updated 7/20/2005 5:54:27 PM ET 2005-07-20T21:54:27

Cholesterol-lowering statin drugs do not help severely ill diabetics, and may even raise their risk of a deadly stroke, a study found.

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In the study, patients on Lipitor were twice as likely to die of a stroke.

It was the first major test of statins in diabetics who need dialysis machines to remove wastes from their bloodstream because their kidneys cannot do the job. The results are surprising because previous research showed Lipitor helped less severely ill diabetics.

Dr. Robert Stanton, who is chief of kidney diseases at Joslin Diabetes Center in Boston and was not involved in the study, said it may be too late to start diabetics on statins once their kidneys have failed.

The study was funded by Lipitor’s maker, Pfizer Inc., and involved 1,255 Europeans with Type 2 diabetes, in which the body cannot properly use insulin. The findings were reported in Thursday’s New England Journal of Medicine.

More 120,000 Americans are on dialysis because of diabetes, and they have higher risks of heart disease, stroke and deaths than the general population and other diabetics. Lipitor is the world’s most-prescribed medication. It and other statins have dramatically lowered such risks by reducing levels of LDL, or “bad” cholesterol.

The study, led by Dr. Christoph Wanner at the University of Wurzburg, Germany, tested a relatively low dose of Lipitor — 20 milligrams a day — against dummy pills and found virtually no difference four years later in participants’ combined risk of heart attacks, strokes and death.

This happened even though the drug reduced LDL levels to an average of 72 milligrams per deciliter of blood, close to the target of 70 that new federal cholesterol guidelines recommend for people at very high risk of heart disease.

There were 27 fatal strokes among the 619 people on Lipitor versus 13 among the 636 in the placebo group, a result the authors said was unexplained and could be just a chance finding, considering that previous research showed a benefit from the drug.

“It’s definitely a concern, but I don’t know from a single study that you can say for sure you shouldn’t use it in this population. It certainly raises your alarm levels,” Stanton said.

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