AIM-HIGH fails to fly

Despite the efficacy of statins in reducing the risk of cardiovascular disease a substantial number of patients go on to have further events, even when LDL cholesterol targets are achieved.  Consequently, interest has grown in combination therapy approaches and the HDL raising treatment niacin – a drug now over 50 years old – has enjoyed something of a renaissance of late in this regard.

In the AIM-HIGH study 3414 patients with known atherosclerotic coronary disease who were already receiving simvastatin (40 to 80 mg) were randomized to 1500 to 2000 mg per day of extended-release niacin (n=1718) or placebo (n=1696). 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.  The trial was stopped early after a follow-up period of 3 years due to a lack of efficacy.  Despite niacin significantly increasing median HDL, lowering triglyceride levels and lowering LDL, the primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (HR, 1.02; 95% CI, 0.87 to 1.21; P=0.79). Although not reaching significance there was also a numerically higher rate of stroke in the niacin group (29 patients vs. 18 patients; HR, 1.61; 95% CI, 0.89 to 2.90; P=0.11).

Conclusions:

Extended release niacin, when added to modern secondary prevention therapies, failed to provide additional benefit to patients with known atherosclerotic cardiovascular disease.

  • The AIM-HIGH Investigators Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy. N Engl J Med. 2011 Nov 15. [Epub ahead of print]