><json:item><name>James M. Rhyne</name><affiliations><json:string>The Lipid Center, Statesville, NC, USA</json:string></affiliations></json:item><json:item><name>Tracy Burgess</name><affiliations><json:string>Hoffmann-La Roche Inc., Nutley, NJ, USA</json:string></affiliations></json:item><json:item><name>David Kallend</name><affiliations><json:string>F. Hoffmann-La Roche Ltd, Basel, Switzerland</json:string></affiliations></json:item><json:item><name>Jennifer G. Robinson</name><affiliations><json:string>Lipid Research Clinic, The University of Iowa, Iowa City, IA, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>CETP</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Dalcetrapib</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>HDL-C</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Lymph node</value></json:item></subject><articleId><json:string>ehp601</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Aims Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. Methods and results Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4, Week 24; 33.8, Week 48), decreased CETP activity (53.5, Week 24; 56.5, Week 48), and increased apolipoprotein A-I (11.4, Week 24; 16.4, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. Conclusion Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. 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All rights reserved. The Author 2010. For permissions please email: journals.permissionsoxfordjournals.org.</p></availability><date>2010-01-22</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial</title><author xml:id="author-1"><persName><forename type="first">Evan A.</forename><surname>Stein</surname></persName><email>esteinmrl@aol.com</email><affiliation>Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212, USA</affiliation></author><author xml:id="author-2"><persName><forename type="first">Eli M.</forename><surname>Roth</surname></persName><affiliation>Sterling Research Group, Cincinnati, OH, USA</affiliation></author><author xml:id="author-3"><persName><forename type="first">James M.</forename><surname>Rhyne</surname></persName><affiliation>The Lipid Center, Statesville, NC, USA</affiliation></author><author xml:id="author-4"><persName><forename type="first">Tracy</forename><surname>Burgess</surname></persName><affiliation>Hoffmann-La Roche Inc., Nutley, NJ, USA</affiliation></author><author xml:id="author-5"><persName><forename type="first">David</forename><surname>Kallend</surname></persName><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</affiliation></author><author xml:id="author-6"><persName><forename type="first">Jennifer G.</forename><surname>Robinson</surname></persName><affiliation>Lipid Research Clinic, The University of Iowa, Iowa City, IA, USA</affiliation></author></analytic><monogr><title level="j">European Heart Journal</title><idno type="pISSN">0195-668X</idno><idno type="eISSN">1522-9645</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2010-02"></date><biblScope unit="volume">31</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="480">480</biblScope><biblScope unit="page" to="488">488</biblScope></imprint></monogr><idno type="istex">C3BDE6B10833703DFF65A1644E90ABE7C6001361</idno><idno type="DOI">10.1093/eurheartj/ehp601</idno><idno type="ArticleID">ehp601</idno><idno type="Related-article-href">10.1093/eurheartj/ehp394</idno><idno type="related-article-ID">RA1</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2010-01-22</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Aims Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. Methods and results Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4, Week 24; 33.8, Week 48), decreased CETP activity (53.5, Week 24; 56.5, Week 48), and increased apolipoprotein A-I (11.4, Week 24; 16.4, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. Conclusion Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>CETP</term></item><item><term>Dalcetrapib</term></item><item><term>HDL-C</term></item><item><term>Lymph node</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2010-01-22">Created</change><change when="2010-02">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/C3BDE6B10833703DFF65A1644E90ABE7C6001361/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">ehj</journal-id><journal-id journal-id-type="publisher-id">eurheartj</journal-id><journal-title>European Heart Journal</journal-title><issn pub-type="ppub">0195-668X</issn><issn pub-type="epub">1522-9645</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1093/eurheartj/ehp601</article-id><article-id pub-id-type="publisher-id">ehp601</article-id><article-categories><subj-group subj-group-type="heading"><subject>CLINICAL RESEARCH</subject><subj-group><subject>Prevention</subject></subj-group></subj-group><series-title>editor's choice</series-title></article-categories><title-group><article-title>Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Stein</surname><given-names>Evan A.</given-names></name><xref ref-type="aff" rid="af1">1</xref><xref ref-type="corresp" rid="cor1">*</xref></contrib><contrib contrib-type="author"><name><surname>Roth</surname><given-names>Eli M.</given-names></name><xref ref-type="aff" rid="af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Rhyne</surname><given-names>James M.</given-names></name><xref ref-type="aff" rid="af3">3</xref></contrib><contrib contrib-type="author"><name><surname>Burgess</surname><given-names>Tracy</given-names></name><xref ref-type="aff" rid="af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Kallend</surname><given-names>David</given-names></name><xref ref-type="aff" rid="af5">5</xref></contrib><contrib contrib-type="author"><name><surname>Robinson</surname><given-names>Jennifer G.