Roanoke Times Copyright (c) 1995, Landmark Communications, Inc. DATE: THURSDAY, July 6, 1995 TAG: 9507060074 SECTION: NATIONAL/INTERNATIONAL PAGE: A-5 EDITION: METRO SOURCE: Associated Press DATELINE: WASHINGTON LENGTH: Medium
The Food and Drug Administration said it would allow Merck & Co. to relabel the drug to show it had been proven 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 has long been considered a way to stave off heart disease. But doctors were reluctant to prescribe anti-cholesterol drugs for people who already had 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 would 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 nonfatal 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 beneficial 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 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.
by CNB