Are Statins Right for You?

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Although the first statins were approved in the U.S. in 1987, they didn't really take off until 1994, when researchers in Scandinavia proved that simvastatin (brand name Zocor) could significantly decrease a heart patient's risk of dying from a second heart attack. After investigators showed that both simvastatin and pravastatin (Pravachol) could cut the number of first heart attacks among those with high cholesterol, doctors assumed that all statins could do likewise.

Their next question had even wider implications: Could statins decrease the risk of heart attack in people with "normal" cholesterol levels and no history of heart disease? But here researchers ran into an ethical dilemma. Considering everything they knew about the effectiveness of statins, would it be fair in a test of their theory to withhold the drugs from those who might benefit from them but would be given a placebo, or dummy pill?

Meanwhile, the dietary-supplement industry got into the act after it discovered that Chinese red yeast fermented on rice contains small amounts of the same active ingredient found in lovastatin (Mevacor). The FDA tried to ban the supplement's sale in the U.S., but the action has become the subject of a lengthy court process. The controversy hasn't stopped Merck, which manufactures Mevacor and Zocor, and Bristol-Myers Squibb, which produces Pravachol, from arguing that they should be allowed to sell their pharmaceutical-grade products at similarly low doses to the general public.

The companies did propose certain restrictions. Even with over-the-counter approval, statins would not be available on drugstore shelves next to cold medications and aspirin. A patient would have to produce a blood test for a pharmacist showing that his or her cholesterol levels met whatever the eventual criteria would be for moderately high levels. Only the pharmacist would be able to review that test and dispense the drug. But a panel of experts was unconvinced, and advised the fda last summer to deny the petition, at least until further studies are completed.

And so things now stand. In the absence of new clinical trials, the researchers who reported in the British Medical Journal used complex mathematical analyses of four previous studies to conclude that statins can reduce the risk of suffering a heart attack even in men and women with normal cholesterol levels and no signs of heart disease. Since this population is fairly healthy, however, doctors might need to treat 250 or more people to save a single life. A bargain for the one whose life is spared, but not so great for the majority, who would not only bear the expense but would also be exposed to potential side effects from a treatment that might turn out to have been unnecessary.

So for the time being, doctors consider the following individuals to be potential candidates for treatment with statins: those whose LDL is 190 mg/dl or higher; those whose LDL is 160 mg/dl or higher and who have at least two risk factors for heart disease, such as smoking, diabetes or high blood pressure; and those whose LDL is 130 mg/dl or higher and who suffer from heart disease.