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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 evidence from clinical trials addressing the reduction of cardiovascular (CV) risk with antihyperglycemic drugs. Specific trials include the UKPDS, ACCORD, RECORD, NAVIGATOR, and ORIGIN trials, as well as a number of ongoing clinical trials examining the CV safety of dipeptidyl peptidase-4 inhibitors.\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\u003EHypertensive Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe evidence from clinical trials addressing the reduction of cardiovascular (CV) risk with antihyperglycemic drugs was discussed by Peter M. Nilsson, MD, PhD, Lund University, Malm\u00f6, Sweden.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EMetformin became first-line therapy for type 2 diabetes mellitus (T2DM) after the findings of UKPDS34, which showed a 39% relative reduction in myocardial infarction (MI) in overweight T2DM patients (n=342) treated with the drug versus those treated with conventional treatment (RR, 0.61; 95% CI, 0.41 to 0.89; p=0.01) [UK Prospective Diabetes Study Group. \u003Cem\u003ELancet\u003C\/em\u003E 1998]. A meta-analysis of 12 randomized trials, including data on metformin, showed that it was beneficial for CV events versus placebo or no treatment in patients with T2DM (OR, 0.79; 95% CI, 0.64 to 0.98; p=0.031) but similar to active comparators [Lamanna C et al. \u003Cem\u003EDiabetes Obes Metab\u003C\/em\u003E 2011]. An overall comparison of metformin versus placebo, no treatment, or active comparator also found no significant difference between the groups. Yet, according to Prof. Nilsson, metformin should remain a first-line drug.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the ACCORD trial, intensive therapy was associated with a positive but nonsignificant benefit on the primary composite outcome of nonfatal MI, nonfatal stroke, or CV death in T2DM patients with CV disease (CVD) or CV risk factors when compared with standard therapy (HR, 0.90; 95% CI, 0.78 to 1.04; p=0.16) [ACCORD Study Group. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2008]. An increased risk in all-cause mortality was found with intensive therapy versus standard therapy (HR, 1.22; 95% CI, 1.01 to 1.46; p=0.04). This surprising finding spurred several meta-analyses to evaluate the potential effects of antihypertensive drugs on CV endpoints in T2DM, said Prof. Nilsson.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EA meta-analysis of 5 studies, including UKPDS and ACCORD, showed a 17% reduction in the risk of nonfatal MI (OR, 0.83; 95% CI, 0.75 to 0.93) and a 15% reduction in the risk of coronary heart disease (OR, 0.85; 95% CI, 0.77 to 0.93) with intensive glucose lowering versus standard treatment with an antihypertensive agent [Ray KK et al. \u003Cem\u003ELancet\u003C\/em\u003E 2009]. The 33,040 T2DM patients in this meta-analysis were followed for a mean of 4.95 years. There were no significant differences between the two groups in the risk of stroke (OR, 0.93; 95% CI, 0.81 to 1.06) or all-cause mortality (OR, 1.02; 95% CI, 0.87 to 1.19).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe RECORD trial showed no difference in the outcome of CV hospitalization or CV death with rosiglitazone during a mean follow-up of 5.5 years compared with a combination of metformin and sulfonylurea in T2DM patients who were already on metformin or sulfonylurea monotherapy (HR, 0.99; 95% CI, 0.85 to 1.16; p=0.93) [Home PD et al. \u003Cem\u003ELancet\u003C\/em\u003E 2009]. The annual event rate was about 2.8% for each drug. Rosiglitazone was removed from the market because of these results. In June 2013, based on the required readjudication of CV events in RECORD, the FDA panel eased the restrictions on its use [American Heart Association. Press Release. \u003Ca href=\u0022http:\/\/newsroom.heart.org\/news\/fda-panel-recommends-easing-avandia-restrictions\u0022\u003Ehttp:\/\/newsroom.heart.org\/news\/fda-panel-recommends-easing-avandia-restrictions\u003C\/a\u003E. Published June 06, 2013].\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ENateglinide, a new insulin secretor drug, did not reduce CV outcomes compared with placebo in the NAVIGATOR study [NAVIGATOR Study Group. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010]. In patients with T2DM or impaired fasting glucose, and CVD or CV risk factors, the occurrence of the outcomes was similar in both nateglinide and placebo groups for the extended CV endpoint (15.2% vs 14.2%; HR, 0.93; 95% CI, 0.83 to 1.03; p=0.16) as well as the core CV endpoint (7.9% vs 8.3%; HR, 0.94; 95% CI, 0.82 to 1.09; p=0.43) over a median follow-up of 6.3 and 6.4 years, respectively. Prof. Nilsson stated that it is a challenge to obtain benefit with add-on therapy with new drugs because T2DM patients are well managed with current treatments.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EIn the ORIGIN trial, 12,537 patients aged \u226550 years with dysglycemia and high CV risk were randomized to insulin glargine or standard care and followed up to a median of 6.2 years [ORIGIN Trial Investigators. