December 10, 2002
By Jane E. Brody
The New York Times
Statins have been hailed as miracle drugs for their ability to prevent deaths from heart attacks by lowering cholesterol.
Some doctors go so far as to say the statins have had a greater effect on heart disease than anything else introduced in the last 50 years.
Last year, a national group of experts issued guidelines saying statins should be prescribed to some 36 million Americans, three times as many as were taking them then, to reduce their risk of heart disease.
In addition to protecting people at high risk, statins protect people who have already suffered one heart attack. Three large studies have shown that statins reduce the risk of second heart attacks by 30 percent and the risk of death from second heart attacks by 40 percent.
There are also strong hints that statins may protect against strokes, Alzheimer's disease and osteoporosis and may perhaps one day be useful in treating multiple sclerosis and other autoimmune diseases.
Given their apparent wide range of actions, statins have been called the modern-day equivalent of aspirin. Some experts have even suggested that they be sold over the counter.
But like aspirin and all other drugs, statins sometimes cause serious side effects. The most serious involves the muscles, a disorder called rhabdomyolysis, rare but debilitating and deadly if not detected in its early stages.
In August 2001, Bayer voluntarily recalled cerivastatin, marketed as Baycol, after 31 people died from rhabdomyolysis caused by the drug.
This complication occurs far less often with the five statins still on the market, but any and all of them can occasionally cause muscle disorders, even years after the drugs have been used with no apparent ill effects.
And, it appears, many patients are unaware of the signs of trouble associated with statins, and many prescribing doctors fail to warn patients about dangerous drug interactions or to perform the periodic tests needed to assure continued safe use of a prescribed statin.
For example, last summer an 82-year-old Kansas woman died as a result of longstanding but undetected muscle disease caused by the statin she had been taking for years to control her cholesterol.
For the entire time she was taking it, the woman experienced muscle pains that were never properly attributed to the drug. She even had a shoulder operation, which did nothing, of course, to cure the drug-induced pain that might have been correctly diagnosed through a simple blood test.
Then she was mistreated with an antifungal agent for skin lesions that actually resulted, not from a fungus, but from the muscle breakdown caused by the drug.
When combined with statins, the antifungals can greatly increase the risk and severity of muscle disorders. Within three months, the woman's condition worsened and she became so weak she could not stand or breathe on her own. Two weeks later, she was dead.
Statins may also cause a liver disorder in about 1 percent of patients. Because of that, everyone taking them should have a periodic blood test to spot early signs of trouble.
How Statins Help
The five statins now on the market are Lipitor (atorvastatin), Mevacor (lovastatin), Zocor (simvastatin), Pravachol (pravastatin) and Lescol (fluvastatin).
They all work to lower blood levels of cholesterol by the same mechanism: they inhibit a liver enzyme called HMG CoA reductase that enables the liver to make cholesterol.
The liver is the body's main source of cholesterol, a fatty alcohol needed to form important hormones and perform other critical cell functions.
When the liver cannot make its own, it removes cholesterol from the blood to fulfill these bodily needs. Thus, blood levels of cholesterol fall and the tendency for arteries to become clogged with fatty deposits is reduced.
Furthermore, statins reduce only the levels of the so-called bad cholesterol, L.D.L., or low-density lipoprotein, which promotes arterial clogging. Statins can also lower another damaging blood fat, triglyceride, somewhat.
But the "good" cholesterol — protective H.D.L., or high-density lipoprotein, which acts like an arterial drain cleaner — actually rises in most people who take a statin drug.
But while cholesterol reduction may be the main effect of statins, the drugs are thought to perform in several other ways to reduce cardiovascular risk.
They appear to stabilize the deposits on artery walls, reducing the chance that clumps will break loose and block major vessels.
They also relax blood vessels, inhibit clotting and may promote the
growth of new vessels, all actions that would make heart attacks and strokes
© Copyright 2002, The New York Times Company