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Intense diabetes study is halted

An aggressive blood sugar trial is found to be high-risk.

By Washington Post
Published February 7, 2008

WASHINGTON - Aggressively driving blood sugar levels as low as possible in high-risk diabetes patients appears to increase the risk of dying from a heart attack or stroke, according to a major government study that stunned and disappointed experts.

The discovery, announced Wednesday, prompted U.S. officials to halt one part of the huge trial immediately, so thousands of the Type 2 diabetes patients could be switched to less intensive treatment.

"Our primary concern is to protect the safety of our study volunteers," said Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, the study's sponsor.

Although the reason for increased risk remains a mystery, Nabel and other experts stressed that the benefits of blood sugar control have been well-established for diabetics and that patients should not make changes in their care without consulting a doctor.

But the findings were a surprise to researchers, who expected to see a clear benefit from the lower sugar levels, and will force experts to reassess their thinking about how to treat one of the nation's leading health problems.

"This presents a real dilemma to patients and their physicians," said Richard Kahn, chief scientific and medical officer for the American Diabetes Association. "How intensive should treatment be? We just don't know."

An estimated 21-million Americans suffer from Type 2 diabetes, the most common form of the disease, and the number has been increasing because of rising obesity.

The study involves 10,251 Type 2 diabetes patients ages 40 to 82 in the United States and Canada at high risk for heart disease. A panel monitoring the study alerted organizers that 257 patients receiving the intensive treatment had died, compared with 203 receiving standard treatment. The patients were in the study for an average of four years.

Information from the New York Times was used in this report.

[Last modified February 7, 2008, 01:20:49]