Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy - PubMed (original) (raw)
Randomized Controlled Trial
. 2011 Dec 15;365(24):2255-67.
doi: 10.1056/NEJMoa1107579. Epub 2011 Nov 15.
Collaborators
- PMID: 22085343
- DOI: 10.1056/NEJMoa1107579
Free article
Randomized Controlled Trial
Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy
AIM-HIGH Investigators et al. N Engl J Med. 2011.
Free article
Erratum in
- N Engl J Med. 2012 Jul 12;367(2):189
Abstract
Background: In patients with established cardiovascular disease, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein (LDL) cholesterol levels with statin therapy. It is unclear whether extended-release niacin added to simvastatin to raise low levels of high-density lipoprotein (HDL) cholesterol is superior to simvastatin alone in reducing such residual risk.
Methods: We randomly assigned eligible patients to receive extended-release niacin, 1500 to 2000 mg per day, or matching placebo. All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to 2.07 mmol per liter). 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: A total of 3414 patients were randomly assigned to receive niacin (1718) or placebo (1696). The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter), lowered the triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter), and lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter). The primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (hazard ratio, 1.02; 95% confidence interval, 0.87 to 1.21; P=0.79 by the log-rank test).
Conclusions: Among patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter (1.81 mmol per liter), there was no incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period, despite significant improvements in HDL cholesterol and triglyceride levels. (Funded by the National Heart, Lung, and Blood Institute and Abbott Laboratories; AIM-HIGH ClinicalTrials.gov number, NCT00120289.).
Comment in
- Venous thromboembolism: Increased embolic risk from combined oral contraceptives.
Lim GB. Lim GB. Nat Rev Cardiol. 2011 Nov 15;9(1):3. doi: 10.1038/nrcardio.2011.171. Nat Rev Cardiol. 2011. PMID: 22083021 No abstract available. - Niacin at 56 years of age--time for an early retirement?
Giugliano RP. Giugliano RP. N Engl J Med. 2011 Dec 15;365(24):2318-20. doi: 10.1056/NEJMe1112346. Epub 2011 Nov 15. N Engl J Med. 2011. PMID: 22085318 No abstract available. - Vascular disease: No added benefit of niacin with statins.
Lim GB. Lim GB. Nat Rev Cardiol. 2011 Nov 29;9(1):3. doi: 10.1038/nrcardio.2011.184. Nat Rev Cardiol. 2011. PMID: 22124312 No abstract available. - Clinical trials of HDL cholesterol-raising therapy: what have we learned about the HDL hypothesis from AIM-HIGH?
Rosenson RS. Rosenson RS. Curr Atheroscler Rep. 2012 Jun;14(3):190-2. doi: 10.1007/s11883-012-0236-1. Curr Atheroscler Rep. 2012. PMID: 22396197 No abstract available. - Niacin in cardiovascular patients receiving statins.
Brouwers MC, Stehouwer CD. Brouwers MC, et al. N Engl J Med. 2012 Mar 29;366(13):1255; author reply 1255-6. doi: 10.1056/NEJMc1200980. N Engl J Med. 2012. PMID: 22455426 No abstract available. - [Added niacin administration to statins in low HDL has no additive effect in nonacute cardiovascular diseases].
Woitzek K. Woitzek K. Praxis (Bern 1994). 2012 Apr 11;101(8):551-2. doi: 10.1024/1661-8157/a000895. Praxis (Bern 1994). 2012. PMID: 22492078 German. No abstract available. - ACP Journal Club. Adding niacin to simvastatin did not improve clinical outcomes in patients with CV disease and dyslipidemia.
Smith DA. Smith DA. Ann Intern Med. 2012 Apr 17;156(8):JC4-08. doi: 10.7326/0003-4819-156-8-201204170-02008. Ann Intern Med. 2012. PMID: 22508748 No abstract available. - Niacin's effect on cardiovascular risk: have we finally learned our lesson?
Nicholls SJ. Nicholls SJ. Cleve Clin J Med. 2014 May;81(5):275-7. doi: 10.3949/ccjm.81a.13067. Cleve Clin J Med. 2014. PMID: 24789584 No abstract available.
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