|
February 10, 2008
To our Berrie Center Patients and Families and Others with Questions about the Recently Announced Change in the ACCORD Trial:
As many of you have heard, the National Institutes of Health (NIH) recently stopped the intensive blood sugar treatment component of the large multi-center clinical trial studying prevention of cardiovascular disease in type 2 diabetes, the "Action to Control Cardiovascular Risk in Diabetes" (ACCORD) Trial. The Berrie Center is one of the study sites for this critically important diabetes trial. We are writing to summarize the safety reasons behind stopping the glucose component of the ACCORD Trial and to answer questions that have been asked by many of our patients.
The ACCORD Trial includes 10,251 older subjects with long-standing type 2 diabetes and a history of a prior heart attack or stroke (prior cardiovascular disease) and/or multiple risk factors for cardiovascular disease. Subjects were randomly assigned to have their blood sugars lowered to the non-diabetic range (A1c <6%) or to modestly aggressive glucose-lowering therapy (A1c 7-7.9%). The tight/intensive glucose component of the study was stopped when it was found that 20% more subjects died in this group compared to the group with more modest glucose control. Study participants who had been randomized to the intensive blood glucose lowering treatment will now receive the less-intensive blood sugar lowering treatment. There was some extremely good news that got overlooked in the recent press coverage: the death rate was decreased overall in the study to an average of 1.5% per year from the expected 4-5% per year by the combined therapy to lower glucose, blood pressure and blood lipids that was provided to these high-risk patients as part of the ACCORD Trial.
The ACCORD Trial will not be complete until 2009 and much more data analysis needs to be done in order to understand why patients in the intense glucose treatment group had a higher risk of death than the others whose glucoses were treated less aggressively. Diabetes management must be individualized. We encourage all patients to speak to their physicians about whether these new ACCORD data should lead to a change in diabetes management.
Q&A
1. Do these new ACCORD Trial safety data have relevance to patients with type 1 diabetes
No.
The ACCORD Trial results have the most immediate relevance to older patients with long-standing type 2 diabetes and established cardiovascular disease. Many studies in type 1 diabetes, such as the DCCT and the EDIC Trials, have demonstrated that strict glucose control prevents and delays diabetic complications such as retinopathy and heart disease. The ACCORD data are unlikely to lead to any changes in diabetes management in patients with type 1 diabetes.
2. Do these new ACCORD Trial safety data have relevance to younger patients with new-onset type 2 diabetes or those without vascular complications?
No.
Again, diabetes management must be individualized. In most cases, controlling glucose toward normal will continue to be the goal in many patients. The American Diabetes Association (ADA) recommends that patients with diabetes should target an A1c <7% unless there is a reason for a higher A1c. Older patients with type 2 diabetes at high-risk for cardiovascular disease should talk to their physicians about whether these new ACCORD safety data should lead to a different A1c goal.
3. Why might patients with type 2 diabetes and cardiovascular disease have had a higher risk of death with more aggressive glucose control than those with more modest glucose control?
We do not yet have enough information to know the answer to this question yet. It is possible that the combinations of medications needed to try to normalize blood sugar led to increased side effects and contributed to the higher death rate. Preliminary data indicate that no one medication, such as rosiglitazone, was a major factor, nor was hypoglycemia. It is also important to point out that the less intense glucose control provided to the “conventionally” treated group was still rather intense with an A1c target of 7-7.9%. These data do not suggest that patients with type 2 diabetes should ignore good glucose control as treatment for their diabetes.
4. Why was the overall death rate lowered by participation in the ACCORD Trial compared to the expected rate in this high-risk group?
Data from the ACCORD Trial and from the recently reported Steno-2 Trial have confirmed that a multi-pronged attack aimed at all of the components of the metabolic syndrome that often accompany type 2 diabetes is very beneficial in reducing mortality. Patients with type 2 diabetes should also work with their health care team to treat the high blood pressure and high cholesterol and triglycerides that may also be present. Patients with type 2 diabetes should also discuss aspirin therapy with their doctor as another strategy to prevent cardiovascular disease.
5. The ACCORD Trial focused on secondary prevention in patients who already had complications of diabetes. What should be done to prevent diabetes complications or to prevent diabetes?
Diet and exercise!
The ACCORD Trial included very high-risk patients, many whom had already had a heart attack or a stroke or other diabetes vascular complications. Many studies have shown that increasing activity and eating a healthy diet can go a long way toward helping to prevent diabetes complications, and, in many patients, can help prevent diabetes in the first place.
6. Where can I get more information?
Here is a link to the NIH for their press release about the ACCORD changes:
http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=2551
Here is a link to the ADA for their statement about ACCORD and Q&A:
http://www.diabetes.org/for-media/pr-ada-statement-related-to-accord-trail-announcement-020608.jsp
http://www.diabetes.org/for-media/pr-accord-trail-QA-020608.jsp#6
Here is a link to an interview on NPR with Dr. Goland about the
ACCORD Trial http://www.wnyc.org/news/articles/93562
Contact us at 212-851-5492 or diabetes@columbia.edu if you have additional questions.
Hope this information was helpful.
Sincerely, The Diabetes Team at the Berrie Cente
|
