Study - Most diabetics should get statin drugs

LONDON -- Most adult diabetics should be taking cholesterol-lowering drugs even if they have healthy cholesterol levels and no evidence of heart disease, a major new study has concluded.

The results, which found that statin drugs cut the risk of heart attacks, strokes and the need for angioplasty or bypass surgery in diabetics by one-third, emerge from the largest study ever to test the power of statins.

Experts say the findings, published this week in The Lancet medical journal, demand a change in current recommendations, which do not advise statin therapy for diabetics unless cholesterol levels are elevated.

Statins -- sold under such brand names as Zocor, Pravachol, Lipitor, Mevacor and Lescol -- are taken by 25 million people worldwide at risk of dying from heart disease. Diabetics do not generally receive cholesterol-lowering therapy, although they have a particularly high risk of heart trouble.

If the new findings are acted on, about 100 million diabetics worldwide would become candidates for cholesterol-lowering treatment, according to the researchers from Oxford University in England.

They estimated this could prevent about 1 million heart attacks, strokes and angioplasty or bypass operations each year worldwide.

"This research proves that statins can offer real benefits to many people with diabetes, helping them to avoid some of the life-threatening complications of diabetes," said Simon O'Neill of Diabetes UK, a patient advocacy group.

The study was partially financed by Merck & Co., which makes Zocor, the statin used in the research.

In the study, 5,963 diabetics aged 40 or older and 14,573 non-diabetics with artery disease were randomly given either 40 mg of Zocor or fake pills every day for five years. About 10,000 people were allocated the drug and another 10,000 the fake tablets.

About 25 percent of people assigned the fake pills had a heart attack, stroke or needed angioplasty or bypass surgery, compared with about 20 percent of those given the statins.

The study found that among both the diabetics and the non-diabetics with artery problems, the risk of such problems was about one-quarter lower in the people assigned statins than in those allocated the dummy pills.

Benefit underestimated

However, the investigators said the true benefit of statins was underestimated by those calculations because some people assigned fake pills ended up taking statins but were counted in the fake pill group, diluting the real difference between the treatments.

"We can estimate that the benefit that we saw -- a reduction of about 25 percent -- is about two-thirds of what the effect of actually using the tablets would be," said Dr. Jane Armitage, one of the study's investigators. She said the scientists estimated the true effect is a one-third reduction in the risk of heart attacks, strokes or artery operations.

About half the diabetics in the study had no evidence of heart disease. About half had normal or below-average cholesterol levels. Those patients seemed to benefit as much as the others, Armitage said.

"Statin therapy should now be considered routinely for all diabetic patients at sufficiently high risk of major vascular events, irrespective of their initial cholesterol concentrations," said epidemiologist Rory Collins, the study's leader.

Armitage said investigators stopped short of recommending statins for all adult diabetics because for some people newly diagnosed in their 20s or 30s, the risk of heart trouble may not be so high.

Dr. Lars Lindholm, a professor of public health and clinical medicine at Umea University in Sweden who was not connected with the research, said the evidence from the study for such a recommendation was clear.

"One could even go a step further and ask whether all patients with type II diabetes should be given a statin, regardless of their cholesterol value," he said.

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On the Net:

The Lancet, http://www.thelancet.com