The startling findings of a major federal study on the effects of lowering blood sugar are unlikely to change the way most people with Type 2 diabetes manage their illness, doctors said Thursday.
The study, announced Wednesday, showed that an intensive program to lower blood sugar actually increased risk of death. The findings were so surprising that the study was stopped early, and they seemed to undercut the accepted wisdom that people with diabetes should do everything possible to get their blood sugar down to normal.
But the methods used in the study, called Accord (for Action to Control Cardiovascular Risk in Diabetes), bear little resemblance to the techniques most doctors and patients use to manage blood sugar levels. And the patients in the study were typically far sicker than many people with diabetes today.
“The intensity of what we did is done virtually nowhere on the planet,” said Dr. John Buse, vice chairman of the study’s steering committee and the president of medicine and science at the American Diabetes Association. “It’s far beyond what’s common in clinical practice.” Dr. Buse called the study’s regimen to lower blood sugar a “brutal program.”
Still, doctors are likely to reconsider their emphasis on lowering blood sugar at all costs, because it is becoming clear that other factors influence the overall health of patients with diabetes.
The New England Journal of Medicine published a study this week showing that a three-pronged approach of managing sugar, blood pressure and cholesterol — combined with low doses of aspirin — prolonged the lives of people with diabetes. The patients who did best in that study did not reach the nearly normal sugar levels that were the aim of the Accord study. Instead, their levels were just slightly higher than normal.
In the Accord study, the group of patients who were randomly assigned to lower their blood sugar levels to nearly normal had 54 more deaths than the group whose levels were less rigidly controlled. The patients were in the study for an average of four years when investigators stopped the intense regimen and put all of them on the less intense one.
“When we look at mortality in patients with Type 2 diabetes, it’s not only the blood sugar,” said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in the Bronx. “What the study shows is that just lowering blood sugar is not protecting you from dying sooner. Blood sugar is important, but so is blood pressure and cholesterol.”
Patients with newly diagnosed diabetes still appear to have much to gain by keeping their blood sugar levels as close to normal as possible through healthful eating and exercise. But patients who have had a heart attack and have other risk factors need not feel guilty if they cannot get their blood sugar to normal levels, Dr. Buse said.
“The most important thing is get your blood pressure controlled, cholesterol controlled, and do a reasonable job on your diabetes, but don’t go wild,” he said. “We are backing away from notion that we always have to push, push, push to get blood sugar lower.”
Today, many patients with diabetes take two or three drugs to manage their blood sugar levels. In the Accord study, many patients took multiple drugs and insulin shots, adhered to strict diets and regularly met with counselors and doctors who monitored them. No single drug treatment was prescribed; doctors used whatever combination of various treatments that appeared to work best in each patients.
The researchers still have to sift through the data on those who died to find out whether there was any pattern that might help explain why patients in the intense treatment group fared worse. It may be that they were simply sicker to begin with. It may have been the number of drugs they used or the pace at which their blood sugar dropped.
Dr. Buse said one little-discussed issue was the sheer stress of the treatment program itself. He noted that the program demanded a lot of effort from patients but that it was still exceedingly difficult for any of them to achieve the blood sugar levels that had been set for them. Many patients with diabetes feel stressed when they fail to meet blood sugar goals set by their doctors.
“At some level I just wonder if some of them were just overwhelmed by this psychologically,” Dr. Buse said. “Could it be the stress of ‘I’m trying so hard, but I can’t get it done’?”
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