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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 the relationship between chronic kidney disease (CKD) and cardiovascular disease (CVD), and provided an overview of the SHARP trial, the largest study of lipid-lowering therapy in patients with CKD and CVD.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELipid Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELipid Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ERobert P. Giugliano, MD, SM, Brigham and Women\u0027s Hospital, Harvard Medical School, Boston, Massachusetts, USA, discussed the relationship between chronic kidney disease (CKD) and cardiovascular disease (CVD), and provided an overview of the SHARP trial, the largest study of lipid-lowering therapy in patients with CKD and CVD.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe National Kidney Foundation (NKF) defines CKD as kidney damage for \u22653 months with structural or functional abnormalities of the kidney, manifested either on pathology, or by clinical markers of kidney damage (eg, elevated creatinine). The patient may have a reduced glomerular filtration rate (GFR) \u0026lt;60 mL\/min\/1.73 m\u003Csup\u003E2\u003C\/sup\u003E for \u22653 months as well. In the United States, the vast majority of CKD patients are equally split between NKF Stages 1, 2, and 3 (GFR \u0026gt;90, 60 to 89, and 30 to 59 mL\/min\/1.73 m\u003Csup\u003E2\u003C\/sup\u003E, respectively), with only \u223c0.3% falling into Stages 4 and 5 (GFR of 15 to 29 and \u0026lt;15 mL\/min\/1.73 m\u003Csup\u003E2\u003C\/sup\u003E, respectively).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDiabetes and hypertension are the traceable causes of CKD in about two thirds of cases in the United States [\u003Ca href=\u0022http:\/\/www.kidney.org\/kidneydisease\/aboutckd.cfm\u0022\u003Ehttp:\/\/www.kidney.org\/kidneydisease\/aboutckd.cfm\u003C\/a\u003E. Accessed August 22, 2013]. Renal disease itself raises CV risk, and the severity of CKD is associated with the severity of CV risk.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAccording to data from the Kaiser Permanente Renal Registry of 1,120,295 adults, kidney function showed a linear increase in the adjusted risk of any CV event as the estimated GFR (eGFR) decreased [Go AS et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2004].\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe link between CKD and CV death is even stronger, with exponential increases in risk.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EA GFR of 60 is associated with a 2-fold risk of CV death, while a GFR of 30 carries a 4-fold increase in risk. There is a 10- to 30-fold increased risk in patients on dialysis.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EAGGRESSIVE LIPID LOWERING IN CKD\u003C\/h2\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EThe results of three different observational studies have suggested that patients with CKD should receive aggressive lipid-lowering therapy. The US Renal Data System Morbidity and Mortality Wave 2 study reported a 36% reduction in CV death (RR, 0.64; 95% CI, 0.45 to 0.91) in the 9.7% of patients on a statin [Seliger SL et al. \u003Cem\u003EKidney Int\u003C\/em\u003E 2002]. The prospective, observational Dialysis Outcomes and Practice Patterns Study from dialysis centers across seven countries showed a significant 23% reduction in cardiac mortality (p=0.03) in the 11.8% of patients taking a statin [Mason NA et al. \u003Cem\u003EAm J Kidney Dis\u003C\/em\u003E 2005]. Finally, the Pravastatin Pooling Project, a meta-analysis of clinical trials with pravastatin versus placebo, found a reduction in the composite of coronary heart disease death, myocardial infarction (MI), or revascularization (HR, 0.77; 95% CI, 0.68 to 0.86) and a decrease in total mortality (HR, 0.86; 95% CI, 0.74 to 1.00; p=0.045) in 4991 patients with Stage 3 CKD [Tonelli M et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2004]. Although the results from each study were hypothesis-generating, Dr. Giugliano maintained that they did not provide definitive evidence.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EHowever, two double-blind, placebo-controlled clinical trials of statin therapy in patients with CKD have been conducted. The 4D study of 1255 diabetic patients (aged 18 to 80 years) on dialysis \u0026lt;2 years showed a 42% reduction in low-denisity lipoprotein cholesterol (LDL-C) with atorvastatin 20 mg daily, but demonstrated no significant difference for the primary outcome of cardiac death, MI, or stroke at 4 years (RR, 0.92; 95% CI, 0.77 to 1.10; p=0.37) [Wanner C et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2005]. The AURORA study also showed a reduction in LDL-C, by 43% with rosuvastatin 10 mg, but there was no significant reduction in the primary endpoint of CV death, MI, or stroke at 4 years (HR, 0.96; 95% CI, 0.84 to 1.11; p=0.59) [Fellstr\u00f6m BC et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2009]. The AURORA study patients, with or without diabetes, were older on average (aged 50 to 80 years) and had been on dialysis \u0026gt;3 months. There were no significant differences for any of the individual endpoints in either study.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ETHE SHARP TRIAL OF LIPID-LOWERING IN CKD\u003C\/h2\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EThe Study of Heart and Renal Protection [SHARP] evaluated a broader population of CKD patients [SHARP Collaborative Group. \u003Cem\u003EAm Heart J\u003C\/em\u003E 2010]. Only about one third of patients were on dialysis. Eligible patients were aged \u226540 years, had CKD, had an elevated creatinine on at least two occasions (if not receiving dialysis; men \u22651.7 mg\/dL; women \u22651.5 mg\/dL), and had no history of MI or coronary revascularization. Equipoise was required, as LDL-lowering treatment was not indicated, nor was it contraindicated.