PRINTType 2 troubles
Diabetes study produces questions
Rebecca Bierig
February 28, 2008 | 3:49 p.m. CST
Working to lower blood sugar to healthier levels is a way of life for most diabetics. Regular exercise, calorie counting, pills or daily insulin shots become necessary habits to get blood glucose down to a target range.
Understandably then, Type 2 diabetics, who are an average of 62 years old, were surprised when the National Heart, Lung and Blood Institute announced the suspension of an ongoing clinical trial dealing with diabetes and cardiovascular disease earlier this month. High risk patients — Type 2 diabetics with a threat of heart attack or stroke — had an increased risk of death if they used intense measures to try to lower blood sugar levels.
Non-diabetics naturally maintain blood sugars in a tight range, says Dr. Garry Tobin, director of the diabetes center at Washington University and Barnes Jewish Hospital in St. Louis. The ability to lower diabetics’ blood sugars to that range is difficult and requires a lot of effort on the part of the physician and the patient. Multiple drugs, including a combination of short- and long-acting insulin, are needed.
The NHLBI stopped the sub-study within the trial 18 months early after reviewing the available data. Over a four-year period, 14 out of every 1,000 patients died while undergoing intensive treatment to lower blood sugar levels to equal those without diabetes. In comparison, 11 patients in every 1,000 died while undergoing standard, less-intensive treatment.
Tobin says the study won’t overrule what’s been working for diabetes management. “It doesn’t say that the target (blood sugar levels) are wrong, but be careful how you achieve it,” Tobin says.
He adds that it’s important to remember that the trial studied a high-risk population, and there is a risk to lowering blood sugar levels — hypoglycemia. Hypoglycemia occurs when blood sugar levels drop too low to provide enough energy for the body’s activities. The condition can result in a lack of fuel for the brain, which in severe cases can have multiple negative repercussions, including seizures, dizziness or confusion. Tobin says he suspects patients undergoing aggressive treatment to lower blood sugar received combinations of multiple drugs, some of which could be associated with hypoglycemia.
Dr. Jeffery Frey, a Columbia specialist in internal medicine and geriatrics, says the results of the study make sense when you consider a patient who just had a heart attack, but the results don’t apply to most diabetics. “Low blood sugar, aggressive treatment, can be bad for the heart,” he says. “But (the trial) can’t become an excuse not to care for diabetes.”
Although news of the study has garnered attention from mainstream media, including The New York Times, Colleen Fogarty, a communications specialist for the American Diabetes Association, says its call center has only received a handful of calls regarding the study.
Doctors expect questions from curious patients, but with the exception of a few physicians, most local doctors weren’t ready to comment on the ramifications of the trial. Because the trial studied particularly aggressive blood sugar-lowering methods, physicians have some time before they need to react, which suggests the study won’t drastically change diabetes treatment — at least not yet.
The American Diabetes Association has advised patients to stick with their current treatment programs, citing that long-established research has demonstrated the importance of glucose control.
The trial is scheduled to continue until June 2009, and participants who were undergoing intensive treatment to lower blood glucose levels will now receive standard treatment. Diabetics won’t have a good idea of what accounted for the surprising results until the study ends and official results are released.
