Trial DesignThe role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: Rationale and study design. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: Impact on Global Health outcomes (AIM-HIGH)
Section snippets
Background
Although atherosclerotic cardiovascular (CV) disease mortality has declined significantly over the past 4 decades, it remains the leading cause of death and disability among men and women in the Western world.1 Currently, over 13.2 million Americans have diagnosed coronary heart disease (CHD), and despite profound advances in both pharmacologic and interventional management over the past 15 years, both morbidity and mortality remain appreciable. Elevated low-density lipoprotein cholesterol
Participating clinical sites
Participating sites, identified based on successful recruitment in prior trials, were selected from outpatient internal medicine, cardiology, and diabetes clinics and catheterization and vascular laboratories. Study participants were recruited from 69 sites from the United States and 23 from Canada. Institutions included 33 private, 27 university, and 18 community hospitals; 12 Veterans Administration facilities; and 1 managed care clinic. Predominant recruitment strategies included
Results
AIM-HIGH completed enrollment in April 2010 (Fig. 1). Participants were recruited from the United States, 1,871 (55%) from non–Veterans Administration facilities and 475 (14%) from Veterans Administration facilities, and from Canada, 1,068 (31%). Of the 8,162 participants who signed informed consent, 2,825 were excluded because they did not meet the lipid criteria. The most common reason for exclusion of patients meeting lipid and CV disease entry requirements was unwillingness to discontinue
Discussion
Beginning with the Scandinavian Simvastatin Survival Study in 1994,14 clinical trials with statins have shown major coronary events to decrease in rough proportion to the on-treatment percent reduction in LDL-C and overall by about 30% of the placebo-treated rates.2 Thus, although statins, which principally lower LDL-C, reflect an important therapeutic advance, additional treatment measures are needed to further diminish the health impact of atherosclerotic vascular disease. AIM-HIGH is the
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Supported in part by National Institutes of Health, National Heart, Lung, and Blood Institute component grants U01 HL081616 and U01 HL081649, with additional unrestricted grant support and drug supply from Abbott Laboratories, Abbott Park, IL, and by drug supply from Merck, Inc., West Point, PA.
ClinicalTrials.gov identifier: NCT00120289.