Diabetes Treatment Risk Not Found in 2nd Study

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Speaking of conflicting studies:

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 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 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 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. "

She added that no additional information was available, including whether the study showed any benefit from more intensive treatment.

" We have to wait until we have the full data to make any conclusions about the benefits and risks, " Patel said.

Other researchers said it was difficult to interpret the findings before seeing details of both studies, which have not been published. Although the two studies were similar, there may be important differences in the patients studied or the treatments they received, they said.

" There's a lot we don't know, " said Buse, also of the American Diabetes Association and a member of the committee overseeing the Accord trial.

The patients in the Advance trial, for example, received a drug that is not available in the United States, Buse said. They could also have been healthier in some ways.

Another key issue is the specific blood-sugar levels achieved by the two studies, Buse and others said.

Blood-sugar levels are measured by a blood test known as hemoglobin A1C. The patients receiving intensive treatment in the Advance trial achieved a median A1C level of 6.4, compared with 7 for those on standard treatment, Patel said. While the levels achieved by intensive treatment in the two studies were similar, the level achieved by the standard treatment in the Accord trial was slightly higher, which could possibly account for the difference in outcomes, several experts said.

" That difference in the spread could make a difference, " said Kahn, adding that he hopes the situation will become clearer when the full results are published along with a third similar trial expected later this year.

" I think between the three of them, we'll be able to sort it out, " he said.