Cholesterol-lowering drugs known as statins could help just about anyone at increased risk for heart disease live longer, even those with normal cholesterol levels, according to the results of a large British study announced Tuesday.
The researchers who ran the study believe it shows that worldwide, eight times as many people could benefit from taking statins as are taking them now, even though about 25-million people are taking them already.
The study involved 20,000 volunteers and physicians at 69 hospitals. It proves the benefit of the medicines in numerous groups _ the elderly, women, people with normal cholesterol levels _ in which there was still uncertainty.
"These results are at least as important as previous findings for aspirin's effects on heart attacks and stroke," said Rory Collins of the University of Oxford. "In fact, statins are the new aspirin."
In the United States, about 12-million people take statins. Under treatment guidelines released this year by the federal government, about 36-million people have a clinical reason to take the drugs. That number is likely to be even higher if the findings of the new Heart Protection Study are broadly accepted. As measured by dollar value of sales, two of the 10 leading drugs in the United States last year were statins.
"To have one study that can tell you conclusively about each of these groups is a very important addition to the evidence," said James Cleeman, the physician who heads the federal government's National Cholesterol Education Program. "It's kind of one-stop shopping to have a lot of things come together in this one very large trial."
The first studies were done more than a decade ago on middle-aged men with high cholesterol who had already had a heart attack. Since then, research has steadily expanded the groups of people who benefit from taking statins. The drugs reduce the body's ability to synthesize cholesterol, a fatlike substance that builds up in arteries, stifling blood flow.
In the new study, whose results were presented Tuesday at a meeting of the American Heart Association in Anaheim, Calif., researchers recruited a diverse population of patients, all at higher-than usual risk of cardiovascular disease. One-third had had a heart attack; one-third had angina; and one-third had had a stroke, had arterial blockage in a leg, or were diabetics. (Diabetics are at such increased risk that as a group they're considered to have heart disease even if they don't yet have symptoms.)
In all cases, the patient's doctor was uncertain whether the person would benefit from a statin _ usually because the patient fell outside a group where the proof was clear-cut. About 20,000 volunteers were randomly assigned to take 40 milligrams of the drug simvastatin (sold in this country as Zocor) or a placebo that looked the same. The recruitment started in 1994, and the participants were followed for about five years.
The roughly 10,000 people taking placebo suffered 2,606 "cardiovascular events": nonfatal heart attacks, strokes, bypass operations or angioplasties. In the simvastatin-takers, there were 2,042 events. This amounted to about a 25 percent reduction in the risk of having an event.
The roughly 25 percent reduction in events was seen in women as well as men. It was seen in people whose LDL cholesterol, the most damaging kind, was below 116 milligrams per deciliter of blood, a range that's generally considered very healthful. It was seen in people over age 75. That last group was one a leading British heart specialist had advised not even be included in the trial because there was no reason to believe cholesterol-lowering drugs would help, said Richard Peto, one of the researchers.
Statins have been associated with muscle and liver problems in some previous studies, but did not appear to cause those problems in this one.
The researchers assume the findings would hold true for statins besides simvastatin.