</given-names></name><xref ref-type="aff" rid="af6">6</xref></contrib></contrib-group><aff id="af1"><label>1</label><addr-line>Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212</addr-line>, <country>USA</country></aff><aff id="af2"><label>2</label><addr-line>Sterling Research Group, Cincinnati, OH</addr-line>, <country>USA</country></aff><aff id="af3"><label>3</label><addr-line>The Lipid Center, Statesville, NC</addr-line>, <country>USA</country></aff><aff id="af4"><label>4</label><addr-line>Hoffmann-La Roche Inc., Nutley, NJ</addr-line>, <country>USA</country></aff><aff id="af5"><label>5</label><addr-line>F. Hoffmann-La Roche Ltd, Basel</addr-line>, <country>Switzerland</country></aff><aff id="af6"><label>6</label><addr-line>Lipid Research Clinic</addr-line>, <institution>The University of Iowa</institution>, <addr-line>Iowa City, IA</addr-line>, <country>USA</country></aff><author-notes><corresp id="cor1"><label>*</label>Corresponding author. Tel: <phone>+1 513 579 8811 ext. 4222</phone>, Fax: <fax>+1 513 579 8832</fax>, Email: <email>esteinmrl@aol.com</email></corresp></author-notes><pub-date pub-type="ppub"><month>2</month><year>2010</year></pub-date><pub-date pub-type="epub"><day>22</day><month>1</month><year>2010</year></pub-date><volume>31</volume><issue>4</issue><fpage>480</fpage><lpage>488</lpage><history><date date-type="received"><day>4</day><month>6</month><year>2009</year></date><date date-type="rev-recd"><day>6</day><month>11</month><year>2009</year></date><date date-type="accepted"><day>8</day><month>12</month><year>2009</year></date></history><copyright-statement>Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2010. For permissions please email: journals.permissions@oxfordjournals.org.</copyright-statement><copyright-year>2010</copyright-year><license license-type="creative-commons" xlink:href="http://creativecommons.org/licenses/by-nc/2.0/uk/"><p>The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that the original authorship is properly and fully attributed; the Journal, Learned Society and Oxford University Press are attributed as the original place of publication with correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org.</p></license><related-article related-article-type="in-this-issue" xlink:href="10.1093/eurheartj/ehp394" vol="31" page="390" id="RA1" ext-link-type="doi"><bold>See page 390 for the editorial comment on this article (doi:10.1093/eurheartj/ehp394)</bold></related-article><abstract><sec><title>Aims</title><p>Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes.</p></sec><sec><title>Methods and results</title><p>Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (<italic>n</italic> = 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (<italic>n</italic> = 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4%, Week 24; 33.8%, Week 48), decreased CETP activity (–53.5%, Week 24; –56.5%, Week 48), and increased apolipoprotein A-I (11.4%, Week 24; 16.4%, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size.</p></sec><sec><title>Conclusion</title><p>Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment.</p></sec></abstract><kwd-group><kwd>CETP</kwd><kwd>Dalcetrapib</kwd><kwd>HDL-C</kwd><kwd>Lymph node</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><partName>editor's choice</partName><title>Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><partName>editor's choice</partName><title>Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial</title></titleInfo><name type="personal"><namePart type="given">Evan A.</namePart><namePart type="family">Stein</namePart><affiliation>Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212, USA</affiliation><affiliation>E-mail: esteinmrl@aol.com</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Eli M.</namePart><namePart type="family">Roth</namePart><affiliation>Sterling Research Group, Cincinnati, OH, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">James M.</namePart><namePart type="family">Rhyne</namePart><affiliation>The Lipid Center, Statesville, NC, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Tracy</namePart><namePart type="family">Burgess</namePart><affiliation>Hoffmann-La Roche Inc., Nutley, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David</namePart><namePart type="family">Kallend</namePart><affiliation>F. Hoffmann-La Roche Ltd, Basel, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jennifer G.</namePart><namePart type="family">Robinson</namePart><affiliation>Lipid Research Clinic, The University of Iowa, Iowa City, IA, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">2010-02</dateIssued><dateCreated encoding="w3cdtf">2010-01-22</dateCreated><copyrightDate encoding="w3cdtf">2010</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Aims Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. Methods and results Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4, Week 24; 33.8, Week 48), decreased CETP activity (53.5, Week 24; 56.5, Week 48), and increased apolipoprotein A-I (11.4, Week 24; 16.4, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. Conclusion Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment.</abstract><subject><genre>keywords</genre><topic>CETP</topic><topic>Dalcetrapib</topic><topic>HDL-C</topic><topic>Lymph node</topic></subject><relatedItem type="host"><titleInfo><title>European Heart Journal</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0195-668X</identifier><identifier type="eISSN">1522-9645</identifier><identifier type="PublisherID">eurheartj</identifier><identifier type="PublisherID-hwp">ehj</identifier><part><date>2010</date><detail type="volume"><caption>vol.</caption><number>31</number></detail><detail type="issue"><caption>no.</caption><number>4</number></detail><extent unit="pages"><start>480</start><end>488</end></extent></part></relatedItem><relatedItem type="reviewOf"><identifier type="doi">10.1093/eurheartj/ehp394</identifier><part><detail type="volume"><caption>vol.</caption><number>31</number></detail><extent unit="pages"><start>390</start></extent></part></relatedItem><identifier type="istex">C3BDE6B10833703DFF65A1644E90ABE7C6001361</identifier><identifier type="DOI">10.1093/eurheartj/ehp601</identifier><identifier type="ArticleID">ehp601</identifier><identifier type="Related-article-href">10.1093/eurheartj/ehp394</identifier><identifier type="related-article-ID">RA1</identifier><accessCondition type="use and reproduction" contentType="copyright">Published on behalf of the European Society of Cardiology. 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