ApoA-I Induction as a Potential Cardioprotective Strategy: Rationale for the SUSTAIN and ASSURE Studies
Background Considerable interest has focused on the development of therapies that target the functionality of high-density lipoproteins (HDL). Upregulation of endogenous synthesis of the major protein on HDL particles, apolipoprotein A-I (apoA-I), represents a novel approach to generation of new HDL...
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| Veröffentlicht in: | Cardiovascular drugs and therapy 2012-04, Vol.26 (2), p.181-187 |
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| creator | Nicholls, Stephen J. Gordon, Allan Johannson, Jan Ballantyne, Christie M. Barter, Philip J. Brewer, H. Bryan Kastelein, John J. P. Wong, Norman C. Borgman, Marilyn R. N. Nissen, Steven E. |
| description | Background
Considerable interest has focused on the development of therapies that target the functionality of high-density lipoproteins (HDL). Upregulation of endogenous synthesis of the major protein on HDL particles, apolipoprotein A-I (apoA-I), represents a novel approach to generation of new HDL particles. The Study of Quantitative Serial Trends in Lipids with Apolipoprotein A-I Stimulation (SUSTAIN, NCT01423188) study aims to evaluate the lipid efficacy, safety and tolerability of an apoA-I inducer (RVX-208). The ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation (ASSURE, NCT01067820) study aims to evaluate the effect of RVX-208 on plaque burden.
Methods
In SUSTAIN, 172 patients with low levels of HDL-C will be randomized to receive RVX-208 100 mg bid or placebo for 24 weeks. The primary efficacy parameter will be the percentage change in HDL-C levels. In ASSURE, 310 patients with angiographic coronary artery disease and low HDL-C levels will be randomized to receive RVX-208 100 mg bid or placebo for 26 weeks. The primary efficacy parameter will be the nominal change in percent atheroma volume (PAV), determined by analysis of intravascular ultrasound (IVUS) images of matched coronary artery segments acquired at baseline and at 26-week follow-up. The effect of RVX-208 on other lipid and inflammatory markers, safety and tolerability will also be assessed in both studies.
Conclusion
ApoA-I induction represents a potential novel strategy to reduce cardiovascular risk, by generating nascent HDL particles. These studies will provide early evaluation of the effects of RVX-208 on lipids and atherosclerotic plaque. |
| doi_str_mv | 10.1007/s10557-012-6373-5 |
| format | Article |
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Considerable interest has focused on the development of therapies that target the functionality of high-density lipoproteins (HDL). Upregulation of endogenous synthesis of the major protein on HDL particles, apolipoprotein A-I (apoA-I), represents a novel approach to generation of new HDL particles. The Study of Quantitative Serial Trends in Lipids with Apolipoprotein A-I Stimulation (SUSTAIN, NCT01423188) study aims to evaluate the lipid efficacy, safety and tolerability of an apoA-I inducer (RVX-208). The ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation (ASSURE, NCT01067820) study aims to evaluate the effect of RVX-208 on plaque burden.
Methods
In SUSTAIN, 172 patients with low levels of HDL-C will be randomized to receive RVX-208 100 mg bid or placebo for 24 weeks. The primary efficacy parameter will be the percentage change in HDL-C levels. In ASSURE, 310 patients with angiographic coronary artery disease and low HDL-C levels will be randomized to receive RVX-208 100 mg bid or placebo for 26 weeks. The primary efficacy parameter will be the nominal change in percent atheroma volume (PAV), determined by analysis of intravascular ultrasound (IVUS) images of matched coronary artery segments acquired at baseline and at 26-week follow-up. The effect of RVX-208 on other lipid and inflammatory markers, safety and tolerability will also be assessed in both studies.
