Breaking Health News, March 10, 2004

Cholesterol Study Finds Reasons For Intensive Therapy

"Profound" Implications To Challenge Current Cholesterol Recommendations

< March 10, 2004 > -- Aggressive treatment with cholesterol-lowering medications can dramatically lower heart disease risk and save lives, according to a major study presented at the American College of Cardiology meeting in New Orleans and published in the New England Journal of Medicine (NEJM).

New research shows high levels of medications called statins, given to people who have just been hospitalized with heart attacks or high-risk unstable angina, not only saved lives but also helped prevent future problems.

Currently, statins are considered a major componet of the standard of care for heart disease prevention and treatment of heart attack.

Researchers Find Conclusive Evidence

The new research findings suggest that higher doses of statins than are currently prescribed will lead to a better outcome for patients.

"The implications of this turning point - that is, of the new era of intensive statin therapy - are profound," says Dr. Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation and author of an editorial in the NEJM.

Current guidelines from the National Cholesterol Education Program state that levels of LDL cholesterol, the kind referred to as the "bad" cholesterol, should reach 100 milligrams/per deciliter (mg/dL) or below. But the new study has definitively found that lowering this number considerably, by more than one-third below 100 mg/dL was very beneficial.

"This will have a major impact in the real world," says Dr. Topol. "It was striking how fast it was. It was a whopping benefit and unexpected. This changes everything."

Dr. Christopher P. Cannon, co-author of the study and a cardiologist at Brigham and Women's Hospital in Boston, says, "The basis of our study was that statins were tested and were very, very effective. But the drugs had not yet been tested in a hospital setting in people who were seriously ill."

The current study set out to answer two questions, Dr. Cannon says.

The first was whether statins would be effective in heart attack patients in a hospital setting. The second, and bigger question, was whether it would be worth it to lower cholesterol levels by 50 percent, instead of the 25 percent already demonstrated.

The trial involved 4,162 patients at 349 sites in eight countries. All of the participants had been hospitalized within the past 10 days with either a heart attack or high-risk, unstable angina.

The study compared 40 mg daily of pravastatin (Pravachol^TM) to 80 mg daily of atorvastatin (Lipitor^TM). These doses were the highest approved doses at the time of the study.

Patients who were given Lipitor reduced their LDL to an average of 62 mg/dL compared to those given Pravachol with an average of 95 mg/dL.

Over a period of about 24 months, the Lipitor group showed a 16 percent lower risk of overall major cardiovascular events and a 28 percent reduction in death.

Every outcome measured was better in the Lipitor group, except for stroke, which was about the same in both groups.

The downside of this more intensive treatment is minimal, Dr. Cannon adds.

"We have to be a little cautious on the liver," he says. About 1 percent of the control group and 3 percent of the intensive therapy group experienced liver problems.

More People Need This Therapy, Experts Say

Dr. Cannon says, "Hopefully the very clear results will mean that people going home from the hospital will get this treatment."

Currently, says Dr. Topol, "Only a fraction of the patients who should be treated with a statin are actually receiving such therapy." He reports that about 11 million US adults are getting statins when an estimated 36 million should be on them.

This is largely a cost issue, Dr. Topol states. At a collective $12.5 billion, statins are the largest prescription drug expenditure in the US, he writes.

"Treatment based on the new data could cause the costs associated with statin therapy to skyrocket even further," Dr. Topol says.

Always consult your physician for more information.

Online Resources

(These links are provided for the education and convenience of our Neighbors. AAMC is not responsible for the content of Internet sites.)

American Heart Association

Centers for Disease Control and Prevention (CDC)

HealthierUS.Gov

National Cholesterol Education Program

National Heart, Lung, and Blood Institute

National Institutes of Health (NIH)

National Library of Medicine

US Food and Drug Administration

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Cholesterol Facts

Cholesterol is a waxy substance that can be found in all parts of your body. It aids in the production of cell membranes, some hormones, and vitamin D.

The cholesterol in your blood comes from two sources: the foods you eat and your liver. However, your liver makes all of the cholesterol your body needs.

Elevated cholesterol is a risk for many Americans. About 105 million US adults have total blood cholesterol levels of 200mg/dL and higher, and of those about 42 million American adults have level of 240 or above.

Elevated cholesterol levels early in life may play a role in the development of adult atherosclerosis.

According to the American Heart Association, high blood cholesterol that runs in families will affect the future of an unknown (but probably large) number of children.

Cholesterol and other fats are transported in your blood stream in the form of spherical particles called lipoproteins. The two most commonly known lipoproteins are low-density lipoproteins (LDL) and high-density lipoproteins (HDL).

LDL: This type of cholesterol is commonly called the "bad" cholesterol, and is a type of fat in the blood that contains the most cholesterol. It can contribute to the formation of plaque buildup in the arteries, known as atherosclerosis.

You want your LDL to be low. To help lower it:

• avoid foods high in saturated fat, dietary cholesterol, and excess calories
• exercise
• maintain a healthy weight
• stop smoking

HDL: This type of cholesterol is known as the "good" cholesterol, and is a type of fat in the blood that helps to remove cholesterol from the blood, preventing the fatty buildup and formation of plaque.

You want your HDL to be as high as possible. Some people can raise HDL by:

• exercising for at least 20 minutes three times a week
• kicking the cigarette habit
• avoiding saturated fat intake
• decreasing body weight

For others, medications may be needed. Because raising HDL is complicated, you should work with your physician on a therapeutic plan.

Lowering blood cholesterol through increased physical activity, weight loss, smoking cessation, and proper diet lowers that risk.

However, blood cholesterol is very specific to each individual and, for that reason, a full lipid profile is an important part of your medical history and important information for your physician to have. In general, healthy levels are as follows:

• LDL - less than 100 milligrams/per deciliter (mg/dL)
• HDL - less than 40 mg/dL puts you at higher risk for heart disease
• A total cholesterol level below 200 mg/dL is considered desirable

Always consult your physician for more information.