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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\u003Cp id=\u0022p-1\u0022\u003EAtrial fibrillation (AF) becomes more common with increasing age. Data from an unpublished new analysis of the Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48] support edoxaban as an alternative treatment to warfarin in elderly patients who require anticoagulation therapy. This article discusses a prespecified analysis that evaluated the association of age on study outcomes and the efficacy and safety of edoxaban relative to warfarin in the elderly with AF.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EENGAGE-AF TIMI-48\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Earrhythmias\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EAtrial fibrillation (AF) becomes more common with increasing age. Elderly patients are at greater risk of stroke while having a higher bleeding risk with anticoagulation. Data from an unpublished new analysis of the Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ENGAGE AF-TIMI 48; Giugliano RP et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2013] support edoxaban as an alternative treatment to warfarin in elderly patients who require anticoagulation therapy, stated Eri Toda Kato, MD, PhD, TIMI Study Group, Boston, Massachusetts, USA. She presented a prespecified analysis that evaluated the association of age on study outcomes and the efficacy and safety of edoxaban relative to warfarin in the elderly with AF.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe ENGAGE AF-TIMI 48 trial [Giugliano RP et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2013] established the noninferiority of high-dose edoxaban (HDE; 60 mg) and low-dose edoxaban (LDE; 30 mg) to warfarin for the primary outcome of stroke and systemic embolic event (SEE) in 21 105 patients with nonvalvular AF and a CHADS\u003Csub\u003E2\u003C\/sub\u003E score \u2265 2. The edoxaban dose was halved for patients having a creatinine clearance between 30 and 50 mL\/min or a body weight \u2264 60 kg or for those taking potent P-glycoprotein inhibitors.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003ETheir key characteristics in the prespecified age categories for the new analyses are detailed in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\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\/15165\/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\/15165\/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\/15165\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 \u003Cp id=\u0022p-5\u0022 class=\u0022first-child\u0022\u003EPatient Characteristics by Age in ENGAGE AF-TIMi 48\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EThe association of age on outcomes was determined by examining the event rate in the warfarin group, which eliminated the possible influence of the edoxaban dose adjustment. This analysis revealed a significant linear association between age and stroke\/SEE, ischemic stroke (IS), International Society of Thrombosis and Haemostasis (ISTH) major bleeding criteria, and intracranial hemorrhage (ICH; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001 for all). In the \u2265 75 and \u0026lt; 65 age groups, the absolute risk difference was 4% for stroke\/SEE and 8% for ISTH at 3 years (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001 for both), underscoring the strong relation between age and risk, which was amplified for bleeding.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe risk of events was increased with age for all outcomes and all treatments (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). HDE provided a greater reduction in ICH in patients aged \u0026gt; 65 years, while HDE and warfarin had a similar effect on stroke, SEE, IS, major bleeding, and ICH in most other groups. LDE reduced major bleeding and ICH but increased this risk of stroke\/SEE and IS. There was no evidence that age modified the effectiveness of treatment with edoxaban on stroke\/SEE or any other outcome (\u003Cem\u003EP\u003C\/em\u003E\n            \u003Csub\u003EInteraction\u003C\/sub\u003E \u0026gt; .05).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/52\/25\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Risk of Events by Age and Treatment in ENGAGE AF-TIMI 48\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-511551022\u0022 data-figure-caption=\u0022Risk of Events by Age and Treatment in ENGAGE AF-TIMI 48\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/52\/25\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/52\/25\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/52\/25\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15208\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\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003ERisk of Events by Age and Treatment in ENGAGE AF-TIMI 48\u003C\/p\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EENAGE AF-TIMI 48, Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation; HDE, high-dose edoxaban; ICH, intracranial hemorrhage; LDE, low-dose edoxaban; SEE, systemic embolic event; W, warfarin.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from ET Kato, MD, PhD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EIn the efficacy analysis of edoxaban vs warfarin, the absolute risk reduction (ARR) showed that HDE reduced stroke\/SEE in all age groups but was more pronounced in patients aged \u2265 75 years (\u221240 events per 10000 patient-years vs \u22126 and \u221220 for the \u0026lt; 65 and 65\u201374 age groups). It also reduced ICH in patients aged \u2265 75 years but not the other age groups (\u221218 events per 10 000 patient-years vs +2 and +17 for the \u0026lt; 65 and 65\u201374 age groups). LDE did not reduce stroke\/SEE or IS.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EThe safety analysis showed a dramatic ARR with HDE and LDE for ISTH major bleeding in all age groups and for ICH in patients aged \u0026gt; 65 years (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T2\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\/15209\/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\/15209\/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\/15209\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 2.\u003C\/span\u003E \u003Cp id=\u0022p-13\u0022 class=\u0022first-child\u0022\u003ESafety Analysis: Absolute Risk Reduction With Edoxaban vs Warfarin\u003Csup\u003E\u003Csup\u003Ea\u003C\/sup\u003E\u003C\/sup\u003E\n               \u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-16\u0022\u003EThe prespecified primary net clinical outcome (approved by the Food and Drug Administration when designing the trial) comprising stroke\/SEE, major bleeding, or all-cause death was reduced with HDE and LDE in all age groups, with a more marked ARR in the \u2265 75 age group (\u2212144 and \u2212251, respectively, vs \u22125 and \u221235 for the \u0026lt; 65 age group and \u221293 and \u221290 for the 65\u201374 age group).\u003C\/p\u003E\u003Cp id=\u0022p-17\u0022\u003EIn conclusion, this analysis from ENGAGE-TIMI 48 showed that increasing age was associated with the risk of stroke\/SEE, IS, ISTH major bleeding, and ICH and that the increased risk for ISTH major bleeding and ICH were more marked. Age did not affect outcomes with edoxaban vs warfarin. Edoxaban reduced the absolute risk of ISTH major bleeding and ICH and provided a superior net clinical benefit vs warfarin by decreasing the bleeding risk, particularly in patients aged \u2265 75 years. The absolute benefits with edoxaban vs warfarin were greater in patients aged \u2265 75 years because of their higher risk for stroke and bleeding.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\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\/14\/52\/25.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_figures.js?nzodgp\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_openurl.js?nzodgp\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?nzodgp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}