Conclusion
ApoA-I induction represents a potential novel strategy to reduce cardiovascular risk, by generating nascent HDL particles. These studies will provide early evaluation of the effects of RVX-208 on lipids and atherosclerotic plaque.</description><identifier>ISSN: 0920-3206</identifier><identifier>EISSN: 1573-7241</identifier><identifier>DOI: 10.1007/s10557-012-6373-5</identifier><identifier>PMID: 22349989</identifier><identifier>CODEN: CDTHET</identifier><language>eng</language><publisher>Boston: Springer US</publisher><subject>Adolescent ; Apolipoprotein A-I - biosynthesis ; Apolipoprotein A-I - metabolism ; Atherosclerosis (general aspects, experimental research) ; Biological and medical sciences ; Blood and lymphatic vessels ; Cardiology ; Cardiology. Vascular system ; Cardiotonic Agents - metabolism ; Cardiovascular system ; Cholesterol, HDL - metabolism ; Coronary Angiography - methods ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - drug therapy ; Coronary heart disease ; Coronary Vessels - drug effects ; Coronary Vessels - metabolism ; Female ; Follow-Up Studies ; Heart ; Humans ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Pharmacology. Drug treatments ; Plaque, Atherosclerotic - drug therapy ; Plaque, Atherosclerotic - metabolism ; Quinazolines - therapeutic use ; Ultrasonography</subject><ispartof>Cardiovascular drugs and therapy, 2012-04, Vol.26 (2), p.181-187</ispartof><rights>Springer Science+Business Media, LLC 2012</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c466t-83c6d29c18fd0c5e3d85a4e66a81186315e0015f0a29c5c2dd291ee378c421b03</citedby><cites>FETCH-LOGICAL-c466t-83c6d29c18fd0c5e3d85a4e66a81186315e0015f0a29c5c2dd291ee378c421b03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10557-012-6373-5$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10557-012-6373-5$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25761285$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22349989$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nicholls, Stephen J.</creatorcontrib><creatorcontrib>Gordon, Allan</creatorcontrib><creatorcontrib>Johannson, Jan</creatorcontrib><creatorcontrib>Ballantyne, Christie M.</creatorcontrib><creatorcontrib>Barter, Philip J.</creatorcontrib><creatorcontrib>Brewer, H. Bryan</creatorcontrib><creatorcontrib>Kastelein, John J. P.</creatorcontrib><creatorcontrib>Wong, Norman C.</creatorcontrib><creatorcontrib>Borgman, Marilyn R. N.</creatorcontrib><creatorcontrib>Nissen, Steven E.</creatorcontrib><title>ApoA-I Induction as a Potential Cardioprotective Strategy: Rationale for the SUSTAIN and ASSURE Studies</title><title>Cardiovascular drugs and therapy</title><addtitle>Cardiovasc Drugs Ther</addtitle><addtitle>Cardiovasc Drugs Ther</addtitle><description>Background
Considerable interest has focused on the development of therapies that target the functionality of high-density lipoproteins (HDL). Upregulation of endogenous synthesis of the major protein on HDL particles, apolipoprotein A-I (apoA-I), represents a novel approach to generation of new HDL particles. The Study of Quantitative Serial Trends in Lipids with Apolipoprotein A-I Stimulation (SUSTAIN, NCT01423188) study aims to evaluate the lipid efficacy, safety and tolerability of an apoA-I inducer (RVX-208). The ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation (ASSURE, NCT01067820) study aims to evaluate the effect of RVX-208 on plaque burden.
Methods
In SUSTAIN, 172 patients with low levels of HDL-C will be randomized to receive RVX-208 100 mg bid or placebo for 24 weeks. The primary efficacy parameter will be the percentage change in HDL-C levels. In ASSURE, 310 patients with angiographic coronary artery disease and low HDL-C levels will be randomized to receive RVX-208 100 mg bid or placebo for 26 weeks. The primary efficacy parameter will be the nominal change in percent atheroma volume (PAV), determined by analysis of intravascular ultrasound (IVUS) images of matched coronary artery segments acquired at baseline and at 26-week follow-up. The effect of RVX-208 on other lipid and inflammatory markers, safety and tolerability will also be assessed in both studies.