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EPatients were randomized to a combination of ezetimibe 10 mg plus simvastatin 20 mg daily (eze\/simv; n=4193) or placebo (n=4191). For 1 year, 1054 patients received simvastatin 20 mg daily alone to assess safety, and were then randomized to eze\/simv. The final analysis included 4650 patients on eze\/simv and 4620 patients on placebo at a median follow-up of 4.9 years.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EThe study population was typical for moderate to severe renal disease. They had a mean age of 62 years, and were mildly hypertensive (139\/79 mm Hg) and overweight (body mass index 27 kg\/m\u003Csup\u003E2\u003C\/sup\u003E). Of the 6247 patients not on dialysis, the mean eGFR was 27 mL\/min\/1.73 m\u003Csup\u003E2\u003C\/sup\u003E and 80% had albuminuria. Women comprised 37% of the study population.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EThe primary outcome\u2014major atherosclerotic events (coronary death, MI, nonhemorrhagic stroke, or any revascularization)\u2014was significantly reduced with eze\/simv compared with placebo (HR, 0.83; log-rank 2-sided p=0.0022) [Baigent C et al. \u003Cem\u003ELancet\u003C\/em\u003E 2011]. The events accrued at a very stable pace of about 3% to 4% per year.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EAmong the treatment group, consistent effects were seen across all primary and subsidiary outcome measures, including major vascular events (overall reduction of 15.3%; p=0.0012; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Howevr, there was no effect on hemorrhagic stroke.\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\/13\/14\/12\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Results for the Primary Outcome and Major Vascular Events in SHARP\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1220449457\u0022 data-figure-caption=\u0022Results for the Primary Outcome and Major Vascular Events in SHARP\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\/13\/14\/12\/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\/13\/14\/12\/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\/13\/14\/12\/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\/13676\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-15\u0022 class=\u0022first-child\u0022\u003EResults for the Primary Outcome and Major Vascular Events in SHARP\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EEze\/simv=ezetimibe 10 mg plus simvastatin 20 mg daily.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced from Baigent C et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. \u003Cem\u003ELancet\u003C\/em\u003E 2011;377(9784):2181\u20132192. With permission from Elsevier.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EEze\/simv did not affect renal function, regardless of dialysis status, as measured by end-stage renal disease (ESRD), ESRD or death, or ESRD or a 2-fold increase in creatinine (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E). No statistical heterogeneity was found between dialysis and nondialysis patients (p=0.25).\u003C\/p\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\/13\/14\/12\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Renal Outcomes in the SHARP Study\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1220449457\u0022 data-figure-caption=\u0022Renal Outcomes in the SHARP Study\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\/13\/14\/12\/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\/13\/14\/12\/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\/13\/14\/12\/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\/13677\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 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-17\u0022 class=\u0022first-child\u0022\u003ERenal Outcomes in the SHARP Study\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EEze\/simv=ezetimibe 10 mg plus simvastatin 20 mg daily.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EReproduced from Baigent C et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. \u003Cem\u003ELancet\u003C\/em\u003E 2011;377(9784):2181\u20132192. With permission from Elsevier.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-18\u0022\u003EThere were no significant differences in safety outcomes between the two groups, and there were no signals of cancer (HR, 0.99; 95% CI, 0.87 to 1.13; log-rank 2-sided p=0.89).\u003C\/p\u003E\n         \u003Cp id=\u0022p-19\u0022\u003EAdherence to the eze\/simv regimen was maintained by about two thirds of patients. The study investigators calculated that full adherence with eze\/simv would reduce the risk of the primary outcome by 25%, avoiding 30 to 40 events for every 1000 patients treated over 5 years.\u003C\/p\u003E\n         \u003Cp id=\u0022p-20\u0022\u003EDr. Giugliano noted that the results of the IMPROVE-IT study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00202878\u0026amp;atom=%2Fspmdc%2F13%2F14%2F12.atom\u0022\u003ENCT00202878\u003C\/a\u003E], expected to be available in late 2014, should provide further evidence about the benefits of adding ezetimibe to a statin. The study is comparing eze\/simv 10\/40 mg and simvastatin 40 mg in patients with recent acute coronary syndrome.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 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\/13\/14\/12.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?nznnq1\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?nznnq1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}