Contact: Ellen Bank
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June 12, 2005
Results of the Epidemiology of Diabetes Intervention and Complications (EDIC) study, being released Sunday, June 12 at the American Diabetes Association scientific meeting in San Diego, show that intensive treatment of diabetes reduces future adverse cardiovascular complications.
The multicenter study, involving 1394 participants, including 56 from South Carolina, Georgia and Florida followed at the Medical University of South Carolina, is an extension of the groundbreaking Diabetes Control and Complications Trial (DCCT) which was closed in 1993 because overwhelming evidence showed that patients with type I diabetes benefit from intensive control of their blood sugar levels. .
The results of DCCT, conducted from 1983 to 1993 by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), showed that keeping blood glucose levels as close to normal as possible slows the onset and progression of eye, kidney and nerve diseases caused by diabetes, said John Colwell, M.D., Ph.D., MUSC professor, former president of the American Diabetes Association and author of the medical text entitled Diabetes, who served as principal investigator for the MUSC site for both the EDIC and DCCT.
One thousand four hundred and forty-one participants were enrolled in DCCT, and each patient was randomized into either an intensive blood sugar control group or a standard treatment group. When the trial results indicated significant decreases in most of the complications from diabetes, it was recommended that all patients should achieve optimal control of their blood sugar levels by either using an insulin pump or very frequent needle stick checks and insulin adjustments
Because the study participants in the initial DCCT trial were young, with a mean age of 27, and the fact that cardiovascular complications usually take a long time to manifest themselves, conclusions concerning the effects of intensive control of blood sugar levels on cardiovascular complications could not be drawn from DCCT.
The follow-up study (EDIC) was started in 1993 to monitor these patients as they aged. At that point, all study participants were put on the intensive control because of the DCCT findings. Some patients had spent a significant amount of time (six to seven years) with their blood glucose levels intensely controlled, during the earlier DCCT phase of the studies. The others were on standard treatment during that time period where their blood sugar levels were not as tightly controlled.
The study results being presented June 12 show for the first time that the reduction of cardiovascular complications of diabetes is an additional benefit of intensive control of blood sugar levels. The intensive treatment during the DCCT phase resulted in a 42 percent reduction in the risk of developing cardiovascular complications. These complications include heart attacks, strokes, angina and the need for procedures to improve the blood supply to the heart, such as coronary artery bypass surgery and the insertion of stents in blocked coronary arteries. The investigators broke down the cardiovascular complications and only looked at what they considered the less subjective end points, which were heart attack and stroke and found that there was a 58 percent risk reduction in these complications in patients who were in the intensive glucose control group during the DCCT phase of the trial.
ěThese are very significant results, and combined with the DCCT results we have a very powerful message for people with diabetes,î said Colwell. ěThe bottom line is that maintaining blood sugar levels as near normal as possible as soon as diabetes is diagnosed is a critical factor in avoiding the serious and sometimes deadly complications associated with diabetes.î
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