THURSDAY, Nov. 11, 2004 (HealthDayNews) -- Researchers have found that a two-pronged approach to cholesterol management -- using one medication to boost the good cholesterol and another to lower the bad -- is more effective at slowing the progression of heart disease than one drug alone.
A new study says that adding extended-release niacin, a member of the vitamin B family, to cholesterol-lowering statins slowed the progression of atherosclerosis, or the dangerous buildup of plaque in the arteries. The findings may signal a shift in the focus of current treatment.
This study, the first to look at such a combination therapy, was reported Wednesday at the American Heart Association's scientific sessions in New Orleans and will appear in the association journal Circulation.
High cholesterol is a known risk factor for heart disease and stroke, among other ailments. Members of a class of drugs called statins have become the cornerstone of treatment for low-density lipoprotein (LDL, or the bad cholesterol); controlling LDL levels has become a main focus of much cardiology. LDL's nemesis, high-density lipoprotein (HDL, or the good cholesterol), works by helping to remove dangerous fats from the blood vessels.
"This is a combination which is very encouraging. . . We're beginning to gather evidence that making HDL levels higher will, in fact, either arrest development and maybe even reverse some of the atherosclerosis that's already there," said Dr. John C. LaRosa, president of the State University of New York Downstate Medical Center. "I don't think that means that you shouldn't lower LDL, but it does mean potentially that raising HDL will give you additional benefit. Most of the LDL-lowering trials still leave from two-thirds to one-half of patients going on to get another event, so it's not enough by itself."
Niacin is the most effective treatment to treat low HDL. However, no one has undertaken a study to look at the impact of adding niacin to statin treatment. One drawback of niacin is that it causes flushing, a sudden rush of redness in the face and upper body that some find difficult to tolerate.
This study, conducted by Walter Reed Medical Center researchers, involved 149 people with known coronary heart disease (some had suffered heart attacks) and low levels of HDL. All had been on a statin for about 4.5 years.
They were randomized to receive either Niaspan, an extended-release, prescription niacin, or a placebo. The study was partially funded by Kos Pharmaceuticals, which makes the product.
After one year, HDL increased 21 percent in the niacin group while the carotid intima-media thickness (CIMT) was unchanged. CIMT is a measurement of plaque buildup in the carotid artery, which feeds the brain. In the placebo group, on the other hand, CIMT increased significantly.
Overall, combining niacin with a statin slowed disease progression 68 percent more than a statin alone. The combination treatment also resulted in a 60 percent reduction in heart attacks, deaths, strokes, and other coronary events.
The researchers did not focus on changes in the number of "events," such as heart attacks; rather, the purpose was to find whether it had any effect on hardening of the carotid artery. "It's a surrogate endpoint, a pretty good one," LaRosa said. "The likelihood is that changes will be reflected in a lowering of events, but we don't have any direct evidence of that."
Niaspan causes less flushing than other forms of niacin. Taking the drug at bedtime with aspirin and a low-fat snack can reduce the flushing more. "It reduces side effects, but it doesn't not eliminate them," LaRosa said.
This type of focus on good cholesterol as opposed to bad cholesterol is likely to become more pronounced in the future. "We're going to see a lot of this kind of thing now," LaRosa predicted. "There are three or four studies yet out in the field to see how far we can take LDL and still see benefits. Once those are done, I think attention is going to shift to additional benefit from reducing inflammation, raising HDL, and starting medication earlier in life. We have to figure out how much more benefit we can wring out of this cholesterol beyond LDL lowering. This is one of the major items."
"This study gives us scientific evidence to document that if you add Niaspan to an aggressive, good LDL-lowering program, it actually did make a difference," said Dr. Stephen Siegel, a clinical assistant professor of medicine at New York University School of Medicine. "The trouble with the study is that it's such a small number of people."
A prescription form of niacin is an improvement, according to Siegel. Flushing has limited niacin's use in the past, but Niaspan "is a slow-release drug that you give at night, and most patients tolerate it well," he said.
The American Heart Association has more on the different types of cholesterol.