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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\u003EThis article discusses two analyses from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes study [RECORD; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00379769\u0026amp;atom=%2Fspmdc%2F9%2F4%2F21.atom\u0022\u003ENCT00379769\u003C\/a\u003E; Home PD et al. \u003Cem\u003ELancet\u003C\/em\u003E 2009] of cardiovascular outcomes in patients who were treated with rosiglitazone.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ETwo analyses from the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00379769\u0026amp;atom=%2Fspmdc%2F9%2F4%2F21.atom\u0022\u003ENCT00379769\u003C\/a\u003E; Home PD et al. \u003Cem\u003ELancet\u003C\/em\u003E 2009] of cardiovascular (CV) outcomes in patients who were treated with rosiglitazone were presented at the European Society of Cardiology 2009 Annual Congress. The first evaluated rates of CV death or CV hospitalization, and the second evaluated rates of coronary events.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe first analysis showed no difference in the primary endpoint of CV hospitalization or CV death but did demonstrate increased rates of heart failure (HF) that led to hospitalization or death in subjects who were randomized to rosiglitazone plus metformin or a sulfonylurea (RSG) compared with a control group that was treated with a combination of metformin and a sulfonylurea.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EProfessor Michel Komajda, MD, Universit\u00e9 Pierre et Marie Curie, France, Paris, presented the results of the post hoc analysis, showing that over the 5.5 years of follow-up in the RECORD study, subjects in the RSG group experienced similar rates of the primary endpoint (HR, 0.99; 95% CI, 0.85 to 1.16; p=0.93) compared with those on control, meeting the criteria for noninferiority. There were, however, significantly more fatal\/nonfatal HF events in the RSG group (61 events in the RSG group vs 29 in the control group; HR, 2.10; 95% CI, 1.35 to 3.27; p = 0.001). The HF event rates for the two groups began to diverge early and continued to diverge throughout the trial.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EFive baseline variables were shown to be significant predictors of HF risk: treatment with rosiglitazone (HR, 2.25; 95% CI, 1.42 to 3.58), age \u226560 years (HR, 3.81; 95% CI, 2.34 to 6.20), waist circumference \u2265104 cm (HR, 3.52; 95% CI, 2.08 to 5.98), the presence of microalbuminuria\/proteinuria (HR, 3.35; 95% CI, 2.18 to 5.14; all p\u0026lt;0.001), and baseline beta-blocker therapy (HR, 1.86; 95% CI, 1.20 to 2.90; p=0.006).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003E\u201cThese findings support the current recommendation that rosiglitazone should not be used in patients with symptomatic HF and should not continue to be used in the presence of HF,\u201d said Prof. Komajda. Professor Kenneth Dickstein, MD, Stavanger University Hospital, Stavanger, Norway, the discussant for the presentation, noted that subjects with a history of treatment for HF were excluded from RECORD and that use of RSG in such patients also should be avoided.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EA second analysis by Home et al. \u003Cem\u003E(Lancet\u003C\/em\u003E 2009) also evaluated the first occurrence of MI as an endpoint and showed no difference between the RSG group and the control (HR, 1.14; 95% CI, 0.80 to 1.63) from the RECORD trial. Professor John McMurray, University of Glasgow, Glasgow, Scotland, presented results of a post hoc analysis that was focused on more broadly defined coronary events, including an analysis of time to the first of three expanded coronary endpoints in the overall trial cohort, total (including recurrent) events, and events that occurred among those subjects who experienced a \u201cfirst MI\u201d during the trial. The three additional composite outcomes were: any acute coronary syndrome ([ACS], defined as fatal MI, sudden death, or hospitalization for cardiac arrest, acute MI, or unstable angina [UA] pectoris); any ACS or hospitalization with \u201cother\u201d angina (defined as ACS plus \u201cother\u201d CV hospitalization attributed to angina pectoris); and any ACS, \u201cother angina,\u201d or coronary revascularization.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003ESimilar to the results of the MI analysis in the RECORD study, no difference was observed between the RSG group and the control group for any of the newly analyzed composite outcomes (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThere were a total of 15 deaths in the RSG group (7 acute MI; 8 sudden cardiac deaths) versus 22 in the control group (10 acute MI; 12 sudden cardiac deaths). Total coronary events (cardiac arrest, acute MI, UA, other angina, or revascularization) also were similar between groups, wherein 221 events were experienced by 127 subjects in the RSG group versus 230 events in 128 subjects in the control group. Overall numbers of recurrent events in subjects who had a first MI also did not differ between treatment groups. Among the 60 survivors of a first MI in the RSG group, there were 7 recurrent MIs, 3 cases of UA, and 11 deaths (7 CV deaths). Among the 52 survivors of a first MI in the control group, there were 11 recurrent MIs, 2 cases of UA, and 12 deaths (10 CV deaths).\u003C\/p\u003E\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\/11362\/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\/11362\/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\/11362\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-10\u0022 class=\u0022first-child\u0022\u003ETime-to-First Event Composites.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-12\u0022\u003E\u201cIn the RECORD trial, contrary to the meta analysis published by Nissen and Wolski [Nissen SE and Wolski K. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2007],\u201d said Prof. McMurray, \u201cwe did not see statistically significant increase in coronary outcomes, an excess of recurrent coronary events, or an excess of total or cardiovascular mortality in subjects treated with rosiglitazone compared with those receiving conventional therapy.\u201d\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2009 MD Conference Express\u003C\/li\u003E\u003C\/ul\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\/9\/4\/21.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?nzmj61\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?nzmj61\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}