Deaths prompt U.S. to halt diabetes study
WASHINGTON — The government abruptly halted aggressive treatment in a major study of diabetes and heart disease after a surprising number of deaths among patients who pushed their blood sugar to super-lows — findings that call into question a growing movement in diabetes care.
Wednesday’s move doesn’t affect health guidelines for most Type 2 diabetics, but it raises concern about a particularly vulnerable group: Patients at especially high risk of heart attack or stroke.
The 10,000-patient study, dubbed ACCORD, was supposed to answer a big question: Could pushing blood sugar to near-normal levels, below today’s recommended target, help protect these high-risk patients’ hearts?
Instead, the National Institutes of Health took the rare step of halting part of the study 18 months early — citing 257 deaths among aggressively treated patients compared with 203 among diabetics given more standard care.
That translates into an extra three deaths for every 1,000 participants per year, and researchers were at a loss to explain why. Diabetics’ blood sugar wasn’t too low, a condition known as hypoglycemia. And a close look at the multiple medications patients used, including the drug Avandia, which is suspected of being a risk to the heart, showed no sign that any were to blame.
Ironically, the study’s death rate was well below what doctors usually see in Type 2 diabetics, probably because of the extra care and monitoring they received as part of the research.
Moreover, the aggressively treated patients suffered about 10 percent fewer heart attacks overall than their counterparts, said Dr. William Friedewald of Columbia University, who helped monitor the study.
“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.”
So for now, the NIH’s message: Diabetics with heart disease shouldn’t strive for near-normal glucose, but to a level long described as optimal for all diabetics — around 7 on a measurement scale known as the A1C.
“We obviously were surprised. We were hoping for a positive outcome, but the reason we do this research is we don’t know that,” said a study researcher, Dr. Hertzel Gerstein of McMaster University in Hamilton, Ontario.
The findings contradict research suggesting that the lower diabetics can make their blood sugar, the better. That had specialists cautioning Wednesday that it’s too soon to know if the finding among heart patients was a fluke, or a real sign of how exquisitely tailored to each patient’s risk factors diabetes care must be.
“Everything else has suggested, for 50 years or more, that tight control was good,” said Dr. James Dove, president of the American College of Cardiology. “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.”
Some 21 million Americans have diabetes, meaning their bodies can’t properly regulate blood sugar, or glucose. Diabetics already are at increased risk of heart disease.
Type 2 diabetes, the most common form, is linked to obesity, which in turn harms the heart. Plus, high blood sugar over time damages blood vessels.
Tags: health, heart attack, heart attacks, intensive treatment, national institutes of health, obesity, risk, target