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The government announced today it was revamping a big diabetes study because some patients were dying of a treatment designed to help them.
NPR's Richard Knox reports the finding challenges the belief that all patients should try to get their blood sugar as close to those of people without diabetes.
RICHARD KNOX: Millions of patients with diabetes are struggling to get their blood sugars as close to normal as possible. The heart disease benefits are proven with Type 1 diabetes, which begins early in life. But proof has been lacking for Type 2 diabetes, which is far more common.
So the National Institutes of Health launched a big study of aggressive blood sugar control: 10,000 older diabetics at high risk of heart disease got either standard diabetes care or intensive treatment to lower their blood sugar.
The results were the opposite of what everybody expected. The group that got standard treatment had 203 deaths. But the group that got intensive blood-sugar-lowering treatment had 257 deaths over four years. That's 54 more deaths in the group with lower blood sugar.
Confronted with this surprising evidence, officials stopped intensive treatment a year and a half before the study was scheduled to end.
Dr. Elizabeth Nabel is director of the National Heart, Lung and Blood Institute.
Doctor ELIZABETH NABEL (Director, National Heart, Lung and Blood Institute): This shows that if you have Type 2 diabetes and are at a especially high risk for heart disease, very intensive treatments aimed at normalizing blood glucose may be detrimental.
KNOX: This stands conventional wisdom on its head. Dr. James Dove is president of the American Diabetes Association.
Dr. JAMES DOVE (President, American Diabetes Association): For 50 years or more, the common approach to diabetics have been to control blood sugar as well as you can. But the irony is that they tried to drop the blood sugar into the range that the rest of the population is at, trying to making them normal and yet seem to have more deaths based on this study. You need to sort of figure out why that happened.
KNOX: One possible culprit is the drugs the patients were taking to get their blood sugars as low as possible. One of those drugs called Avandia is under somewhat of a cloud. Recent studies suggested patients taking Avandia have a higher risk of heart attacks. But scientists running the study say they found no evidence Avandia or any other drug to lower blood sugar is to blame.
Study researchers promise more analysis soon. Meanwhile, Dr. Steven Nissen of the Cleveland Clinic says diabetics and their doctors may be disoriented as they figure out what to do about a given blood sugar test result. Yesterday, he says if a patient came in with a blood sugar on the high side…
Dr. STEVEN NISSEN (Chairman, Department of Cardiovascular Medicine, Cleveland Clinic): I would generally add another drug.
KNOX: To get the blood sugar lower, but now, he probably won't. Similarly, if a patient's blood sugar tested come back especially low…
Dr. NISSEN: I congratulate the patient on the excellent management of their blood sugar taking a certain amount of credit myself for prescribing the right drugs. Now, I have to ask the question, have I done the wrong thing.
KNOX: Another study coming up this week in the New England Journal of Medicine may just deepen the confusion. Danish researchers say aggressive lowering of blood sugar was linked to dramatically fewer heart attacks and death. But that may be thanks to the drugs those patients also got to lower blood pressure and cholesterol.
For now experts say, older diabetics at risk of heart disease may be able to relax their vigilance about blood sugar just a bit, at least until the next study comes out.
Richard Knox, NPR News.
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