Major diabetes, heart disease study halted after deaths

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 near normal levels, 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 study of about 10,000 patients, 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 (NIH) 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 a 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 that is suspected of being heart-risky, showed no sign that any were to blame.

Half the patients were treated with conventional drugs and lifestyle modifications targeted at reducing their blood levels of sugar to 7 to 7.5 percent, the level most commonly targeted by physicians. The other half received the same drugs, but in higher doses and multiple combinations, to reduce sugar levels to about 6 percent, the same level as in healthy individuals. Most had levels of about 8.2 percent at entry into the study, a little higher than the average diabetic.

Dr. Irl Hirsch, a diabetes researcher at the University of Washington, said the study's results would be hard to explain to some patients who had spent years and made enormous efforts, through diet and medication, getting and keeping their blood sugar down. They will not want to relax their vigilance, he said.

"It will be similar to what many women felt when they heard the news about estrogen," Hirsch said. He added that organizations such as the American Diabetes Association and the American Association of Clinical Endocrinologists would be in a quandary. Their guidelines call for blood-sugar targets as close to normal as possible. And some insurance companies pay doctors extra if their diabetic patients get their sugar levels very low.

The patients receiving intensive treatment will be switched to standard treatment as soon as possible, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.

The findings contradict previous 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 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.

Material from the Los Angeles Times and The New York Times is included in this report.