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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\u003ERosuvastatin did not improve cardiovascular morbidity and mortality in patients who had end-stage renal disease and who were on hemodialysis, according to results of the large, randomized, placebo-controlled A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular hemodialysis: an Assessment of Survival and Cardiovascular Events [AURORA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00240331\u0026amp;atom=%2Fspmdc%2F9%2F2%2F14.atom\u0022\u003ENCT00240331\u003C\/a\u003E] trial. There was no difference between rosuvastatin 10 mg and placebo in reducing the combined endpoint of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction or any of the individual components of this endpoint when analyzed separately.\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\u003ELipid Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ERosuvastatin did not improve cardiovascular morbidity and mortality in patients who had end-stage renal disease (ESRD) and who were on hemodialysis, according to results of the large, randomized, placebo-controlled AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular hemodialysis: an Assessment of survival and cardiovascular events; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00240331\u0026amp;atom=%2Fspmdc%2F9%2F2%2F14.atom\u0022\u003ENCT00240331\u003C\/a\u003E) trial. There was no difference between rosuvastatin 10 mg and placebo in reducing the combined endpoint of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction (MI) or any of the individual components of this endpoint when analyzed separately. The results were presented by Bengt Fellstr\u00f6m, MD, University Hospital, Uppsala, Sweden [Fellstr\u00f6m B et al. \u003Cem\u003ENew Engl J Med\u003C\/em\u003E 2009].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EA number of studies have shown that statins lower the incidence of cardiovascular events in high-risk patients; however, it was unknown if they would have a similar effect in patients with ESRD who were on hemodialysis. A previous study with atorvastatin failed to demonstrate that statins have a statistically significant effect in reducing cardiovascular events in diabetic patients on hemodialysis with ESRD [Wanner C et al. \u003Cem\u003ENew Engl J Med\u003C\/em\u003E 2005].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EResults from AURORA showed no statistically significant difference between the rosuvastatin 10 mg daily group and the placebo group in the primary endpoint of major cardiovascular event (defined as cardiovascular death, nonfatal MI, or nonfatal stroke). A major cardiovascular event occurred in 396 rosuvastatin-treated subjects and 408 subjects who received placebo (HR, 0.96; 95% CI, 0.84 to 1.11; p=0.59; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). There were no statistically significant differences in any of the secondary endpoints, including any death (p=0.51), noncardiovascular death (p=0.34), major cardiovascular event-\/cause-specific death (p=0.30), atherosclerotic cardiac event (p=0.64), vascular access procedure for hemodialysis (p=0.19), and coronary or peripheral revascularization (p=0.88). Rosuvastatin achieved a 43% reduction in LDL cholesterol at 3 months, from a mean baseline level of 100 mg\/dL (2.6 mmol\/L), compared with a 1.9% reduction in the placebo group (p\u0026lt;0.001). Rosuvastatin reduced total cholesterol at 3 months by 26.6% from baseline, compared with a 0.5% reduction in the placebo group (p\u0026lt;0.001), and triglyceride levels were reduced by 16.2% from baseline in the rosuvastatin group, compared with an increase of 0.9% in the placebo group (p\u0026lt;0.001). Adverse event rates were similar between the 2 groups. In the rosuvastatin group, 1140 (82.1%) subjects suffered a serious adverse event versus 1159 (84.1%) in the placebo group (p=0.80; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Drug-related adverse events occurred in 16 (1.2%) subjects in the rosuvastatin group and 11 (0.8%) subjects in the placebo group (p=0.35; \u003Ca id=\u0022xref-table-wrap-1-2\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). The baseline characteristics between the 2 groups were balanced. Mean duration of treatment was 2.4 years, and mean duration of follow-up was 3.2 years.\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\/11501\/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\/11501\/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\/11501\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-5\u0022 class=\u0022first-child\u0022\u003EAdverse Events for Rosuvastatin 10 mg vs Placebo.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\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\/9\/2\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022AURORA Primary Study Endpoint of Major Cardiovascular Event.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-497099764\u0022 data-figure-caption=\u0022AURORA Primary Study Endpoint of Major Cardiovascular Event.\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\/9\/2\/14\/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\/9\/2\/14\/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\/9\/2\/14\/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\/11497\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 \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EAURORA Primary Study Endpoint of Major Cardiovascular Event.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ECopyright \u00a9 Massachusetts Medical Society 2009. All rights reserved.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EThe AURORA study was an international, multicenter, randomized, double-blind, prospective trial and was the largest and longest trial ever conducted on the efficacy of statins on cardiovascular events in persons with ESRD on hemodialysis. Patients with ESRD have advanced calcification of the arteries, and the lack of benefit on CV outcomes that was observed with statin therapy in 4D and AURORA suggests that cardiovascular disease in patients who receive chronic hemodialysis differs from that in other clinical settings. Inclusion criteria were men and women aged 50 to 80 years who had ESRD and were on hemodialysis for at least 3 months. Major exclusion criteria were taking a statin within the previous 6 months and needing a kidney transplant within the following year. The study design required 2750 subjects, and the study continued until 620 subjects had a major cardiovascular event. Assessment was every 3 months for the first year and every 6 months thereafter until the study\u0027s conclusion.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EDuring the question and answer session after the presentation, an audience member asked if the lack of efficacy resulted from the trial dose only being 10 mg. Dr. Fellstr\u00f6m replied, \u201cI wouldn\u0027t be surprised if it was a matter of dose.\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\/2\/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_figures.js?nzmkf1\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?nzmkf1\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?nzmkf1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}