Harvard Heart Letter

Trial clouds use of niacin with a statin

Aiming high is usually a good strategy for achieving a goal... except when it backfires. That's what happened with a large clinical trial dubbed AIM-HIGH. It was suddenly stopped more than a year ahead of schedule, casting a cloud over the use of niacin, a safe, effective medication with a proven track record for raising levels of protective high-density lipoprotein (HDL).

AIM-HIGH was designed to gauge whether adding a prescription form of niacin (Niaspan) to a cholesterol-lowering statin makes sense for people with low HDL. This combination had been tested in earlier trials, all of which showed a benefit. The big difference in AIM-HIGH was the very low target for low-density lipoprotein (LDL, the so-called bad cholesterol): between 40 and 80 milligrams per deciliter (mg/dL).

The trial included 3,414 volunteers, all at high risk for a future heart attack or stroke — more than half had survived a heart attack, three-quarters had high blood pressure, and nearly all had coronary artery disease. All of the volunteers took simvastatin (Zocor) and, if needed, a second cholesterol-lowering medication called ezetimibe (Vytorin) to drive LDL below 80 mg/dL. Half took niacin, the other half a placebo.

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