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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003EResults from the Simvastatin and Ezetimibe in Aortic Stenosis [SEAS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00092677\u0026amp;atom=%2Fspmdc%2F8%2F6%2F25.atom\u0022\u003ENCT00092677\u003C\/a\u003E] study indicate that intensive LDL-cholesterol-lowering with the combination of simvastatin 40 mg and ezetimibe 10 mg does not affect the progression of aortic valve stenosis, but can reduce the risk of cardiovascular ischemic events in subjects with mild-to-moderate asymptomatic aortic stenosis, when compared with placebo.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Evalvular disease clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Elipid disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EResults from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00092677\u0026amp;atom=%2Fspmdc%2F8%2F6%2F25.atom\u0022\u003ENCT00092677\u003C\/a\u003E) study indicate that intensive LDL-cholesterol (LDL-C)-lowering with the combination of simvastatin 40 mg and ezetimibe 10 mg does not affect the progression of aortic valve stenosis, but can reduce the risk of cardiovascular ischemic events in subjects with mild-to-moderate asymptomatic aortic stenosis (AS), when compared with placebo.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EAS is a relatively common disease among elderly people and, if left untreated, can progress to death from heart failure or cardiac arrest. The standard treatment is valve replacement. There are no pharmacological therapies to prevent or treat this condition. Several studies have indicated that the cellular mechanism that is involved in the progression of AS may be similar to that of atherosclerosis [Rajamannan NM et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2002; 2003; 2005; \u003Cem\u003ENat Clin Practi Cardiovasc Med 2007\u003C\/em\u003E]; however, the results of one small prospective study that examined the effect of lipid-lowering on the progression of AS failed to find any effect [Cowell SJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2005].\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe objective of the SEAS study was to evaluate the effect of long-term, intensive cholesterol-lowering on clinical and echocardiographic outcomes in subjects with AS. The primary study endpoint was major cardiovascular events, a composite that consisted of death from cardiovascular causes, aortic valve replacement, congestive heart failure (CHF) resulting from the progression of AS, nonfatal myocardial infarction (MI), hospitalization for unstable angina, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and nonhemorrhagic stroke. Key secondary outcomes included aortic valve events (eg, aortic valve replacement surgery, CHF due to aortic valve stenosis, or death from cardiovascular causes); ischemic events (death from cardiovascular causes, nonfatal MI, hospitalization for unstable angina, CABG, PCI, or hemorrhagic stroke), progression of AS as seen by echocardiography, and drug safety.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe study population included 1873 men and women aged 45 to 85 years (mean 67 years) with asymptomatic, echocardiographically confirmed mild-to-moderate aortic valve stenosis (mean aortic valve area of 1.28\u00b10.47 cm\u003Csup\u003E2\u003C\/sup\u003E, with a mean and peak gradient of 23 and 39 mm Hg, respectively) and no other condition that was an indication for lipid-lowering therapy. After a diet run-in period of 4 weeks, subjects were randomly assigned to receive a combination of 40 mg simvastatin + 10 mg ezetimibe (n=944) or placebo (n=929). Subjects were followed for a minimum of 4 years; the median follow-up period was 52.2 months.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EAt Week 8, combination treatment with simvastatin\/ezetimibe resulted in a 61% decrease from baseline LDL-C levels (140\u00b136 mg\/dL to 53\u00b123 mg\/dL) compared with no change in the placebo group.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThe SEAS study found no difference between the simvastatin\/ezetimibe and placebo groups for the primary endpoint (HR 0.96; 95% CI, 0.83 to 1.12; p=0.59) or for the secondary outcome measures that were associated with aortic valve disease events (HR 0.97; 95% CI, 0.83 to 1.14; p=0.73). In contrast, significantly fewer subjects in the combination group experienced ischemic cardiovascular events versus those in the placebo group (148 [15.7%] vs 187 [20.1%]; HR 0.78, 95% CI, 0.63 to 0.97; p=0.024; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E), a difference that primarily was driven by a lower incidence of CABG in the combination group (69 [7.3%] vs 100 [10.8%]; HR 0.68; 95% CI, 0.50 to 0.93; p=0.015; \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E). There was no difference between the two groups in any of the other components of the secondary endpoint.\u003C\/p\u003E\n         \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\/8\/6\/25\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Kaplan-Meier Curve for Secondary Outcome of Ischemic Cardiovascular Events.