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Updated 10:00 AM October 23, 2006
 

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  Research
Authors say potential heart patients should take statins

Americans have been trying to get their cholesterol levels down for decades, ever since studies showed a strong link between high cholesterol and heart disease.

But in recent years, experts have suggested some people should aim even lower. They recommend very low levels of the type of cholesterol called low-density lipoprotein (LDL) for some high-risk people—even if it means they have to take multiple medications.

Not so fast, says a team of researchers from the VA Ann Arbor Healthcare System and the U-M Health System in a new paper in the October Annals of Internal Medicine.

After an exhaustive review of existing research on LDL cholesterol and heart health, team members conclude that there is no scientifically valid evidence to support the ultra-low LDL target of 70 milligrams/deciliter for very high-risk patients that has been advocated by some members of the federal government's National Cholesterol Education Program (NCEP). Further, they suggest that the evidence previously cited to support an LDL goal of less than 100 milligrams/deciliter for high-risk patients also has major flaws.

That evidence may come someday, but until then, it may be better for society to concentrate less on cholesterol and more on getting people with multiple heart disease risk factors on medications called statins—regardless of their cholesterol levels. Statins lower a person's LDL cholesterol, but it is not yet clear if lowering cholesterol is the main reason that statins prevent heart attacks and save lives. A focus on statin therapy may provide more public benefit than focusing on getting high-risk patients' levels as low as they can go using multiple drugs.

"Our review suggests that we in the medical community have misunderstood the scientific evidence on whether very low LDL is important, or whether adequate doses of statins are what is really important," says lead author Dr. Rodney Hayward, director of the VA Center for Health Services Research and Development and professor of internal medicine at the Medical School. "Current practice guidelines and recommendations often focus on getting LDL as low as possible, but the literature to date doesn't demonstrate that low LDL is what is truly important—but it does show that statins save lives in high cardiac risk patients regardless of a person's LDL level."

In fact, Hayward and his colleagues say, it may be that the other effects of statin drugs help reduce the risk of heart disease and heart attacks as much or more than the drugs' LDL-lowering power does. Statins inhibit inflammation and clotting, as well as reduce cholesterol, attributes that can be important for preventing heart attacks.

People who have survived a heart attack or have risk factors that put them at high risk of future heart problems probably should be on a moderate or high dose of a statin and stay on it no matter what happens to their exact LDL level, Hayward says.

The benefits and safety of using multiple medications to get LDL levels low is open to debate, however, and is not supported by valid clinical evidence, he adds. Still, many physicians recommend using statins in combination with medications such as niacin, gemfibrozil, fenofibrate and newer drugs to try to bring LDL levels down to low levels.

"Going beyond statin therapy is becoming more common, but when you do that, you are also going beyond the current evidence," Hayward says. "Neither the benefit nor the long-term safety of using multiple medicines to lower LDL cholesterol has been studied to date. There is a temptation to believe that lower cholesterol is always good, but recently two treatments that improve cholesterol profiles, hormone replacement therapy and muraglitazar, were found to actually harm people. We would never have known this if we hadn't insisted on scientifically rigorous assessments of these treatments."

Until more evidence is available, the authors emphasize the importance of getting more people to modify their diet, exercise more, understand their overall risk of heart disease and take a statin if their risk is high.

"Statins are lifesaving medicines when used in high-risk patients," says Hayward. "They can reduce the risk of heart attacks and strokes by 30 percent to 35 percent and the risk of dying by 20 percent to 25 percent, and we need to work harder to help people at risk take them and afford them.

"We do not have many instances where medicines can save lives and money, but this may be one of those instances."

Individuals who know their cholesterol levels can assess their heart risk using the NCEP online calculator: hp2010.nhlbihin.net/atpiii/calculator.asp.

The study was funded by the VA HSR&D Service and by the National Institutes of Health. In addition to Hayward, its authors are Drs. Sandeep Vijan and Timothy Hofer, both of the VA Ann Arbor and the U-M Division of General Medicine.

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