Just three years ago, updated cholesterol guidelines almost tripled the number of Americans for whom cholesterol-lowering statin drugs are recommended to 36 million, or one out of five adults. Statins overtook antidepressants as the best-selling class of drugs in the United States, and the new guidelines promised to add more than $20 billion to drug company coffers each year.
Many of the additional people for whom statins were recommended did not yet have heart disease but were at moderately high risk and had LDL, or "bad" cholesterol levels, above 130 milligrams per deciliter.
This month, the recommendations were updated again, and millions more Americans with LDL levels between 100 and 129 found themselves in a new risk category.
Based on the results of five new studies, the experts from the National Cholesterol Education Program recommended offering these people the "therapeutic option" of taking a statin drug. What sensible person would forgo this opportunity to ward off heart disease?
But are the lower targets justified? It's not so clear. One of the new studies included 2,000 women with four or more risk factors for developing heart disease. Unexpectedly, the women randomly assigned to take the statin Lipitor developed slightly more heart disease than those given placebos.
Still, one study shouldn't negate the findings of the six earlier ones cited in the 2001 guidelines. But a closer look reveals that not a single one of those studies actually provides significant evidence that statins protect women who don't already have heart disease. Although millions of women are already taking statins, there is still no evidence from "gold-standard," large, randomized controlled trials to show they help.
Another of the new studies included 3,000 people between the ages of 70 and 82 at high risk of, but still without, heart disease. Treatment with a statin drug did not significantly reduce their risk of heart disease either. But it did significantly increase their risk of developing cancer -- by 25%. Again, this single study shouldn't negate the nine studies cited in the 2001 guidelines as evidence that statin therapy protects people over 65 from developing heart disease. But, again, when each of the nine references is examined in detail, not a single one provides significant evidence that statins help protect those without heart disease.
