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Cholesterol Drug Can Save Heart Patients

Thu., July 6, 1995, midnight

The anti-cholesterol drug Zocor can prolong the lives of heart disease patients, the government said Wednesday, the first time it has declared such an effect for cholesterol medicine. Doctors urged heart patients to get tests as a step toward possible treatment.

The U.S. Food and Drug Administration said it will allow Merck & Co. to relabel the drug to show it has been proved to reduce deaths by lowering cholesterol.

“The message to patients today is: If you have heart disease, you need to know your cholesterol level, and … in most cases, you’re going to require a drug” to lower it, said Dr. Suzanne Oparil, past president of the American Heart Association.

Lowering cholesterol long has been considered a way to stave off heart disease. But doctors were reluctant to prescribe anti-cholesterol drugs for people who already have heart problems because the fat’s damage to arteries already had been done.

Now, scientists are accumulating evidence that aggressively fighting cholesterol in these patients - dropping it fast and to ultra-low levels - saves lives.

The FDA said it will allow relabeling of Zocor to indicate that. A five-year study of 4,400 coronary patients found Zocor lowered deaths from heart disease by 42 percent and also significantly reduced non-fatal heart attacks and the need for rehospitalization.

Seeing that on the drug’s label should persuade doctors to prescribe cholesterol medication to an estimated 4 million heart disease patients who retain high cholesterol levels despite a low-fat diet, said Dr. James Cleeman of the National Cholesterol Education Program at the National Institutes of Health.

“There will be an additional push to the practicing physician to recognize this is a bene ficial thing to do,” said Cleeman, whose group is considering ads urging patients to get checked.

The FDA decision is the latest development in the fierce marketing battle among cholesterol medicines. Some 900,000 Americans currently take Zocor, which has worldwide sales of $1 billion a year.

Zocor is considered the most potent of a class of anti-cholesterol drugs called statins. But there is growing evidence that Zocor’s relatives provide similar benefits, meaning that patients whose cholesterol dropped satisfactorily on a competing drug probably shouldn’t switch, Cleeman said. And the FDA last spring allowed competitor Pravachol to advertise that it helps reduce heart attacks.

Heart disease patients must dramatically drop the so-called “bad” portion of cholesterol, called LDL, to below 100 milligrams per deciliter of blood, say new guidelines issued Saturday by the heart association. That is 60 milligrams lower than recommended for the general public.

Dropping cholesterol doesn’t wipe existing plaque out of arteries. But new studies show it appears to make that fat build-up more stable and less likely to form clots that cause a heart attack or stroke.

Any heart disease patient who needs dramatic reduction in cholesterol is eligible for the medication, Cleeman said. The Zocor trial recorded a 35 percent drop in LDL.

Does that mean people with high cholesterol but not heart disease could benefit from aggressive treatment, too? Nobody knows yet.

“If I were in that situation, I would want to have aggressive cholesterol reduction, but the study doesn’t say that,” Oparil said.

The statin drugs generally have mild side-effects. However, Zocor is not for use by people with liver disease and women who are pregnant or breast-feeding, and it occasionally can cause muscle disease.

xxxx Eating right A low-fat diet alone - less than 7 percent of calories from saturated fat and less than 200 milligrams a day of cholesterol - can drop LDL by 10 percent.

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