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-- DiabetesAmerica’s™ response to the publicity surrounding conflicting study results concerning intensive blood sugar control in type 2 diabetes and the risk for cardiovascular disease.
February 14, 2008
By now, you may have heard or read about the ACCORD (Action to Control Cardiovascular Risk in Diabetes) Study. Briefly, it is a study of over 10, 000 patients with type 2 diabetes and known heart disease, or at least 2 other risk factors for heart disease (i.e. obesity, smoking, high blood pressure, and high cholesterol.) It evaluated the difference in cardiovascular outcomes between people with diabetes who were treated with “standard care” blood sugar lowering and those treated with “intensive” blood sugar lowering. On February 6, 2008, the intensive treatment arm was halted when a preliminary review of the data suggested those receiving “intensive” blood sugar lowering had a higher risk of death from heart attack than those randomized to the “standard care” group. Arms of the study examining the effect of standard vs. aggressive treatment of blood pressure and cholesterol were continued.
The ACCORD Study
The ACCORD study was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and received additional support from the National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK). The ACCORD trial began 2/2003 and is to conclude in June 2009. Patients enrolled are an average age of 62, have a history of type 2 diabetes for an average of 10 years, and the average A1C upon entering the study was 8.2%.
The intensive blood sugar control group aimed at an A1C of < 6.0%, while the standard group aimed for an A1C of 7-7.9%. After being randomized to one of the blood sugar control groups, the patients were further divided into standard vs. aggressive treatment groups for high cholesterol and blood pressure as was appropriate. The aggressive blood pressure control group had their blood pressure lowered to < 120, as opposed to < 140; the aggressive cholesterol treatment group was given a “statin” to reduce LDL to < 100 (HMG Co-A reductase inhibitor) and a “fibrate” to further lower triglycerides and raise HDL, while the standard group received only the “statin.”
The actual median A1C achieved in the intensive group was 6.4%, and median achieved in the standard group was 7.5%. Over 4 years, the intensive treatment group had 14 deaths/1000 participants/year, whereas the standard group had 11 deaths/1000 participants/year. The standard group had 203 deaths overall, vs. 257 in the intensive group. There were 10% fewer nonfatal heart attacks in the intensive group than in the standard treatment group, but if a heart attack did occur; it was more likely to be fatal. There was also an increased risk of sudden death in the intensive group. The deaths do not appear to be due to any particular drug combination. The particular factors involved in the higher rate of death have not been identified.
It must be pointed out that both rates of death were lower than that normally seen in this high risk group (previous data put risk of death as 50 deaths/1000 individuals/year or 5% per year).
Other Studies
In contrast, the ADVANCE Study, an international study involving 11,140 high-risk patients with type 2 diabetes which is just concluding, announced that their study provides no evidence of an increased risk of death among those patients receiving intensive treatment to lower blood sugar. The ADVANCE interim results were based on more than twice as much data and similar levels of glucose control as in ACCORD. The ADVANCE trial was five years in duration. The results of a third trial, the VA Diabetes Trial, which also looks at the relationship between intensive blood sugar control and cardiovascular outcomes in type 2 diabetes, will also be available later this year.
The DiabetesAmerica™ Position
We at DiabetesAmerica™ agree with the decision to halt the arm of the ACCORD study examining intensive control for safety concerns, until a full statistical analysis of the data can be performed. We also agree that no one should change their diabetes treatment without first consulting with their doctor.
The ACCORD study does not apply to patients that are newly diagnosed with diabetes or have had diabetes for a short duration. It can only be said to apply to the particular high risk group already defined. It also does not apply to patients with Type 1 diabetes. It is even more interesting that studies suggest tight blood sugar control does have favorable effects on cardiovascular disease development in those with Type 1 diabetes.
We agree with the sponsors of the study and the ADA (American Diabetes Association) that, in general, an A1C of < 7% is desirable. However, the authors of the study do suggest that, in patients with diabetes who have similar characteristics to those in the study (average age of 62 and diabetes for at least 10 years and high risk heart disease with 2 or more risk factors), less stringent blood sugar control may be better. We recommend that people with type 2 diabetes who have existing CVD or multiple CVD risk factors and have questions about the findings should consult with their DiabetesAmerica™ care team about their treatment goals. We at Diabetes America™ have always stressed the individualization of these goals. We look forward to the time later in 2008 when the data from ACCORD, ADVANCE and the VA Diabetes Trial, are all available for examination. We will keep you informed of any new recommendations.
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