Appropriate Glycemic Control Contributes To Reducing The Risk Of Macrovascular Diseases In Patients With Diabetes

Main Category: Diabetes
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 01 Oct 2007 - 0:00 PST

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A retrospective analysis from the Integrated Health Care Information System database (IHCIS) of 69,418 patients with diabetes showed that elevated A1C levels were statistically significantly associated with higher risk of macrovascular events. The new findings presented at the European Association for the Study of Diabetes' 43rd Annual Meeting, add to the growing debate in the diabetes community about glycemic control and the cardiovascular risks associated with diabetes.

The Hemoglobin A1C test measures average blood glucose levels over a two to three month period. Compared to the group of patients with A1C<6% the hazard risk for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) surgery or stroke was higher in patients with A1C between 7 and 9% by 8% (p<0.01) and 15% (p<0.001) in the A1C≥9% group.

Patients in the data base were 54% male, with a mean age of 57 years, an index A1C 7.6% and a mean follow up from A1C index of 27 months. The patients were stratified into 4 groups based on index A1C: <6%, 6-7%, 7-9%, and ≥9%. Survival analysis was conducted to examine the first occurrence of acute myocardial infarction, CABG surgery or stroke after index A1C control with patients being censored at the end of their health plan enrollment.

Heart disease and stroke account for approximately 65% of deaths in people with diabetes. This finding demonstrating a high incidence of macrovascular events in diabetic patients with A1C >7% is important because appropriate glycemic control may contribute to reducing the risks of macrovascular diseases in this patients population.

"Elevated A1C level is a significant risk factor for myocardial infarction, coronary artery bypass graft surgery and stroke in patients with diabetes. Early intervention with intensive diabetes treatment may reduce these macrovascular risks," stated Pr. J. M. Foody, Internal Medicine/Section of Cardiology, Yale University School of Medicine, New Haven, United States.

About guidelines

Being the most potent mean of lowering blood sugar levels (1), insulin should be the appropriate treatment to improve cardiovascular outcomes in at-risk patients elevated A1C directly for T1 patients and in spite of appropriate diet and oral antidiabetic treatment for T2 patients.

About Lantus® (insulin glargine [rDNA origin])

Lantus® is the only 24 hour peakless insulin approved exclusively for use once a day. Most insulins have a "peak of action", which refers to the time at which insulin reaches its maximum effect in the body. With Lantus®, the insulin is released into the bloodstream at a relatively constant rate throughout the day and night; therefore it has no pronounced peak.

In type 2 diabetes, the final mean A1C on Lantus® ranged from 6.9% to 7.2% in 7 studies where aggressive titration was performed and strict monitoring was used (2 - 8).

A major clinical trial known as ORIGIN (Outcome Reduction with Initial Glargine INtervention) is currently examining the effects of the long-acting insulin Lantus® (insulin glargine [rDNA origin] injection) on cardiovascular outcomes in more than12,000 patients, 50 years of age or older with at least one cardiovascular disease risk factor and pre-diabetes or early type 2 diabetes. ORIGIN is a 5-year, randomized, open-label, multicenter, 2 x 2 factorial design trial. Results are anticipated in 2010.

About Diabetes

Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin the hormone needed to convert glucose (sugar) into energy. More than 230 million people worldwide are living with the disease. This number is expected to rise to a staggering 350 million within 20 years (9). It is estimated more than 20 million Americans have diabetes, including an estimated 6.2 million who remain undiagnosed (10). At the same time, approximately half of those diagnosed are not achieving the general blood sugar control standard of A1C <7% recommended by the American Diabetes Association (ADA)(11). The A1C test measures average blood glucose levels over a two- to three-month period.

References

1 : Nathan et al. "Management of hyperglycemia in type 2 diabete: a consensus algorithm for the initiation and adjustment of therapy". Diabetologia 2006; 49:1711-1721

2 : Riddle M.et al. Diabetes Care 2003; 26: 3080 3086.

3 : Standl E. et al. Horm Metab Res 2006; 38: 172 177.

4 : Rosenstock J. et al. Diabetes Care 2006; 29: 554 559.

5 : Janka H. et al. Diabetes Care 2005; 28: 254 259.

6 : Yki-Jarvinen H. et al. Diabetologia 2006; 49:442 451.

7 : Gerstein H, et al. Diabetic Medicine 2006; 23:736 742.

8 : Yki-Jarvinen H, et al. Diabetes Care 2007; 30:1364 1369.

9 : World Health Organization. Unite for Diabetes Campaign key messages.

10 : Centers for Disease Control. National Diabetes Fact Sheet 2005.

11 : Resnick HE. Achievement of American Diabetes Association Clinical Practice Recommendations Among U.S. Adults With Diabetes, 1999 2002. Diabetes Care. 2006 Mar 29:531 537.

About Sanofi Aventis

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