Conclusion
ApoA-I induction represents a potential novel strategy to reduce cardiovascular risk, by generating nascent HDL particles. These studies will provide early evaluation of the effects of RVX-208 on lipids and atherosclerotic plaque.</description><subject>Adolescent</subject><subject>Apolipoprotein A-I - biosynthesis</subject><subject>Apolipoprotein A-I - metabolism</subject><subject>Atherosclerosis (general aspects, experimental research)</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Cardiology</subject><subject>Cardiology. Vascular system</subject><subject>Cardiotonic Agents - metabolism</subject><subject>Cardiovascular system</subject><subject>Cholesterol, HDL - metabolism</subject><subject>Coronary Angiography - methods</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - drug therapy</subject><subject>Coronary heart disease</subject><subject>Coronary Vessels - drug effects</subject><subject>Coronary Vessels - metabolism</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Pharmacology. Drug treatments</subject><subject>Plaque, Atherosclerotic - drug therapy</subject><subject>Plaque, Atherosclerotic - metabolism</subject><subject>Quinazolines - therapeutic use</subject><subject>Ultrasonography</subject><issn>0920-3206</issn><issn>1573-7241</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kdFrFDEQxoMo9qz-Ab5IEIpPq5lkk836thy1HhSVXu85TJPsuWVv90x2hf73znFXC4JPGTK_75tJPsbegvgIQlSfMgitq0KALIyqVKGfsQVoKipZwnO2ELUUhZLCnLFXOd8L0tS1fcnOpFQlVfWCbZv92BQrvhrC7KduHDhmjvzHOMVh6rDnS0yhG_eJLqj_O_L1lHCK24fP_AYPAuwjb8fEp5_U26xvm9U3jkPgzXq9ubkkfA5dzK_Zixb7HN-cznO2-XJ5u_xaXH-_Wi2b68KXxkyFVd4EWXuwbRBeRxWsxjIagxbAGgU6CgG6FUiQ9jIQDDGqyvpSwp1Q5-zD0Zc2_jXHPLldl33sexziOGdXG1Vaa6Ai8v0_5P04J3oOQdpKLcmZIDhCPo05p9i6fep2mB4cCHfIwB0zcJSBO2TgNGnenYznu10MfxWPn07AxQnA7LFvEw6-y0-crgxIezCSRy5Ta9jG9LTh_6f_ASlMnCo</recordid><startdate>20120401</startdate><enddate>20120401</enddate><creator>Nicholls, Stephen J.</creator><creator>Gordon, Allan</creator><creator>Johannson, Jan</creator><creator>Ballantyne, Christie M.</creator><creator>Barter, Philip J.</creator><creator>Brewer, H. Bryan</creator><creator>Kastelein, John J. P.</creator><creator>Wong, Norman C.</creator><creator>Borgman, Marilyn R. N.</creator><creator>Nissen, Steven E.</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20120401</creationdate><title>ApoA-I Induction as a Potential Cardioprotective Strategy: Rationale for the SUSTAIN and ASSURE Studies</title><author>Nicholls, Stephen J. ; Gordon, Allan ; Johannson, Jan ; Ballantyne, Christie M. ; Barter, Philip J. ; Brewer, H. Bryan ; Kastelein, John J. P. ; Wong, Norman C. ; Borgman, Marilyn R. N. ; Nissen, Steven E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c466t-83c6d29c18fd0c5e3d85a4e66a81186315e0015f0a29c5c2dd291ee378c421b03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Apolipoprotein A-I - biosynthesis</topic><topic>Apolipoprotein A-I - metabolism</topic><topic>Atherosclerosis (general aspects, experimental research)</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Cardiology</topic><topic>Cardiology. Vascular system</topic><topic>Cardiotonic Agents - metabolism</topic><topic>Cardiovascular system</topic><topic>Cholesterol, HDL - metabolism</topic><topic>Coronary Angiography - methods</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - drug therapy</topic><topic>Coronary heart disease</topic><topic>Coronary Vessels - drug effects</topic><topic>Coronary Vessels - metabolism</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Pharmacology. Drug treatments</topic><topic>Plaque, Atherosclerotic - drug therapy</topic><topic>Plaque, Atherosclerotic - metabolism</topic><topic>Quinazolines - therapeutic use</topic><topic>Ultrasonography</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nicholls, Stephen J.</creatorcontrib><creatorcontrib>Gordon, Allan</creatorcontrib><creatorcontrib>Johannson, Jan</creatorcontrib><creatorcontrib>Ballantyne, Christie M.</creatorcontrib><creatorcontrib>Barter, Philip J.