Diabetes Treatment Risk Not Found in 2nd Study

By Rob Stein
Washington Post Staff Writer
Thursday, February 14, 2008

One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk.

The seemingly conflicting findings, released yesterday, stoked the uncertainty about the best strategy for treating Type 2 diabetes, one of the most common health problems in the United States and elsewhere.

"This unfortunately just makes things more confusing," said Richard Kahn of the American Diabetes Association. "I think patients will be confused. I think doctors will be confused. So I think the message is: 'Don't do anything until we get this sorted out.' "

Federal health officials said there is a variety of possible explanations for the differing findings, and they planned to meet with their counterparts at the international study to try to explain the results.

"Hopefully when we sit down and look at the data, we'll come up with some mutual conclusions," said Denise Simons-Morton of the National Heart, Lung and Blood Institute.

More than 21 million Americans have Type 2 diabetes, which has become increasingly common because of the obesity epidemic. The disease causes blood-sugar levels to rise abnormally high, making patients prone to a host of complications, including blindness, nerve damage, kidney failure, heart attacks and strokes.

Patients typically try to lower their blood sugar through diet and exercise, or by taking drugs such as insulin or metformin, and researchers have long thought that getting blood-sugar levels as close to normal as possible would be most beneficial.

Last week, researchers at the National Institutes of Health surprised experts when they announced their preliminary analysis of an ongoing study involving more than 10,000 patients in the United States and Canada. They found 54 more deaths in the group that had intensive therapy to lower their blood-sugar levels than in the group that received standard treatment. The finding prompted organizers to halt the part of the study in which subjects were receiving the most intensive treatment.

The announcement about the U.S.-based study, known as Accord, prompted a panel monitoring a similar study known as Advance to conduct a preliminary analysis of its own data, which involve more than 11,000 patients in Europe, Asia and Canada, said study director Anushka Patel of the George Institute for International Health in Australia.

"Because of the Accord results, we felt we needed to ask our data safety and monitoring board to look at the data," Patel said. Like the Accord trial, the Advance study involved patients at high risk for heart problems. The patients were 66 years old on average.

The Advance analysis found no similar increase in deaths among patients receiving the most intense therapy for an average of five years, she said.

"There is no sign of the increased mortality that was apparently evident in the Accord study," Patel said in a telephone interview. "It's reassuring."

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