Appropriate Glycemic Control Contributes to Reducing the Risk of Macrovascular Diseases in Patients with DiabetesPARIS, Sept. 19, 2007-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 followup
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
“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.
Being the most potent mean of lowering blood sugar levels1, 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.
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 years9. It is estimated more
than 20 million Americans have diabetes, including an estimated 6.2 million who remain undiagnosed10. 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.
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe.
Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal
medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not historical facts. These statements include product
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Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31,
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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
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9. World Health Organization. Unite for Diabetes Campaign key messages. Available at:
http://www.unitefordiabetes.org/youth/files/UNR_key_messages_20060828.pdf. Accessed March 28, 2007
10. Centers for Disease Control. National Diabetes Fact Sheet 2005. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf. Accessed on November 28, 2006.
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
Posted: September 2007