X-Message-Number: 17389
From: "Mark Plus" <>
Subject: "Rest easy, statin users"
Date: Sun, 26 Aug 2001 11:31:42 -0700

http://www.usnews.com/usnews/issue/010903/health/stat.htm

Science & Ideas 9/3/01








Rest easy, statin users
Benefits dwarf risks for these cholesterol drugs



By Avery Comarow


Suppose you're on a medication that could cut the risk of having a heart 
attack by one third and the risk of dying from one by more than 40 percent. 
Then comes the news that the drug itself poses a 0.000017 percent risk of 
death. Would you stop taking it?





Some would. Early last month, Baycol, a relatively new member of the 
powerful cholesterol-lowering class of drugs called statins, was withdrawn 
from the United States because of 31 deaths from rhabdomyolysis, a condition 
in which muscle tissue breaks down. That got some doctors' phones ringing. 
Then last week the Health Research Group, an arm of Ralph Nader's Public 
Citizen advocacy organization, called for the Food and Drug Administration 
to require the remaining five statins to carry bold warnings because they, 
too, occasionally cause rhabdomyolysis. The ringing escalated.


"In the last couple of days we've gotten at least a hundred phone calls," 
cardiologist Alan Brown, medical director of the 5,000-patient lipid clinic 
at Midwest Heart Specialists in Naperville, Ill., said last week. Persuading 
some patients to stay on their statin, he lamented, "is like telling them to 
take arsenic."


Comforting numbers. It has been known from the beginning that a few people 
on statins will develop rhabdomyolysis, es- pecially if they are taking 
certain other drugs. The Merck Manual, a basic physician's guide, emphasizes 
the risk with italicized type, naming several drugs to avoid. Baycol was 
considered especially risky. Yet many of the patients who died were on a 
high dose and were taking gemfibrozil, a cholesterol-lowering drug that 
should be shunned when taking any statin but especially Baycol, as both the 
Merck Manual and Baycol's labeling warn.


For the five statins still on the market, however, the numbers are 
reassuring. Roughly 11 million prescriptions for Baycol had been written 
when it was withdrawn. From October 1997 to January 2001, nearly 300 million 
prescriptions were written for the other five, which the Health Research 
Group's statistics link to 385 cases of rhabdomyolysis and 52 deaths. That 
works out to less than 1 chance in 750,000 of getting rhabdomyolysis and 1 
in 5,747,000, or 0.000017 percent, of dying from it. "The odds of a serious 
bleed from aspirin can be 1 in 50,000," observes Brown, who has had two 
rhabdomyolysis cases in 17 years both reversed by stopping the drug.


Tragedy can almost always be headed off. "I warn patients all the time: 'If 
you have muscle aches and pains when you start this drug, call me,' " says 
Paul D. Thompson, director of preventive cardiology at Hartford Hospital in 
Connecticut. Unless, he generally adds with a grin, they climbed a mountain 
the day before.



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