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Diabetes Trial Halted After Deaths

Posted on: Thursday, 7 February 2008, 00:40 CST

The U.S. National Institutes of Health took the rare step Wednesday of abruptly halting a trial of aggressive treatment for Type 2 diabetics after a surprisingly high number of deaths among patients receiving the new drug therapy.

The trial was halted 18 months early, after 257 deaths occurred in the aggressively treated patients, compared to 203 deaths in the group receiving standard care.

The drug therapy used in the trial was designed to push blood sugar to extremely low levels.  But the trial results have now cast doubts on such aggressive approaches, particularly in high-risk patients.

Over 21 million people in the U.S. have diabetes, a condition where the body can’t properly regulate blood sugar, or glucose.  High blood sugar over time damages blood vessels, and diabetics have an increased risk of heart disease.  Type 2 Diabetes, the most common form, is linked to obesity, which in turn harms the heart.   

The study, named ACCORD, included over 10,000 patients and aimed to determine whether or not lowering blood sugar to near-normal levels would help protect high-risk diabetics.   Current guidelines for diabetes treatments do not call for lowering blood sugar to near-normal levels.

Scientists cannot yet explain the additional deaths.  The participants’  blood sugar levels weren't too low, a condition known as hypoglycemia.  And an examination of the multiple medications used, including the drug Avandia that is suspected of heart risks, showed no sign that any were to blame.

The study's death rate was actually well below what is typically seen in Type 2 diabetics, probably due to the extra care and monitoring the participants received as part of the research.

Moreover, the aggressively treated patients suffered about 10 percent fewer heart attacks than their counterparts, said Dr . William Friedewald of Columbia University, who helped monitor the study, in an Associated Press report.

"However, it appeared that if a heart attack did occur, it was more likely to be fatal" in that group, Friedewald said. "In addition, the intensive treatment group had more unexpected sudden deaths, even without a clear heart attack."

For now, the NIH advises diabetics with heart disease against achieving near-normal glucose, but instead to aim for a level long described as optimal for all diabetics - around 7 on a measurement scale known as the A1C.

The A1C test tracks average glucose levels over two or three months. People without diabetes have A1C levels as low as 5.  The American Diabetes Association has long recommended that diabetics aim to get their A1C level below 7, far below the long-common 8 or 9. Every point-drop lowers the risk of serious complications, such as blindness or kidney failure, by 25 percent to 40 percent.

Recent research shows that about half of U.S. patients have succeeded, and that "this overall level of glucose control appears to be of great benefit rather than harm," the ADA told Associated Press.    Getting too far below an A1C of 7 is very difficult, and very few patients outside of research studies have succeed.

The NIH study aimed to have aggressively treated participants achieve below a level of 6. Only half got below 6.4, compared to an A1C of 7.5 among study volunteers getting standard treatment.

The study’s findings contradict previous research suggesting that the lower diabetics can make their blood sugar, the better.

"We obviously were surprised. We were hoping for a positive outcome, but the reason we do this research is we don't know that," study researcher Dr. Hertzel Gerstein of Canada's McMaster University told Associated Press.

The contradiction between this study and previous research had specialists cautioning Wednesday that it's too soon to know if the new study was a fluke, or a real indication of how specifically tailored to each patient's risk factors diabetes treatments must be.

"Everything else has suggested, for 50 years or more, that tight control was good," Dr. James Dove, president of the American College of Cardiology, told AP.  "We've got half a century of literature that is put on the back burner right now by one study. ... It may not be the final decision."

The NIH said their announcement does not alter their standard treatment guidelines. However, the NIH's National Heart, Lung and Blood Institute added that diabetics with heart disease should stop at a level of 7 rather than dip below, while researchers try to understand why such a high number of deaths occurred in the study.

All the study participants have been switched back to standard therapy, and their health will be tracked through June 2009.

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On the Net:

U.S. National Institutes of Health

ACCORD clinical trial website

Source: redOrbit Staff

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