DIABETES
"We have confounding issues," said Dr. James Dudl of Kaiser Permanente's Endocrine Clinic in San Diego, one of 77 research centers involved in the study.
"The question is, are these conclusions generalizable to most people with diabetes?" Dudl asked. "Right now, most of us are saying they are not."
For now, the American Diabetes Association is telling diabetics to keep taking their prescribed medications for reducing blood sugar and to see their doctors for re-evaluation.
Many diabetes experts note that the number of deaths reported for the study group was only one-third to half the mortality rate for the general population of diabetics. Participants in clinical trials tend to do better than the general population because they receive excellent care and adhere more strictly to their treatment regimen.
They're also reminding patients that lower blood sugar levels help prevent eye, kidney and nerve complications and the need for amputations.
Physicians are urging the study's leaders at the National Heart, Lung and Blood Institute in Bethesda, Md., to dig deeper for what ultimately caused the deaths.
More than 10,000 diabetics in the United States and Canada were enrolled for the clinical trial, dubbed ACCORD (Action to Control Cardiovascular Risk in Diabetes). Researchers wanted to see if aggressive methods to lower cholesterol, blood pressure and blood sugar levels would stem the rate of cardiovascular death among Type 2 diabetics.
In general, diabetics have two to four times the risk of acquiring cardiovascular disease compared with the general population. Of the roughly 284,000 diabetics who die each year in the United States, two-thirds of them die from stroke, heart attack or heart failure, according to the National Heart, Lung and Blood Institute.
The patients enrolled in the ACCORD study were at especially high risk for suffering a heart attack or stroke because they had a history of heart disease, smoking, obesity, high blood pressure or high cholesterol.
The clinical trial had progressed for seven years when researchers made their surprise announcement. The portion dedicated to aggressive control of blood sugar levels was halted 18 months early.
Safety monitors found that patients whose blood sugar was lowered to near the levels for nondiabetics - 6 or lower for the hemoglobin A1C - were more likely to die than people whose blood sugar was lowered between 7 and 7.9.
There were 257 deaths in the intensively treated group. That was 54 more than in the moderately treated group, or a difference of 14 deaths per 1,000 people versus 11 deaths per 1,000.
Dudl, the Kaiser doctor, said in an interview what many diabetes and heart disease experts nationwide have expressed on various medical Web sites. "My gut feeling is that the reason is in the medicine - one of the drugs or a combination of drugs used to treat diabetes," Dudl said.
Some doctors wondered whether certain patients became stressed from too much drug treatment.
"The intensive group had extremely rigorous treatment, with some patients taking four shots of insulin and three pills and checking their blood sugar levels four times a day," Dr. John Buse of the University of North Carolina wrote on theheart.org.
The ACCORD study's leaders said they found no evidence that patients died from heart attacks caused by particularly severe hypoglycemic shock. But some physicians said the condition is tough to detect.
"There will be a lot of people doing analyses on this study for weeks to come," said Dr. Athena Philis-Tsimikas, medical director of the Whittier Diabetes Institute.
THE FACTS
Diabetes occurs when the body does not produce or properly use insulin, a hormone that converts sugar, starches and other food into energy.
Genetics, diet, obesity and lack of exercise are underlying causes of the disease.
About 90 percent of diabetics are Type 2, in which the body cannot properly process insulin. In Type 1 diabetes, usually found in children and young adults, the body does not create insulin.
At least 21 million Americans have diabetes, but one-third of them don't know it.
Diabetes predisposes a person to heart disease and stroke, blindness, high blood pressure, kidney disease, nervous system damage, dental disease, pregnancy complications and sexual dysfunction.
Source: American Diabetes Association
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