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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\u003EEarly treatment with the angiotensin receptor blocker (ARB) olmesartan significantly reduced the risk of developing microalbuminuria among patients with type 2 diabetes, according to new interim findings from the ongoing Randomized Olmesartan and Diabetes Microalbuminuria Prevention [ROADMAP] trial. However, olmesartan also appeared to increase the risk of cardiovascular mortality, raising concerns about the safety of ARBs in this patient population.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Kidney Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EEarly treatment with the angiotensin receptor blocker (ARB) olmesartan significantly reduced the risk of developing microalbuminuria among patients with type 2 diabetes, according to new interim findings from the ongoing Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial. However, olmesartan also appeared to increase the risk of cardiovascular (CV) mortality, raising concerns about the safety of ARBs in this patient population.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe ROADMAP trial was designed to evaluate whether early intervention with an ARB prevented or delayed the onset of microalbuminuria (MAU), an early marker of renal disease and future CV events, in patients with type 2 diabetes. The multicenter randomized trial included 4449 men and women with type 2 diabetes, normal kidney function, and at least one additional CV risk factor, including hypertension. The mean baseline blood pressure (BP) level was 136\/81 mm Hg.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EParticipants were randomly assigned to treatment with olmesartan 40 mg daily (n=2232) or placebo (n=2215). Patients were permitted to receive other antihypertensive medications during the study, but not other angiotensin-converting enzyme (ACE) inhibitors or ARBs. The primary endpoint was time to onset of MAU, and secondary endpoints included renal and CV events. Hermann Haller, MD, Hannover Medical School, Hanover, Germany, presented 48-month findings from the ongoing ROADMAP trial.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ETreatment with olmesartan was associated with effective BP control. After 48 months, 78.2% and 71.3% of patients in the olmesartan and placebo groups, respectively, reached target BP levels of \u0026lt;130\/81 mm Hg.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EPatients in the olmesartan group were 23% less likely than those in the placebo group to develop microalbuminuria at 48 months (HR, 0.770; p=0.0104). The renoprotective benefit of olmesartan was independent of its effect on BP. MAU was less common in the olmesartan group after correcting for differences in diastolic BP (HR, 0.810; p=0.0398) and systolic BP (HR, 0.814; p=0.0451: \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E) between the ARB and placebo groups.\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\/10\/5\/9.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Time to First Occurrence of MAU.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1033037177\u0022 data-figure-caption=\u0022Time to First Occurrence of MAU.\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\/10\/5\/9.2\/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\/10\/5\/9.2\/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\/10\/5\/9.2\/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\/11329\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-7\u0022 class=\u0022first-child\u0022\u003ETime to First Occurrence of MAU.\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\u003EAccording to a safety analysis, olmesartan showed no detrimental effects on renal outcomes at 48 months. The composite risk of CV morbidity and mortality was 4.3% in the olmesartan group and 4.2% in the placebo group (HR, 1.00; p=0.99). Fatal CV events were rare, but occurred more frequently in the olmesartan group (n=15) than in the placebo group (n=3; HR, 4.94; p=0.01). The risk of CV mortality with olmesartan relative to placebo was significantly increased only among patients with preexisting CVD (p=0.02). CV deaths in the olmesartan group were also associated with hypotension, occurring more frequently in patients with the lowest systolic BP levels and in those who experienced the greatest reduction in systolic BP.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EOn June 11, 2010, the U.S. Food \u0026amp; Drug Association (FDA) announced that it is reviewing interim safety data from ROADMAP and the Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT), which also showed excess CV mortality with olmesartan compared with placebo. According to Prof. Haller, an observational follow-up study of ROADMAP is underway to further understand the long-term benefits of preventing the onset of MAU in patients with type 2 diabetes.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2010 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section ref-list\u0022 id=\u0022ref-list-1\u0022\u003E\u003Ch2 class=\u0022\u0022\u003EFurther Reading\u003C\/h2\u003E\u003Col class=\u0022cit-list ref-use-labels\u0022\u003E\u003Cli\u003E\u003Cspan class=\u0022ref-label ref-label-empty\u0022\u003E\u003C\/span\u003E\n            \u003Cdiv class=\u0022cit ref-cit ref-other no-rev-xref\u0022 id=\u0022cit-10.5.9-b.1\u0022\u003E\u003Cdiv class=\u0022cit-metadata\u0022\u003E\u003Ccite\u003E\u003Cspan class=\u0022cit-auth cit-collab\u0022\u003EFDA MedWatch\u003C\/span\u003E. \u003Cspan class=\u0022cit-article-title\u0022\u003EBenicar (olmesartan) Ongoing Safety Review\u003C\/span\u003E. \u003Ca href=\u0022http:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm215249.htm\u0022\u003Ehttp:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm215249.htm\u003C\/a\u003E.\u003C\/cite\u003E\u003C\/div\u003E\u003Cdiv class=\u0022cit-extra\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003C\/li\u003E\u003C\/ol\u003E\u003C\/div\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\/10\/5\/9.2.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?nzmqo2\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?nzmqo2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}