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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\u003EThe addition of aliskiren, a novel direct renin inhibitor that lowers plasma renin activity, to standard therapy (an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker) did not improve outcomes for people with type 2 diabetes and renal impairment who are at high risk for cardiovascular and renal events. This finding is among the preliminary results of Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints [ALTITUDE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00549757\u0026amp;atom=%2Fspmdc%2F12%2F13%2F13.1.atom\u0022\u003ENCT00549757\u003C\/a\u003E], which was stopped early in December 2011 because of futility and a high rate of adverse events in the aliskiren group.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHeart Failure\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EFeatured Meeting - Specialty page\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe addition of aliskiren, a novel direct renin inhibitor that lowers plasma renin activity, to standard therapy (an angiotensin-converting enzyme [ACE] inhibitor or an angiotensin receptor blocker [ARB]) did not improve outcomes for people with type 2 diabetes and renal impairment who are at high risk for cardiovascular (CV) and renal events. This finding is among the preliminary results of Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints [ALTITUDE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00549757\u0026amp;atom=%2Fspmdc%2F12%2F13%2F13.1.atom\u0022\u003ENCT00549757\u003C\/a\u003E], which was stopped early in December 2011 because of futility and a high rate of adverse events in the aliskiren group. Using aliskiren with an ACE inhibitor or ARB in this population is not recommended and may even be harmful, said Hans-Henrik Parving, MD, DMSc, University of Copenhagen, Copenhagen, and Aarhus University, Aarhus, Denmark, who presented the findings.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EALTITUDE included 8561 patients who were randomly assigned to treatment with standard therapy (an ACE inhibitor or ARB) plus aliskiren, 150 mg QD for 1 month, followed by 300 mg QD (4272 patients) or placebo (4285 patients). All patients had type 2 diabetes, renal dysfunction, and were at high risk for CV disease. The trial was designed to determine if the addition of aliskiren would provide better cardiorenal protection than monotherapy.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary endpoint was a composite of CV and renal outcomes, including CV death, resuscitated sudden death, non-fatal myocardial infarction, non-fatal stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease or renal death, or doubling of the baseline serum creatinine level (sustained for at least 1 month).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAt a median follow-up of 32 months, the rate of the composite endpoint was 17.9% in the aliskiren group and 16.8% in the placebo group (HR, 1.08; 95% CI, 0.98 to 1.20; p=0.14). Prof. Parving noted that when the individual components of the endpoint were analyzed separately, some occurred more frequently in the aliskiren group, but the differences were not significant (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\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\/14200\/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\/14200\/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\/14200\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\u003EALTITUDE HRs for Individual Components of the Primary Endpoint.\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\u003EHyperkalemia was the most common adverse event in the aliskiren group (38.7% vs 28.6%). Among the patients in that group, 8.8% had a serum potassium level \u22656 mmol\/L, compared with 5.6% in the placebo group. The serum potassium level was \u22655.5 to 6.0 mmol\/L in 21.0% of the aliskiren group and 16.0% of the placebo group. One death was associated with hyperkalemia. Other frequent adverse events in the aliskiren group included hypotension (12.1% vs 8.0%), diarrhea (9.6% vs 7.2%), and falls (2.8% vs 2.6%).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EIn discussing the study, Johannes Mann, MD, Friedrich Alexander University, Erlangen, Germany, and McMaster University, Hamilton, Ontario, Canada, noted that the reason for a possible increased risk of stroke was unclear. Dual inhibition of the renin system was not associated with such an increased risk in the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial [ONTARGET], in which the combination of ramipril (an ACE inhibitor) and telmisartan (an ARB) was compared with each drug used as monotherapy [Tobe SW et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2011]. Both Prof. Mann and Prof. Parving said that the observed risk could be a direct effect of aliskiren or could be a chance finding.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/12\/13\/13.1.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?nznb1f\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?nznb1f\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}