THURSDAY, May 26 (HealthDay News) -- Although early research had suggested that the nutrient niacin might raise levels of "good" cholesterol and thwart heart attacks, a major clinical trial has been stopped 18 months early because it has shown no such benefit.
The trial, sponsored by the U.S. National Institutes of Health and a drug maker, enrolled patients with a history of heart disease who had their LDL ("bad") cholesterol under control with statin medications. The new trial hoped to use niacin (also known as vitamin B3) to boost levels of "good" HDL cholesterol while lowering blood levels of fats called triglycerides to help reduce the odds of heart attack or stroke.
Unfortunately, "this study has ended 18 months early because we have answered the primary question," Dr. Susan B. Shurin, acting director of the U.S. National Heart, Lung, and Blood Institute (NHLBI), said during a morning press conference Thursday. "While high-dose niacin raised participants' HDL cholesterol and lowered triglycerides, it did not affect the overall rate of cardiovascular events," she said.
"There was also an unexplained higher incidence of stroke in the high-dose niacin group, compared to the group on statins alone," Shurin added.
It is not clear if this trend toward stroke was merely a matter of chance, but it was a factor in the NHLBI's decision to stop the trial, especially in the face of a lack of benefit from niacin, she said.
"The U.S. Food and Drug Administration is aware of the findings and is recommending no change in labeling or practice [regarding niacin], pending full analysis of the data," Shurin said.
Prior to the trial, some observational studies had shown that low HDL cholesterol was a risk factor for heart attack and stroke, so it was thought that any drug that could boost HDL might help patients. In addition, some studies had shown that low HDL p
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