AIM-HIGH Trial
|
High Density Lipoprotein Microchapters |
|
Diagnosis |
|---|
|
Treatment |
|
Clinical Trials |
|
Case Studies |
|
AIM-HIGH Trial On the Web |
|
American Roentgen Ray Society Images of AIM-HIGH Trial |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
AIM-HIGH Trial
Objective
To determine whether extended-release niacin and simvastatin combination to raise low levels of HDL cholesterol is superior to simvastatin alone in reducing residual cardiovascular risk.
Methods
AIM-HIGH is a randomized trial wherein 3414 patients randomly received either extended release niacin (1500 to 2000 md per day) or a matching placebo. All patients received simvastatin 40 to 80 mg daily to maintain an LDL-C level in the range of 40-80 mg/dL. Ezetimibe 10 mg daily was added, if needed, to achieve the LDL goal. The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
Results
The trial was stopped prematurely for futility after a follow-up of 36 months. At two years compared to placebo, niacin increased HDL-C levels and reduced triglyceride and LDL-C levels but there was no reduction in the rate of primary endpoint or all-cause mortality with niacin. Moreover, there was a trend towards more ischemic strokes in the niacin group. This led to the decision to halt the trial prematurely.
Conclusion
In patients with established atherosclerotic cardiovascular disease with LDL cholesterol below 70mg/dl, no incremental clinical benefit was observed from addition of niacin to simvastatin during a 36 month follow-up. Also, elevations in HDL-C levels in the placebo group were higher than expected which may have reduced the competency of the trial to detect a real benefit with niacin therapy.[1][2][3][4][5][6]
References
- ↑ Boden WE, Probstfield JL, Anderson T; et al. (2011). "Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy". N. Engl. J. Med. 365 (24): 2255–67. doi:10.1056/NEJMoa1107579. PMID 22085343. Unknown parameter
|month=ignored (help) - ↑ Michos ED, Sibley CT, Baer JT, Blaha MJ, Blumenthal RS (2012). "Niacin and statin combination therapy for atherosclerosis regression and prevention of cardiovascular disease events: reconciling the AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial with previous surrogate endpoint trials". J. Am. Coll. Cardiol. 59 (23): 2058–64. doi:10.1016/j.jacc.2012.01.045. PMID 22520249. Unknown parameter
|month=ignored (help) - ↑ Brinton EA (2012). "Search and rescue for hypotheses surviving AIM-HIGH, the niacin therapy earthquake: still problematic after the primary publication". J Clin Lipidol. 6 (4): 312–7. doi:10.1016/j.jacl.2012.03.005. PMID 22836067.
- ↑ Nicholls SJ (2012). "The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial: to believe or not to believe?". J. Am. Coll. Cardiol. 59 (23): 2065–7. doi:10.1016/j.jacc.2012.02.021. PMID 22520248. Unknown parameter
|month=ignored (help) - ↑ Nicholls SJ (2012). "Is niacin ineffective? Or did AIM-HIGH miss its target?". Cleve Clin J Med. 79 (1): 38–43. doi:10.3949/ccjm.79a.11166. PMID 22219232. Unknown parameter
|month=ignored (help) - ↑ Sharma M (2011). "Combination therapy for dyslipidemia". Curr. Opin. Cardiol. 26 (5): 420–3. doi:10.1097/HCO.0b013e3283499ef1. PMID 21832894. Unknown parameter
|month=ignored (help)