WASHINGTON - a drug that stimulates the good popular cholesterol not a go to prevent heart attack or stroke, leading authorities to abruptly stop an important study Thursday.
Disappointing results imply niacin super-strength, a type of vitamin b that many physicians prescribe already as a potential heart protection. Study failed mark the latest setback in the quest to exploit the good cholesterol against bad type.
"This sends a little to the drawing board", said Dr. Susan Shurin, cardiovascular Chief at the National Institutes of Health.
The wrong kind of cholesterol, called LDL, is the main source of artery clogs. Popular statin drugs, sold under such names as Zocor and Lipitor, generic shapes, are the pillars by lowering LDL. Yet many Statin users still have heart attacks, because LDL is not history.
Cholesterol HDL, the good kind, helps combat accumulation artery carrying fats in the liver to be disposed of. It is one of the reasons that people with too little HDL are also at risk of heart disease. If scientists are checking if giving HDL-stimulate statin drugs could provide cardiac patients added protection.
The latest study tested Abbott Laboratories' Niaspan, a form of niacin extended-release is a dose more than found in food supplements. The drug has been sold for years, and previous studies have shown that it increases levels of HDL. But nobody knew if that translates in heart attacks.
Researchers enrolled more than 3 400 Statin users to the United States and the Canada who had heart disease stable and controlled LDL, but was at risk due to low concentrations of HDL and too much a different bad fat triglyceride. They received Niaspan or a dummy pill to add to their daily medicine.
As expected, Niaspan users saw their rise of levels of HDL and their levels of drop of more than risky triglycerides people taking a statin alone. But the treatment of the combination does not reduce heart attacks, stroke, or the need for compensation artery as angioplasty procedures, said the NIH.
This conclusion "" unexpected and striking contrast with the results of previous tests, "said Dr. Jeffrey Probstfield, Washington University, who helped conduct the study."
But he led the NIH to stop the study 18 months in advance.
Adding the decision was a small increase of strokes in users high-dose niacin — 28 among those 1,718 given Niaspan, compared to 12 among the users of 1,696 placebo. The NIH said that it was not clear if this small difference was simply a coincidence. previous studies have shown no risk of stroke of niacin. In fact, some of the strokes occurred after Niaspan users stop taking this drug.
What is the message for cardiac patients?
Users Statin that have very low LDL levels, like those in this study have not need an additional prescription for niacin, said Dr. Robert Eckel, cardiologist of the University of Colorado and spokesperson for the American Heart Association who was not involved in the study.
But it is not clear if niacin would have no effect on people at high risk or those who do not yet have a diagnosis of heart disease, but take niacin as preventive, said study co-leader Dr. William Boden, of the University at Buffalo.
"We cannot generalize these findings... for patients that we investigate," he said.
Eckel said it is "really hard to envision exactly what will happen in offices of physicians" in coming weeks as they discuss the niacin with patients. The NIH has urged people not to stop high-dose niacin without consulting a physician.
Neither the conclusions stop hope that raise HDL finally will be panoramic, Eckel said. While two other drugs were not so, it closely monitors some much higher HDL-boosters, including a drug from Merck & Co., called anacetrapib, which are being developed.
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