It's All About The Drugs High cholesterol
By John Helyar Reporter Associates Paola Hjelt, Lisa Munoz

(FORTUNE Magazine) – You'd think Mr. Cholesterol would have been routed in the past decade. Studies paint an ever starker picture of the danger posed by fatty deposits in the bloodstream. Anti-cholesterol "statins" like Lipitor and Zocor have proved able fighters and have become blockbusters. So why, in that time, has the percentage of people with high cholesterol risen to the point where one in five Americans has a problem? It is particularly pronounced in middle age; a 1999 study by the Centers for Disease Control and Prevention found that 37% of 45- to 64-year-olds had high total cholesterol (240 or above), about double the rate of people ages 20 to 44.

"There's a big cholesterol treatment gap," says Dr. Richard Pasternak, chief of preventive cardiology at Massachusetts General Hospital, who estimates that just half of Americans with high cholesterol are being treated for it. Pasternak helped write the latest guidelines of the National Cholesterol Education Program (NCEP), which reflect how much more is known about cholesterol than in 1993, when the previous guidelines came out. The NCEP nearly tripled, to 36 million, its tally of Americans who should be on statins. This partly reflects a decade of way too many fries--the obesity rate of people in their 50s, for instance, rose from 16.1% in 1991 to 25.6% in 2000. What's more, researchers understand better now cholesterol's culpability in a broad array of maladies, like diabetes. They can also better predict who's at risk of a heart attack and thus a candidate for the drugs, which block the liver's production of cholesterol.

The NCEP now recommends a tiered attack. By the old guideline, if your "bad" cholesterol--low-density lipoproteins, or LDL--was below 130 milligrams per deciliter (mg/dl), you were okay; if it was above 130, your doctor likely urged you to change your diet or whipped out the prescription pad. The new guidelines apply a formula (based on such factors as age, blood pressure, and family cardiac history) that predicts a person's risk of heart attack in the next decade. Anyone whose risk is above 20% should drive his LDL down under 100, according to the NCEP. A person who is relatively young and disgustingly healthy, on the other hand, can reach a 160 level before the alarm sounds. But while the recommendations have been public for seven months, many doctors have yet to change their ways, and many patients who are cardiac-events-in-waiting don't know about the new risk calculation.

Statins alone won't close the treatment gap, though proof of their potency continues to grow. A team at Oxford University recently completed the biggest-ever cholesterol study (20,000 people) and found that statins lower the risk not only of heart attacks but also of strokes. The study also found that statins are effective in a wider range of people than generally thought, including women and seniors.

Three problems with statins, however. They're expensive ($100-plus a month, which insurance pays for in most cases but not all); they can cause serious side effects (Bayer's Baycol was pulled from the market last summer after being linked to 31 deaths by severe muscle-cell breakdown); and they're ultimately only as good as the people who swallow them. A Cleveland Clinic study of 375 patients found their LDL counts dropped significantly less than the statin makers said to expect. That attests to the difference between clinical trials and real life, says study coordinator Dr. Dennis Sprecher: "People take this medication and immediately take cheesecake."

The NCEP guidelines emphasize not just statins but "therapeutic lifestyle changes": limiting foods with saturated fat to 7% of daily calories; eating food that's high in soluble fiber, like grains and citrus fruit; and exercising at least three times a week. But for at-risk people, the consensus now is that they should proceed directly to drugs. The NCEP standard: Anyone with high cholesterol and a 20% heart-attack risk belongs on statins pronto; anyone with less risk should first give clean living a three-month shot. The biggest problem remains what docs call noncompliance. High cholesterol just doesn't scare people the way malignant tumors do. It should.

--JOHN HELYAR