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Niacin Is Ineffective in Patients with Established Cardiovascular Disease

Niacin plus simvastatin was no better than simvastatin alone.

Physicians sometimes prescribe niacin for statin-treated patients to raise HDL cholesterol levels or to manipulate lipid subfractions detected by more elaborate lipid testing. However, the clinical effect of this practice is unclear. In the NIH-sponsored AIM-HIGH study, 3414 patients with established cardiovascular disease were randomized to receive simvastatin plus either extended-release niacin or placebo. Enrollment criteria included HDL cholesterol levels <40 mg/dL for men and <50 mg/dL for women, and triglyceride levels between 150 and 400 mg/dL. Patients were selected for randomization only after completing an open-label run-in phase, during which they demonstrated that they could tolerate high niacin doses (1500–2000 mg daily). During the trial, most patients took 40-mg or 80-mg simvastatin daily; the LDL cholesterol target was <80 mg/dL. Most patients also received aspirin, β-blockers, and angiotensin-converting–enzyme inhibitors.

Compared with placebo, niacin therapy induced significant changes in LDL cholesterol, HDL cholesterol, and triglyceride levels. Nevertheless, the trial was stopped after average follow-up of 3 years when no hint of cardiovascular benefits and a trend toward more strokes with niacin were reported. The primary outcome (a composite of adverse coronary events, strokes, and revascularization) occurred in 16% of patients in each group; the incidence of stroke was 1.7% with niacin and 1.1% with placebo (P=0.09).

Comment: These results — first announced in May 2011 (JW Gen Med Jun 7 2011) — are straightforward: Extended-release niacin doesn't benefit patients with known cardiovascular disease who achieve low LDL cholesterol levels with statin monotherapy (the average LDL cholesterol level in this study's statin-plus-placebo group was about 70 mg/dL). Note that this study was purely a secondary prevention trial; we also have no evidence that niacin improves outcomes in contemporary primary prevention.

— Allan S. Brett, MD

Published in Journal Watch General Medicine November 15, 2011

Citation(s):

The AIM-HIGH Investigators. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med 2011 Nov 15; [e-pub ahead of print]. (http://www.nejm.org/doi/full/10.1056/NEJMoa1107579)

Reader Remarks:

Review and add to remarks on this article

• niacin and LDL reduction
  Carol A Rosenberg, 15 Nov 2011 11:15 AM EST
  Specialty: Internal Medicine
  Is there information from the study regarding the adjuvant role of niacin in lowering LDL cholesterol when statins alone fail... [more]
• Niacin in Cardiovascular disease.
  Clint M. Blumer, Retired, 17 Nov 2011 9:51 AM EST
  Specialty: Anesthesiology
  Are Statins effective with Cardiovascular disease?
• Diabetes Mellitus
  Reginald Nnamdi OPUTA, 23 Nov 2011 9:04 AM EST
  Specialty: Endocrinology Diabetes Metab
  Has received UN attention, A global issue and epdermi c. Africa needs special atte ntion in view of poor health... [more]
• AimHigh results
  Charles S, 28 Nov 2011 1:35 PM EST
  Specialty: Family Medicine
  The results are not surprising in that most of the benefit of Niaspan therapy comes from LDL-P reduction, not from... [more]
• niacin does no good?
  Hu Hao, 28 Nov 2011 1:35 PM EST
  Specialty: Cardiovascular Disease
  Though niacin did not add additional benefits to patients,it remains unclear why niacin in addition increased the risk of stroke.Moreover,this... [more]
• Niacin@ low LDL's
  H Robert Silverstein, MD,FACC, Preventive Medicine. Center, 14 Feb 2012 11:48 AM EST
  Specialty: Cardiovascular Disease
  I only mean this with a certain lightness of humor. Alan Brett should be ashamed of himself for using such... [more]
• Response from JW General Medicine Editor-in-Chief
  Allan Brett, MD, 14 Feb 2012 12:45 PM EST
  Specialty: Internal Medicine
  Dr. Silverstein: Your point is well taken. We'll try to be more careful in the future. Constructing titles can be... [more]

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