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012]. Both coprimary endpoints were neutral. The first coprimary outcome was CV death, nonfatal MI, or nonfatal stroke (adjusted HR, 1.02; 95% CI, 0.94 to 1.11; p=0.63). The second coprimary endpoint was CV death, nonfatal MI, nonfatal stroke, revascularization, or hospitalization for heart failure (adjusted HR, 1.04; 95% CI, 0.97 to 1.11; p=0.27). The reduction in median HbA1c favored glargine (6.2%) over standard treatment (6.5%) at 7 years.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EA post hoc analysis of ORIGIN [ORIGIN-GRACE] showed slower progression of carotid intima-media thickness as measured by ultrasound with insulin glargine compared with standard treatment (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E) [Lonn EM et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2013]. Although this has a positive effect on target organ damage, it is not known whether this finding would translate to a reduction in CV events, said Prof. Nilsson.\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\/13\/9\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Progression of Carotid Intima Media Thickness\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-539200247\u0022 data-figure-caption=\u0022Progression of Carotid Intima Media Thickness\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\/9\/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\/13\/9\/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\/13\/9\/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\/13429\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-10\u0022 class=\u0022first-child\u0022\u003EProgression of Carotid Intima Media Thickness\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EBIF=bifurcation; CC=common carotid; CIMT=carotid intima-media thickness.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced from Lonn EM et al. Effect of Insulin Glargine and n-3FA on Carotid Intima-Media Thickness in People With Dysglycemia at High Risk for Cardiovascular Events: The Glucose Reduction and Atherosclerosis Continuing Evaluation Study (ORIGIN-GRACE). \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2013. With permission from the American Diabetes Association.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EThe current treatment algorithm for T2DM from the American Diabetes Association and the European Association for the Study of Diabetes is shown in \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E [Inzucchi SE et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2012].\u003C\/p\u003E\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\/9\/14\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The ADA\/EASD Treatment Algorithm for T2DM\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-539200247\u0022 data-figure-caption=\u0022The ADA\/EASD Treatment Algorithm for T2DM\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\/9\/14\/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\/9\/14\/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\/9\/14\/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\/13431\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-12\u0022 class=\u0022first-child\u0022\u003EThe ADA\/EASD Treatment Algorithm for T2DM\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EADA=American Diabetes Association; EASD=European Association for the Study of Diabetes.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EReproduced from Inzucchi SE et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2012; 35:1364\u20131379. With permission from the American Diabetes Association.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-13\u0022\u003ERegarding second-line drug choices, there are no trial data to show that one drug class is superior to another, said Prof. Nilsson. He noted that some of the antihyperglycemic agents that have a positive effect on lipids are insulin, metformin, glitazones for dyslipidemia, and incretins.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EThere are a number of ongoing clinical trials examining the CV safety of dipeptidyl peptidase-4 inhibitors (linagliptin [CAROLINA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01243424\u0026amp;atom=%2Fspmdc%2F13%2F9%2F14.atom\u0022\u003ENCT01243424\u003C\/a\u003E], sitagliptin [TECOS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00790205\u0026amp;atom=%2Fspmdc%2F13%2F9%2F14.atom\u0022\u003ENCT00790205\u003C\/a\u003E], saxagliptin [SAVOR-TIMI-53; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01107886\u0026amp;atom=%2Fspmdc%2F13%2F9%2F14.atom\u0022\u003ENCT01107886\u003C\/a\u003E], and alogliptin [EXAMINE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00968708\u0026amp;atom=%2Fspmdc%2F13%2F9%2F14.atom\u0022\u003ENCT00968708\u003C\/a\u003E]), and some with insulin endocrine analogues. In particular, the results of the randomized, double-blind, SAVOR-TIMI-53 study with saxagliptin in \u0026gt;16,000 T2DM patients are anticipated soon [Scirica BM et al. \u003Cem\u003EAm Heart Journal\u003C\/em\u003E 2011]. This is the first real test of the new principal of influencing the endocrine system, said Prof. Nilsson.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EThe new and more effective antihyperglycemic drugs exploring new mechanisms could have the potential to be more effective for CV prevention.\u003C\/p\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\/9\/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?nznuy2\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?nznuy2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}