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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\u003ERecent results from the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure [EMPHASIS-HF] trial showed that eplerenone, compared with placebo, significantly reduced the risk of the composite of cardiovascular death and hospitalization for heart failure in patients with chronic systolic NYHA class II HF [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00232180\u0026amp;atom=%2Fspmdc%2F11%2F10%2F14.atom\u0022\u003ENCT00232180\u003C\/a\u003E; Zannad F et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2011].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHeart Failure\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ERecent results from the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF) trial showed that eplerenone, compared with placebo, significantly reduced the risk of the composite of cardiovascular (CV) death and hospitalization for heart failure (HF) in patients with chronic systolic NYHA class II HF [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00232180\u0026amp;atom=%2Fspmdc%2F11%2F10%2F14.atom\u0022\u003ENCT00232180\u003C\/a\u003E; Zannad F et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2011]. Subjects were randomized to eplerenone (up to 50 mg daily) or placebo, in addition to recommended background therapy. Enrollment in the trial, which randomized 2737 patients, was stopped prematurely after a median follow-up of 21 months, when an overwhelming benefit (HR, 0.63; p\u0026lt;0.001) with eplerenone on the primary endpoint of death from CV causes and hospitalization for HF was observed in the secondary interim analysis. After the trial was prematurely stopped for efficacy in May 2010, a subgroup of patients (58% of the patients who were randomized; n=1597) were followed for an additional 10 months on blinded therapy through March 2011, resulting in a mean follow-up of 25 months in the extended follow-up subgroup.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EBertram Pitt, MD, University of Michigan, Ann Arbor, Michigan, USA, presented three sets of new data from the trial: 1) safety and efficacy results of the extended follow-up of the EMPHASIS-HF study; 2) an exploratory analysis of recurrent hospitalization; and 3) analyses in five high-risk subgroups. The five subgroups of individuals who were considered to be at high risk were independently analyzed, including subjects with: age \u226575 years (n=184), left ventricular ejection fraction (LVEF) \u0026lt;30% (n=440), estimated glomerular filtration rate (eGFR) \u0026lt;60 ml\/min\/1.73 m\u003Csup\u003E2\u003C\/sup\u003E (n=270), diabetes (n=240), and systolic blood pressure (SBP) \u0026lt;123 mm Hg (n=339).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EConsistent with the main study, the primary composite endpoint of CV death or hospitalization for HF was reduced with eplerenone compared with placebo (HR, 0.66; 95% CI, 0.57 to 0.77; p\u0026lt;0.001) in the extended follow-up subgroup. An analysis of the cumulative number of hospitalization for HF (recurrent event analysis) also favored eplerenone (HR, 0.62; 95% CI, 0.53 to 0.72; p\u0026lt;0.001).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThere were consistent reductions with eplerenone in the primary endpoint in each of the five individual high-risk groups (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Additionally, in each of the five subgroups, there were significant reductions with eplerenone in the secondary endpoints of all-cause hospitalization and in hospitalization for HF (p\u0026lt;0.01 for all comparisons).\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\/12441\/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\/12441\/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\/12441\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-6\u0022 class=\u0022first-child\u0022\u003ERates of CV Death or HF Hospitalization During Study Extension.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EThe safety endpoint of serum potassium greater than 5.5 mmol\/L was more frequent with eplerenone overall and among each of the individual high-risk groups (p\u0026lt;0.05 for each comparison). There was no significant increase in serious hyperkalemia (K+ \u0026gt;6.0 mmol\/L), hyperkalemia that led to drug discontinuation, hospitalization for hyperkalemia, or hospitalization for worsening renal function for eplerenone patients relative to placebo patients.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThese results showed a consistent benefit in the reduction of CV death or hospitalization for HF over continued follow-up and among individual high-risk subgroups. Important reductions were also seen in the secondary endpoints of all-cause hospitalization and in hospitalization for HF. While these results show compelling evidence for efficacy that is consistent with guideline recommendations for this class of medications, there were higher rates of hyperkalemia, and the study protocol required careful monitoring with visits every 4 months. This should be considered when applying these results with eplerenone in clinical practice.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 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\/11\/10\/14.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?nzmyrp\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?nzmyrp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}