</creatorcontrib><creatorcontrib>Brewer, H. Bryan</creatorcontrib><creatorcontrib>Kastelein, John J. P.</creatorcontrib><creatorcontrib>Wong, Norman C.</creatorcontrib><creatorcontrib>Borgman, Marilyn R. N.</creatorcontrib><creatorcontrib>Nissen, Steven E.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Cardiovascular drugs and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nicholls, Stephen J.</au><au>Gordon, Allan</au><au>Johannson, Jan</au><au>Ballantyne, Christie M.</au><au>Barter, Philip J.</au><au>Brewer, H. Bryan</au><au>Kastelein, John J. P.</au><au>Wong, Norman C.</au><au>Borgman, Marilyn R. N.</au><au>Nissen, Steven E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>ApoA-I Induction as a Potential Cardioprotective Strategy: Rationale for the SUSTAIN and ASSURE Studies</atitle><jtitle>Cardiovascular drugs and therapy</jtitle><stitle>Cardiovasc Drugs Ther</stitle><addtitle>Cardiovasc Drugs Ther</addtitle><date>2012-04-01</date><risdate>2012</risdate><volume>26</volume><issue>2</issue><spage>181</spage><epage>187</epage><pages>181-187</pages><issn>0920-3206</issn><eissn>1573-7241</eissn><coden>CDTHET</coden><abstract>Background
Considerable interest has focused on the development of therapies that target the functionality of high-density lipoproteins (HDL). Upregulation of endogenous synthesis of the major protein on HDL particles, apolipoprotein A-I (apoA-I), represents a novel approach to generation of new HDL particles. The Study of Quantitative Serial Trends in Lipids with Apolipoprotein A-I Stimulation (SUSTAIN, NCT01423188) study aims to evaluate the lipid efficacy, safety and tolerability of an apoA-I inducer (RVX-208). The ApoA-I Synthesis Stimulation and Intravascular Ultrasound for Coronary Atheroma Regression Evaluation (ASSURE, NCT01067820) study aims to evaluate the effect of RVX-208 on plaque burden.
Methods
In SUSTAIN, 172 patients with low levels of HDL-C will be randomized to receive RVX-208 100 mg bid or placebo for 24 weeks. The primary efficacy parameter will be the percentage change in HDL-C levels. In ASSURE, 310 patients with angiographic coronary artery disease and low HDL-C levels will be randomized to receive RVX-208 100 mg bid or placebo for 26 weeks. The primary efficacy parameter will be the nominal change in percent atheroma volume (PAV), determined by analysis of intravascular ultrasound (IVUS) images of matched coronary artery segments acquired at baseline and at 26-week follow-up. The effect of RVX-208 on other lipid and inflammatory markers, safety and tolerability will also be assessed in both studies.
Conclusion
ApoA-I induction represents a potential novel strategy to reduce cardiovascular risk, by generating nascent HDL particles. These studies will provide early evaluation of the effects of RVX-208 on lipids and atherosclerotic plaque.</abstract><cop>Boston</cop><pub>Springer US</pub><pmid>22349989</pmid><doi>10.1007/s10557-012-6373-5</doi><tpages>7</tpages></addata></record> |
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| subjects | Adolescent Apolipoprotein A-I - biosynthesis Apolipoprotein A-I - metabolism Atherosclerosis (general aspects, experimental research) Biological and medical sciences Blood and lymphatic vessels Cardiology Cardiology. Vascular system Cardiotonic Agents - metabolism Cardiovascular system Cholesterol, HDL - metabolism Coronary Angiography - methods Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - drug therapy Coronary heart disease Coronary Vessels - drug effects Coronary Vessels - metabolism Female Follow-Up Studies Heart Humans Male Medical sciences Medicine Medicine & Public Health Pharmacology. Drug treatments Plaque, Atherosclerotic - drug therapy Plaque, Atherosclerotic - metabolism Quinazolines - therapeutic use Ultrasonography |
| title | ApoA-I Induction as a Potential Cardioprotective Strategy: Rationale for the SUSTAIN and ASSURE Studies |
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