Landmark Study Published In New England Journal Of Medicine

Main Category: Diabetes
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 10 Jun 2009 - 1:00 PDT

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One of the world's most respected medical journals, the New England Journal of Medicine, is publishing a landmark study this week that explores treatments for people with both Type 2 diabetes and coronary artery disease. The Lang Research and Education Center of New York Hospital Queens was one of the sites that conducted this study.

The study, known as BARI 2D, (Bypass Angioplasty Revascularization Investigation 2 Diabetes) was also presented yesterday in New Orleans at the American Diabetes Association 69th Scientific Sessions -- a national medical conference. The results demonstrated that there is no difference in mortality among patients with type 2 diabetes and stable heart disease who received prompt bypass surgery or angioplasty compared to drug therapy alone. The results also showed that while prompt bypass in patients with more severe heart disease did not lower mortality, it lowered their risk of subsequent major cardiac events.

Phyllis August, M.D., M.P.H., director, Lang Research Center for Research and Education, New York Hospital Queens, served as a co-investigator and co-author of the study. She called the results, "very exciting and good news." "More than 20 million Americans suffer from type 2 diabetes and many of these people also have heart disease. This deadly disease duo is affecting more and more people at increasingly younger ages."

According to Dr. August, the message to patients is a strong one; "you can modify this disease with careful attention to prevention, managing risk factors and by following your doctor's instructions."

"The study's results provide needed guidance about which approaches can best help these patients," said August. They also indicate that when a patient with type 2 diabetes has more severe heart disease it may be better to do bypass surgery early than to wait and simply treat with medication. For patients with milder disease who are candidates for angioplasty, it is appropriate to treat with drug therapy first."

Background

The BARI 2D study began recruiting patients in 2001. The results are based on 2,368 patients with both type 2 diabetes and stable heart disease who were under a physician's care to control their cholesterol and blood pressure. Patients were randomized to receive drug therapy plus undergo prompt revascularization to restore blood flow -- either angioplasty to open blocked arteries or bypass surger -- ?or to receive drug therapy alone. The investigators also looked at which of two diabetes drug treatment strategies resulted in better outcomes -- insulin-providing (increasing the amount of insulin) or insulin-sensitizing (lowering the body's resistance to its own insulin, such as metformin or rosiglitazone). The study was not a comparison between angioplasty and bypass surgery, but rather a comparison between a prompt procedure and medical therapy alone.

The results show that five-year survival rates did not differ significantly between the revascularization group (88.3 percent) and the drug therapy group (87.8 percent). In addition, there was no significant difference in survival between those who received insulin-providing drugs (87.9 percent) and those who received insulin-sensitizing drugs (88.2 percent). However, in the group that received bypass surgery, the rate of all major cardiovascular events (heart attacks, strokes and death) was significantly lower (22.4 percent) compared to those who received drug therapy alone (30.5 percent). This benefit appeared to be greatest in those who underwent bypass and received insulin-sensitizing drugs.

BARI 2D was coordinated by the Epidemiology Data Center at the University of Pittsburgh Graduate School of Public Health and involved 49 clinical sites in the United States and abroad, including The Lang Research and Education Center of New York Hospital Queens, Flushing Queens. Major funders of the study include the National Heart, Lung and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases and GlaxoSmithKline.

Source: New York Hospital Queens