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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\u003EApproximately two thirds of patients can tolerate extended-release niacin when combined with laropiprant, according to a prespecified interim safety and tolerability analysis of the Heart Protection Study 2: Treatment of HDL to Reduce the Incidence of Vascular Events [HPS2-THRIVE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00461630\u0026amp;atom=%2Fspmdc%2F12%2F13%2F27.atom\u0022\u003ENCT00461630\u003C\/a\u003E] study. The addition of niacin\/laropiprant to statin therapy offers a dual goal of decreasing low-density lipoprotein-cholesterol and increasing high-density lipoprotein-cholesterol.\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\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EApproximately two thirds of patients can tolerate extended-release (ER) niacin when combined with laropiprant, according to a prespecified interim safety and tolerability analysis of the Heart Protection Study 2: Treatment of HDL to Reduce the Incidence of Vascular Events [HPS2-THRIVE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00461630\u0026amp;atom=%2Fspmdc%2F12%2F13%2F27.atom\u0022\u003ENCT00461630\u003C\/a\u003E] study. The addition of niacin\/laropiprant to statin therapy offers a dual goal of decreasing low-density lipoprotein-cholesterol (LDL-C) and increasing high-density lipoprotein-cholesterol (HDL-C).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ENiacin, the first lipid-modifying drug, is one of the most effective agents for increasing HDL-C levels. However, its use has been limited by its side effects, particularly flushing. Coadministration of laropiprant, a selective prostaglandin D antagonist, has been shown to reduce flushing. However, the drug may not reduce this side effect in all patients, as flushing can occur through other pathways.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EHPS2-THRIVE includes more than 25,000 patients in Europe and China who have cardiovascular disease (CVD) and are at high risk for recurrent vascular events. The patients were randomly assigned to ER niacin 2 g\/laropiprant or to placebo. All patients also received LDL-C reducing therapy with simvastatin 40 mg, with or without ezetimibe 10 mg. The study is the largest one to date to evaluate the CV benefits of increasing HDL-C levels. Jane Armitage, MD, Oxford Clinical Trial Service, Oxford, United Kingdom, reported on the safety and tolerability of the combination drug.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPatients were treated with ER niacin\/laropiprant or placebo during an 8-week run-in phase prior to randomization. During this phase, 25.4% of patients in the ER niacin\/laropiprant group withdrew from therapy for any medical reason; the primary reasons were cutaneous effects (primarily flushing, 11.3%) and gastrointestinal symptoms (5.5%). An additional 8.7% of patients in this group withdrew during the randomized treatment phase, again primarily because of cutaneous effects (5.1%) and gastrointestinal symptoms (3.6%). Among patients in the placebo group, 1.2% withdrew during the treatment phase because of cutaneous effects and 1.6% because of gastrointestinal symptoms.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EProf. Armitage noted that ER niacin\/laropiprant was associated with a high rate of myopathy (1.13% vs 0.18% in the placebo group). This finding was seen primarily in patients of Chinese descent (62 of 69 patients with myopathy were from China). Overall, rhabdomyolysis was rare (0.05% in the treatment group and 0.02% in the placebo group). The identification of an increased risk of myopathy with niacin and simvastatin prompted the following change to the simvastatin label: \u201cPatients of Chinese descent should not receive simvastatin 80 mg with cholesterol-modifying doses of niacin-containing products.\u201d\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EProf. Armitage reported that during the run-in phase, LDL-C levels were reduced by 20% and HDL-C levels were increased by 17%. These results differ from those in the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL\/High Triglycerides: Impact on Global Health Outcomes [AIM-HIGH] trial, in which LDL-C levels were reduced 5.5% and HDL-C levels were increased by 13.2% [AIM-HIGH Investigators. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2011]. The AIM-HIGH trial was stopped early because of a lack of benefit of niacin. Whether the more favorable effects on LDL-C lowering and HDL-C raising in HPS2-THRIVE and better tolerability of niacin when combined with laropiprant will translate into a reduction in vascular events will have to wait until the presentation of the study\u0027s primary efficacy results in 2013.\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\/27.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?nznbi2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}