Federal researchers who tried to reduce heart attacks among diabetics by driving their blood sugar to low levels found that more patients were dying instead. The finding, announced yesterday, prompted officials to halt part of a major study of diabetes and heart disease.
Researchers said they don't know what caused the spike in deaths but said it can't be blamed on Avandia - a diabetes medication linked last year to an increased risk of heart attacks - even though some volunteers were taking the drug.
"Clearly we did not anticipate the findings," said Dr. Elizabeth G. Nabel, director of the National Heart, Lung and Blood Institute of the National Institutes of Health, which is running the clinical trial.
FOR THE RECORD - A Page 1 article in Thursday's editions of The Sun about unexpected results in a national diabetes study misspelled the name of Dr. Sherita H. Golden, an endocrinologist at the Johns Hopkins School of Medicine. Also, it should have included a more complete explanation of the index, called glycosylated hemoglobin, that is used to measure glucose control. Specifically, it is the percentage of red blood cells that have a sugar attached to them.
The Sun regrets the errors.
The troubling results call into question the popular theory that radically lowering blood sugar levels in patients with Type 2 diabetes could prevent heart attacks and stroke.
"We have to be careful, because more is not always better," said Dr. W. Douglas Weaver, president-elect of the American College of Cardiology and head of cardiology at the Henry Ford Health System in Detroit. "The importance of this study is: Sometimes the unintended happens. In this case, lowering blood sugar to normal levels had poor outcomes."
The ACCORD study (Action to Control Cardiovascular Risk in Diabetes) enrolled 10,251 participants at 77 sites in the U.S. and Canada, including the Baltimore Veterans Affairs Medical Center.
Of these, 257 in the intensive therapy group died over the course of four years, compared with 203 in the standard treatment group.
Using modified diet, exercise and glucose-lowering medication, the goal for the standard treatment group was to reduce blood sugar levels to a point known to be safer for diabetics - but still higher than normal.
In the intensive therapy group, doctors were more aggressive, aiming to drive blood sugar levels down to those found in nondiabetics. They saw those patients more often, had them test their blood sugar more frequently and put them on more medications, researchers said.
Overall, the death rate in both groups was well below normal for Type 2 diabetics - probably the result of the extra care and monitoring that ACCORD patients received.
The study found some beneficial effects from aggressive blood sugar lowering. For example, there were 10 percent fewer nonfatal cardiovascular events - such as heart attacks - in the intensive group, as opposed to the standard treatment group.
