ROANOKE TIMES Copyright (c) 1996, Roanoke Times DATE: Tuesday, July 9, 1996 TAG: 9607090063 SECTION: NATL/ITNL PAGE: A-1 EDITION: METRO DATELINE: WASHINGTON SOURCE: Associated Press NOTE: Below
The anti-cholesterol drug Pravachol can now advertise that it lowers by a third the risk of a first heart attack in otherwise healthy people with high cholesterol.
The Food and Drug Administration approved a label change last week that will allow Pravachol to become the first anti-cholesterol drug to be designated as reducing the risk of a first heart attack. Up to one-third of first heart attacks are fatal - and survivors are five to seven times more likely to suffer another.
Manufacturer Bristol-Myers Squibb will formally unveil the new label today.
Other drugs aggressively advertise that they lower the risk of second heart attacks and death from heart disease, yet just a fourth of heart patients take cholesterol medicine. Half of U.S. adults are thought to have cholesterol levels over 200, when the risk begins to climb.
But doctors have long debated how risky high cholesterol is when it's the only symptom of heart disease in otherwise healthy patients.
In November, Scottish doctors presented a study, funded by Bristol-Myers, of 6,500 otherwise healthy men with cholesterol levels between 250 and 300 who took Pravachol or a dummy pill for five years. Pravachol patients had 31 percent fewer first heart attacks and were 32 percent less likely to die from heart disease.
Based on that study, the FDA approved labeling Pravachol as a preventer of first heart attacks, a move that could educate doctors who may have missed the Scottish report.
Pravachol worked by lowering the so-called "bad" cholesterol, or LDL, in patients' blood by 26 percent, said Dr. James Cleeman of the National Institutes of Health's National Cholesterol Education Program. Pravachol, known chemically as pravastatin, is one of a class of four ``statin'' drugs that all appear potent enough to lower LDL by such large amounts, he said.
The Pravachol study ``is conclusive confirmation that when you lower cholesterol in people without heart disease, you get very substantial benefits,'' Cleeman said. ``The key here is lowering the LDL cholesterol sufficiently, and the statin drugs seem to be the best LDL-lowering agents we have.''
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