Published November 15, 2011
High-dose, extended-release niacin does not reduce the risk of heart attack, stroke and other cardiovascular events in patients with bad cholesterol (LDL) that is well controlled by statins.
Even after their bad cholesterol reaches ideal levels on statin therapy, many patients with stable heart and vascular disease risk heart attack, cardiac death and stroke because of low good cholesterol (HDL) and high triglycerides.
Boden and colleagues sought to find out if these patients would benefit from high doses of extended-release niacin. Of the AIM-HIGH clinical trial participants, 1,718 received 1,500 to 2,000 milligrams of niacin while 1,696 individuals received a placebo.
After two years, researchers found that, while the niacin raised patients’ good cholesterol by 25 percent and reduced triglyceride levels 29 percent, it did not reduce overall cardiovascular events.
For this reason, the National Heart, Lung and Blood Institute decided to stop the trial 18 months before its planned completion.
The AIM-HIGH trial was designed to study extended-release niacin, or Niaspan, in a narrowly defined patient population, Boden emphasizes.
He cautions that the study’s results cannot be extrapolated to the majority of patients, about 80 percent, who are unable to lower their LDL to the ideal levels seen in the study.
“In this modern era of statin therapy we’ve made profound progress in controlling LDL," he says. “However, based on the study’s results, physicians should not assume that boosting HDL levels with Niaspan is without merit.”
Jeffrey Probstfield, MD, professor of cardiology and medicine at the University of Washington, was co-principal investigator.