It may be that ultralow LDL is safe--but how about the safety of the high-dose statins themselves? No one wants another Baycol. That statin was removed from the market in 2001 following 31 deaths in this country from what's called rhabdomyolysis, a condition in which the muscles dissolve and the kidneys may shut down. Guidelines issued by the American College of Cardiology (ACC) and the American Heart Association (AHA) in the wake of the withdrawal specified that statin doses should be no higher than needed in order to meet the target LDL goals, and none of those goals are below 100 mg/dL.
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There isn't much question that all statins can cause joint soreness and muscle pain, sometimes worse, in some people. But as is true of such side effects in general, establishing cause and effect can be difficult. Patients in clinical trials report muscle aches and joint pain at about the same rate whether they are in a statin-taking group or a placebo group. Some problems seem to occur more often at higher doses; others are absent in study patients taking high doses but reported for low doses. The general advice for patients is to listen to your body and tell your physician if something feels strange or wrong. You may need a lower dose or a different statin. And while there has never been a reported case of liver failure caused by statin use, liver enzymes need to be checked regularly.
The newest statin, Crestor, is extremely effective at lowering LDL. But it was approved last year only after AstraZeneca, its marketer, took an 80-mg dose off the table because of the Food and Drug Administration's concerns about possible kidney damage. Last September, Group Health Cooperative, a large health maintenance organization based in Seattle, decided not to include Crestor in its coverage. "We lacked evidence that it reduced cardiovascular disease, we lacked evidence of long-term safety, and we had three other statins that were cost effective and we knew quite a bit about," says Jim Carlson, director of clinical pharmacy services.
Unique? Earlier this month, Public Citizen Health Research Group, a consumer organization in Washington, D.C., petitioned the FDA to withdraw Crestor from the market. The petition cited the death of one American woman and more than 20 reports in the United States, Canada, and the United Kingdom of patients who experienced severe muscle breakdown, kidney damage or failure, or abnormal bleeding. "Crestor is uniquely dangerous," says Sidney Wolfe, director of the group. "It never should have been approved at all." AstraZeneca calls the claims "misleading, irresponsible, and needlessly alarming to patients." The FDA has not responded to the petition.
In the real world, a drug, no matter how good, can't work if patients don't get it--or if they get it but don't take it. Both happen frequently. Studies show, for example, that when patients hospitalized because of a heart attack or uncontrolled angina are put quickly on a statin and kept on it when they are discharged, the possibility that they will return because of another episode is reduced significantly. Accordingly, ACC/AHA guidelines published in October 2002 call for hospitals to start such patients, if their LDL level is high, on a statin within 24 to 96 hours.
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