ORLANDO, Fla., Mar 20, 2001 (United Press International via COMTEX) -- Researchers said Tuesday that a new cholesterol-lowering drug appears to be more powerful than any other such product now on the market.

In the halls of medical institutions and at medical meetings, the drug is nicknamed "superstatin" or "gorillastatin" because of its potency, said Dr. Richard Charles Pasternak, associate professor of medicine at the Harvard Medical School/Massachusetts General Hospital, Boston.

In a series of studies presented at the annual scientific session of the American College of Cardiology in Orlando, Fla., Dr. Evan Stein of the Metabolic and Atherosclerosis Research Center, Highland Heights, Ky., said that the new drug -- rosuvastatin -- lowered cholesterol levels in patients better than pravastatin, simvastatin and atorvastatin.

"These studies confirm the early promise of rosuvstatin as the most effective medication to reduce LDL cholesterol," Stein said.

LDL-cholesterol is known as the "bad" cholesterol because of its role in atherosclerosis, the process in which blood vessels become clogged and can cause heart attacks, strokes and other vascular problems. Formerly known as ZD4522, the drug's ability to markedly lower cholesterol was described in preliminary studies last year at the meeting of the European Society of Cardiology in Amsterdam as reported by United Press International.

Stein also reported that more patients on rosuvastatin were able to reach target levels of LDL-cholesterol, especially important among patients who are diabetic and have high cholesterol. High levels of cholesterol are associated with an increased risk of heart disease.

And at the same time that rosuvastatin was able to lower the harmful cholesterol, Stein said the drug also markedly raised HDL, the so-called "good" cholesterol which helps transport the blood fat from the body.

Also on the plus side, Stein said he could find no evidence in up to 18 weeks of use that there were any unexpected safety concerns with the drug. In studies, two patients out of 435 people on rosuvastatin developed transient increased levels of liver enzymes, but those laboratory findings resolved in one patient who continued on treatment, and the level decreased when the patient was taken off the drug. Some patients were taking other statin drugs in the trial; one patient out of 187 on atorvastatin had to be taken off treatment.

Just because rosuvastatin is effective in lowering cholesterol doesn't necessarily mean it will be embraced by physicians once the investigational drug receives licensing, said Dr. Dennis Sprecher, head of preventive cardiology at the Cleveland Clinic Foundation.

"You have to demonstrate it has value in outcomes as well," Sprecher said. He suggested that physicians might be conservative in using rosuvastatin until it can be shown that the drug not only lowers cholesterol, but also reduces heart attacks or deaths from heart disease or the need for patients to undergo invasive surgical procedures due to chest pain caused by atherosclerosis.

Other statin drugs have been tested in large clinical trials that have shown ability to reduce these heart disease-related events.

Sprecher also cautioned that medical science may be reaching the limits of how much cholesterol can be lowered by medical means. He said patient compliance in taking the medication long-term may be more a factor in how well the statin drugs can prevent heart attacks.

"Overall," Sprecher said, "rosuvastatin is a very effective drug in reducing cholesterol."

A spokesperson for AstraZeneca of Wilmington, Del., said that the company plans to file for Food and Drug Administration approval of rosuvastatin in mid-2001. If it passes FDA hurdles it could be licensed before the end of 2002.

By ED SUSMAN, UPI Science News

Copyright 2001 by United Press International.

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