Please enable it to take advantage of the complete set of features! cIMT is only somewhat correlated with coronary atherosclerosis and may not fully mirror CHD events. The baseline mean LDL-C in AIM-HIGH was lower than in the HALTS and Oxford studies, which may partially explain the lack of benefit for additional niacin therapy. Thus, whether a strategy to increase HDL-C using adjunct pharmacotherapy to a background of statin treatment confers additional risk reduction remains unknown. "Effects of combination lipid therapy in type 2 diabetes mellitus" "Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease" Previously, small randomized, clinical trials of niacin plus statins showed that modest regression of carotid atherosclerosis is possible in individuals with CVD, CVD risk equivalents, or atherosclerosis. These studies mandate improved standardized methods to assess HDL-C function. Although cIMT has been deemed an acceptable surrogate endpoint for statin trials (20), a meta-analysis of 41 trials enrolling 18,307 participants suggested that regression or slowed progression of cIMT induced by cardiovascular drugs does not always reflect a decrease in cardiovascular events (21). . 3-Hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) are the standard of care for the management of dyslipidemia. This viewpoint summarizes some of the surrogate imaging trials using niacin-statin combination therapy and places them in the context of the AIM-HIGH findings. "If it ain't broke, don't fix it": a commentary on the positive-negative results of the ACCORD Lipid study. Other limitations to the use of surrogate markers include potential differential response to statins. "Does carotid intima-media thickness regression predict reduction of cardiovascular events? "Extended-release Niacin or Ezetimibe and carotid intima-media thickness" "Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy" The number of clinical endpoints in HATS and FATS was modest, although there was a reduction in the CVD primary endpoint in HATS with simvastatin-niacin versus placebo when antioxidants were not used. J Manag Care Pharm. . Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. COVID-19 is an emerging, rapidly evolving situation. Cannon C.P., Giugliano R.P., Blazing M.A. The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial, which compared combined niacin/simvastatin with simvastatin alone, failed to demonstrate an incremental benefit of niacin among patients with atherosclerotic CVD and on-treatment low-density lipoprotein cholesterol values <70 mg/dl, but this study had some limitations. J Am Coll Cardiol. Improving HDL-C function will be the focus of new therapies (2), particularly through enhancing reverse cholesterol transport but perhaps also through HDL-C's proposed antithrombotic, antioxidant, and anti-inflammatory properties. . Costanzo P., Perrone-Filardi P., Vassallo E. "Does carotid intima-media thickness regression predict reduction of cardiovascular events? Because niacin has LDL-C–lowering effects, this meant greater use of higher simvastatin doses in the placebo arm (25% of the placebo arm was taking simvastatin 80 mg vs. 18% of the niacin arm, p = 0.02) and also more ezetimibe in the placebo arm (22% vs. 10%, p < 0.001), which likely also confounded the results. 2010 Jun 15;9:24. doi: 10.1186/1475-2840-9-24. Observational studies have shown that low levels of high-density lipoprotein cholesterol (HDL-C) are associated with increased CVD risk. Hormone therapy and thiazolidinediones retard the progression of cIMT (17,18) but may be associated with adverse CVD events (19). "Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes" All rights reserved. In the JELIS (Japan EPA Lipid Intervention Study) study, there was an incremental benefit of adding eicosapentaenoic acid supplements to background statin therapy with a decrease in CVD events by 19% among patients with a history of CHD (23). Niacin-tolerant participants (N = 3,414) were then randomized to ERN (at 1,500 to 2,000 mg/day) or placebo (which contained a 50-mg dose of immediate-release niacin to help ensure blinding). "Meta-analysis of the effect of nicotinic acid alone or in combination on cardiovascular events and atherosclerosis" Targeting low HDL-cholesterol to decrease residual cardiovascular risk in the managed care setting. . The results of AIM-HIGH are disappointing. This viewpoint summarizes these imaging trials studying niacin and places them in the context of the failure of AIM-HIGH to support the HDL-C–increasing hypothesis. In an exploratory analysis, increasing niacin exposure resulted in a further reduction in cIMT, whereas increased cumulative ezetimibe exposure was associated with cIMT progression (13). Current Med Res Opin2006; 22: 2243. 10. . . Several small randomized controlled trials (RCTs) (ARBITER [Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol] [7,8], HALTS [9], Oxford Niaspan [10], and NIA [National Institute on Aging] Plaque [11]) tested the effect of adding niacin to statin therapy on the surrogate endpoint of carotid atherosclerosis among individuals with coronary heart disease (CHD) or risk equivalents (Table 1). This viewpoint summarizes these imaging trials studying niacin and places them in the context of the failure of AIM-HIGH to support the HDL-C-increasing hypothesis. Taylor A.J., Sullenberger L.E., Lee H.J., Lee J.K. and Grace K.A. 2016 Mar;11(1):97-107. doi: 10.1016/j.gheart.2015.12.014. Bruckert E., Labreuche J. and Amarenco P.: Only 22 niacin-treated and 29 placebo-treated participants completed the study (63% vs. 81% study completion, respectively). : 2008 Oct;14(8 Suppl):S3-28; quiz S30-1. Atherosclerosis2010; 210: 353. 9. 6. : N Engl J Med2007; 357: 1301. Circulation2009; 120: S376. The standard-treated group showed an increase in cIMT. Despite substantial risk reductions targeting low-density lipoprotein cholesterol with statins, there remains significant residual risk as evidenced by incident and recurrent cardiovascular disease (CVD) events among statin-treated patients. : : Observational studies have shown that low levels of high-d …. Clipboard, Search History, and several other advanced features are temporarily unavailable. Sharma K., Blaha M.J., Blumenthal R.S.