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1881590849\u0022 data-figure-caption=\u0022Kaplan-Meier Curve for Secondary Outcome of Ischemic Cardiovascular Events.\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\/8\/6\/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\/8\/6\/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\/8\/6\/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\/11114\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\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EKaplan-Meier Curve for Secondary Outcome of Ischemic Cardiovascular Events.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cdiv id=\u0022F2\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\/8\/6\/25\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022CABG Intention to Treat Population: Percentage of Patients with First Event.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1881590849\u0022 data-figure-caption=\u0022CABG Intention to Treat Population: Percentage of Patients with First Event.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/8\/6\/25\/F2.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\/8\/6\/25\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\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\/8\/6\/25\/F2.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\/11118\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\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003ECABG Intention to Treat Population: Percentage of Patients with First Event.\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-10\u0022\u003EA significant difference was found in the incidence of cancer between treatment and placebo groups. Cancer was diagnosed in 11.1% (n=105) of subjects who received combination treatment versus 7.5% (n=70) subjects in the placebo group (p=0.01). Deaths from cancer also were more frequent in the ezetimibe\/simvastatin group compared with placebo (39 [4.1%] vs 23 [2.5%], HR 1.67; 95% CI, 1.00 to 2.79; p=0.05). The cancers were not concentrated in any particular site.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EThe incidence of other serious adverse events was similar between the two groups, with the exception of liver enzymes. Significantly more subjects in the combination group had liver enzyme levels \u0026gt;3X ULN (16\/925; 1.7%) versus in the placebo group (5\/915; 0.5%; p=0.03).\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EIn his discussion of the trial, Eugene Braunwald, MD, Brigham \u0026amp; Women\u0027s Hospital, Boston, MA, concluded that the SEAS study clearly demonstrated that the use of intensive lipid-lowering therapy with the combination simvastatin\/ezetimibe does not prevent the progression of AS in patients with mild-to-moderate disease. A significant reduction of ischemic cardiovascular events was observed, however, which were mostly associated with reduced CABG. This reduction was seen as compared with placebo; there was no active control treatment arm. Dr. Braunwald felt that the finding of increased cancer in patients who were treated with simvastatin\/ezetimibe was simply hypothesis-generating and commented that it was not confirmed by an analysis of data from 20,617 patients who were enrolled in the ongoing IMPROVE-IT (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00202878\u0026amp;atom=%2Fspmdc%2F8%2F6%2F25.atom\u0022\u003ENCT00202878\u003C\/a\u003E) and SHARP (\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00125593\u0026amp;atom=%2Fspmdc%2F8%2F6%2F25.atom\u0022\u003ENCT00125593\u003C\/a\u003E) trials. This analysis did not show a significant excess risk of cancer in the active treatment (313 deaths) versus control (326 deaths) arm (risk ratio 0.96; 95% CI, 0.82 to 1.12; p=0.61) [Peto R et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2008].\u003C\/p\u003E\n         \u003Cdiv id=\u0022F3\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\/8\/6\/25\/F3.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The editors would like to thank the many members of the ESC 2008 presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1881590849\u0022 data-figure-caption=\u0022The editors would like to thank the many members of the ESC 2008 presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure3\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/8\/6\/25\/F3.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\/8\/6\/25\/F3.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure3\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\/8\/6\/25\/F3.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\/11121\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\u0022\u003E\n               \u003Cp id=\u0022p-13\u0022 class=\u0022first-child\u0022\u003EThe editors would like to thank the many members of the ESC 2008 presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2008 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\/8\/6\/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?nzmd8q\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?nzmd8q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}