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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe Action to Control Cardiovascular Risk in Diabetes [ACCORD] Lipid study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00000620\u0026amp;atom=%2Fspmdc%2F10%2F2%2F11.atom\u0022\u003ENCT00000620\u003C\/a\u003E] does not support the use of combination fibrate and statin therapy compared with statin therapy alone to reduce cardiovascular risk in high-risk patients with type 2 diabetes mellitus. However, subgroup analyses suggest a treatment interaction that is associated with combination therapy and gender and a possible interaction between combination therapy and severe dyslipidemia.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Elipid disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eprevention \u0026amp; screening clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ediabetes mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eprevention \u0026amp; screening\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EThe Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid study (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00000620\u0026amp;atom=%2Fspmdc%2F10%2F2%2F11.atom\u0022\u003ENCT00000620\u003C\/a\u003E) does not support the use of combination fibrate and statin therapy compared with statin therapy alone to reduce cardiovascular (CV) risk in high-risk patients with type 2 diabetes mellitus (DM). However, subgroup analyses suggest a treatment interaction that is associated with combination therapy and gender and a possible interaction between combination therapy and severe dyslipidemia.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EHenry N. Ginsberg, MD, Columbia University, New York, NY, discussed findings from the ACCORD Lipid Study. The lipid substudy was a randomized, placebo-controlled, double-blind trial that included 5518 participants with stable type 2 DM for \u0026gt;3 months who were at high risk for cardiovascular disease (CVD) events (defined as clinical or subclinical disease or having \u22652 risk factors in addition to type 2 DM; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). All patients were taking simvastatin 20 to 40 mg\/day and were randomized to receive either fenofibrate 54 to 160 mg\/day (based on estimated glomerular filtration rate) or placebo. The mean follow-up was 4.7 years.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11297\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11297\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11297\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-4\u0022 class=\u0022first-child\u0022\u003EAdditional Inclusion Criteria for the ACCORD Lipid Study.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe primary outcome was the first occurrence of a major CV event (defined as nonfatal myocardial infarction [MI], nonfatal stroke, or CV death). Secondary outcomes included the individual components of the primary outcome, an expanded macrovascular outcome (defined as a combination of the primary outcome plus revascularization or hospitalization for congestive heart failure), major coronary disease events (defined as a combination of a fatal coronary event, a nonfatal MI, or unstable angina), hospitalization or death due to heart failure, all stroke, and death from any cause.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EThere was no significant difference between fenofibrate and placebo for the primary outcome or the prespecified secondary outcomes. The most common adverse event was severe muscle aches\/pains, which was similar in both groups regardless of creatine kinase level (40% for both groups). Elevations of creatine kinase were unusual and not different between the two treatment groups. Other serious adverse events were uncommon. Both groups demonstrated increased serum creatinine levels over the course of the study, but the incidence of elevated creatinine was 50% to 100% higher in the fenofibrate group. In contrast to the increases in creatinine in the fenofibrate group, the incidence of both micro- and macroproteinuria was lower in participants who were treated with fenofibrate.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThere was evidence of an interaction between gender and fenofibrate + simvastatin combination therapy, suggesting a potential harm for women (9.1% event rate over five years for the fenofibrate group vs a 6.6% event rate over five years for the placebo group) and potential benefit for men (11.2% for fenofibrate vs 13.3% for placebo) with regard to the primary outcome of major CV events (p=0.01 for interaction). When patients with both low HDL levels (\u226434 mg\/dL) and high triglyceride levels (\u2265204 mg\/dL) were compared with all other participants, a weak heterogeneity was observed, but this interaction did not reach statistical significance (p=0.057 for interaction). However, there was a suggestion of benefit in the subgroup with severe dyslipidemia (12.37% for fenofibrate vs 17.32% for placebo); there was no benefit of fenofibrate in all other participants (10.11% for fenofibrate vs 10.11% for placebo).\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EWhile the primary endpoint was not achieved in the ACCORD Lipid study, the interactions that were noted during the subgroup analyses merit further investigation. Whether or not there are gender-specific differences in benefit that are associated with fenofibrate combination therapy has not been established. Additionally, the nonsignificant interaction that was detected in those with significant dyslipidemia requires clarification.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2010 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section ref-list\u0022 id=\u0022ref-list-1\u0022\u003E\u003Ch2 class=\u0022\u0022\u003EFurther Reading\u003C\/h2\u003E\u003Col class=\u0022cit-list ref-use-labels\u0022\u003E\u003Cli\u003E\u003Cspan class=\u0022ref-label ref-label-empty\u0022\u003E\u003C\/span\u003E\n            \u003Cdiv class=\u0022cit ref-cit ref-journal no-rev-xref\u0022 id=\u0022cit-10.2.11.1\u0022\u003E\u003Cdiv class=\u0022cit-metadata\u0022\u003E\u003Ccite\u003E\u003Cspan class=\u0022cit-article-title\u0022\u003EThe ACCORD Study\u003C\/span\u003E. \u003Cabbr class=\u0022cit-jnl-abbrev\u0022\u003EGroup N Engl J Med\n               \u003C\/abbr\u003E. \u003Cspan class=\u0022cit-pub-date\u0022\u003E2010\u003C\/span\u003E; published online ahead of print.\u003C\/cite\u003E\u003C\/div\u003E\u003Cdiv class=\u0022cit-extra\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003C\/li\u003E\u003C\/ol\u003E\u003C\/div\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/10\/2\/11.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzmt61\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzmt61\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}