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New Drug Therapy May Reverse Atherosclerosis

Breaking News - March 2006 - Week 3

(Mar 15, 2006)

Healthcare in  the News

-- What if we could not only slow the buildup of artery-clogging plaque, but actually reverse the plaque buildup? Scientists may have succeeded in doing just that, turning back the clock in patients with heart disease.

Picture of a prescription pad and a pill bottle

Intensive cholesterol-lowering therapy using Crestor® - a powerful (and controversial) member of the statin family of drugs - not only reduced low-density lipoproteins (LDL, or "bad" cholesterol) levels but actually reversed atherosclerosis, better known as hardening of the arteries.

Other statin medications may halt disease progression, but have not been shown to reverse plaque deposits.

The findings were presented this week at the annual meeting of the American College of Cardiology (ACC), in Atlanta. The study will also appear in the Journal of the American Medical Association (JAMA) and is being released early online to coincide with the presentation at the ACC meeting.

"Previous similar studies with statins have shown slowing of coronary disease, but not regression. This regimen significantly lowered bad cholesterol, and surprisingly, markedly increased good cholesterol levels," says Dr. Steven Nissen of the Cleveland Clinic and lead author of the study.

Dr. Nissen, also president-elect of the ACC, continues, "We conclude that very low LDL levels (below current guidelines), when accompanied by raised HDL [high-density lipoproteins, or "good" cholesterol], can regress, or partially reverse, the plaque buildup in the coronary arteries."

Very Low LDL Levels May Help

While lower LDL cholesterol has been shown to reduce the risk of such events, doctors are not in agreement on how low to go, although, increasingly, evidence suggests that lower is always better.

In general, a healthy level for LDL cholesterol in the blood is less than 130 milligrams per deciliter (mg/dL).

However, for some individuals who already have coronary artery disease (CAD) and/or who have an increased number of risk factors for coronary heart disease, a physician may determine that the LDL cholesterol level should be kept lower than 130.

Recent studies have shown that those who are at highest risk for a heart attack should lower their LDL cholesterol level to less than 100, and that an LDL cholesterol level of 70 or less may be optimal for those individuals at the very highest level of risk.

The introduction of cholesterol-lowering drugs, called statins, in 1987 brought the hope that atherosclerosis could one day be reversed. That hope, however, has been elusive.

"The closest we came was when we got LDL down to 79, which we thought was fantastic but all we got was no [disease] progression," says Dr. Nissen.

Plaque Build-up Found to Be Decreased

For the newmanufacturer-sponsoredtrial, 507 patients at 53 healthcare centers in the United States, Canada, Europe, and Australia were given 40 milligrams a day of Crestor (generic name rosuvastatin). Crestor is the most recently introduced and one of the most potent of the statin family of drugs.

Plaque build-up was measured by intravascular ultrasound (IVUS) at the beginning of the study and two years later. The researchers reported information on 349 of the original 507participants.

Sixty-four percent of the patients showed regression of atherosclerosis, the researchers said.

And the average LDL levels fell from 130.4 mg/dL to 60.8 mg/dL, an average reduction of 53.2 percent. High-density lipoprotein (HDL, or "good" cholesterol) levels rose, on average,from 43.1 mg/dL to 49 mg/dL, a 14.7 percent increase. In general, a healthy HDL level is greater than 40 mg/dL.

"That's the lowest LDL ever that's been achieved in a clinical trial of this kind," Dr. Nissen says. "The 14.7 percent increase in HDL is also unprecedented. With that combination, we saw a large-scale regression, 7 to 9 percent of plaque volume."

"It certainly adds to the growing body of evidence to suggest that lower target levels of LDL may have additive value," adds Dr. Sidney Smith, professor of medicine at the University of North Carolina, Chapel Hill, former president of the American Heart Association (AHA) and co-chairman of the ACC/AHA Task Force on Practice Guidelines.

Benefits vs. Risks

"At this point, we can say that if you can get your patients to these very low levels of LDL with an intense statin regimen, particularly if it's accompanied by a major increase in HDL, then you are capable of partially reversing the disease," says Dr. Nissen. "That's a step forward."

Still, several questions remain.

The main question is whether the plaque reversal seen with Crestor will reduce cardiac events such as heart attack. The study did not evaluate the impact of Crestor on cardiac events.

Another questionis whether the benefits could be achieved with other statins or other cholesterol-lowering measures.

"My guess would be that the changes would be seen with other degrees of LDL lowering by statins and presumably by other mechanisms which would lower LDL, but we need to confirm it," says Dr. Smith.

Also, the study only looked at people who had already suffered one coronary event, such as a heart attack. It is unclear how this strategy would work in people who had not yet suffered such a fate.

Crestor has an acknowledged higher rate of adverse events, including rhabdomyolysis (breakdown of muscle tissue) andkidney failure, than other statins. The consumer advocacy group Public Citizen has petitioned the US Food and Drug Administration (FDA) to take the drug off the market.

Public Citizen is not likely to change its stance, despite the new findings.

"The study is a bit less impressive than perhaps is put forth," says Dr. Peter Lurie, deputy director at Public Citizen's Health Research Group.

"Many patients were lost to follow-up, and there is no comparison group, so we have no way of knowing if some other drug might not have accomplished exactly the same thing," he says. "It leaves many questions unanswered. I don't see a fundamental shift here in our position."

Even backers of the findings acknowledge that medical practice will not be altered by the merits of one study.

"Usually a single study doesn't change everybody's practice," Dr. Nissen says. "It changes the momentum and, with that momentum, you'll see more interest in this and people reaching lower LDL levels."

The bottom line, however, is the study findings support intensive statin therapy for high-risk patients with established coronary artery disease.

Always consult your physician for more information.

For more information on health and wellness, please visit health information modules on this Web site.

Facts About Cholesterol

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.

Cholesterol and other fats are transported in your blood stream in the form of spherical particles called lipoproteins.

High blood cholesterol is a significant risk factor in heart disease. 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.

Elevated cholesterol is a risk for many Americans. Consider these statistics:

  • About 107 million American adults have total blood cholesterol levels of 200mg/dL and higher, and of those about 38 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.

The two most commonly known lipoproteins are low-density lipoproteins (LDL) and high-density lipoproteins (HDL).

LDL 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.

LDL should be kept low, less than 130 mg/dL (or less, depending on a person's individual situation).

To help lower LDL:

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

HDL 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.

The HDL level should 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, medicine may be needed. Because raising HDL is complicated, you should work with your physician on a therapeutic plan.

Always consult your physician for more information.

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