Last Updated: 2002-08-02 13:04:03 -0400 (Reuters Health)
By Alicia Ault
NEW YORK (Reuters Health) - Cholesterol-lowering drugs called statins are one of the most effective weapons in the battle against heart disease and they are safe, according to a consensus statement by the American Heart Association (AHA), the American College of Cardiology (ACC), and the National Heart, Lung and Blood Institute (NHLBI). The consensus statement, which is a reiteration of these organizations' prior positions, will be published in several medical journals in August.
The groups are also jointly issuing new guidelines for health professionals to address concerns about statins that came up after last August's recall of Baycol, a statin that was made and sold by Bayer.
"The principal reason for the AHA, ACC, and NHLBI getting together to make this statement was to counter the growing concern that these drugs are dangerous and have lots of side effects," said Dr. Richard Pasternak, director of preventive cardiology at Massachusetts General Hospital, and an ACC spokesman.
The guidelines "lay out how people should be monitored, and the kinds of groups more likely to have trouble," Pasternak told Reuters Health.
"For the vast majority of people," he said, statins "are risk-free."
Dr. Claude Lenfant, NHLBI director, said, "We hope this joint advisory will give physicians a good appreciation of appropriate usage of statins and how to monitor for side effects."
The Food and Drug Administration (FDA) found that Baycol was associated with several dozen deaths, as well as hundreds of adverse events related to muscle weakness and a more severe condition called rhabdomyolysis, in which the muscle breaks down. The FDA said all statins have muscle weakness listed as a potential side effect, but that there was no indication that any other drug in the class caused severe problems.
The advocacy group Public Citizen disagreed and petitioned the FDA to add a large warning to all statins about the potential for severe muscle weakness and wasting. Nothing has come of the request.
The ACC and the AHA initially said they believed the severe muscle side effects were limited to Baycol.
After a more in-depth review of existing and on-going research and the FDA's adverse reaction database, the two groups, along with the NHLBI, said they still believe statins are safe, and they developed new guidelines to make sure patients are closely monitored for side effects.
The guidelines help identify patients most at risk for muscle soreness and weakness, which includes people who are extremely old, those who have a small body frame and are frail, those who have more than one severe chronic disease (such as kidney disease and heart disease), and those taking other medications that statins might interact with.
With Baycol, people who also took the cholesterol-lowering drug Lopid (gemfibrozil), a member of the fibrate class of drugs, seemed to have a higher rate of fatal muscle breakdown.
Pasternak said that muscle weakness and rhabdomyolysis was much higher with Baycol than with other statins. Only one in 1,000 patients taking statins will have some muscle soreness, but fatal rhabdomyolysis has been detected in less than one in 1 million people, he said.
General aches and pains that occur in the course of normal, daily living should not concern people taking statins, said Pasternak. But, people "should be reporting any serious muscle problems to their physician, as well as any new and unexpected weakness, or the presence of brown urine."
"The bottom line is that when statins are given properly and monitored appropriately, they can do a tremendous amount to reduce cardiac risk," Pasternak said.
The guidelines are published on the ACC, AHA, and NHLBI websites, and will appear in the August 7 issue of the Journal of the American College of Cardiology and the August 20 issue of Circulation.
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