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University of Pittsburgh’s Graduate School of Public Health Receives $1.5 Million Grant for BARI 2D Study

PITTSBURGH, October 23, 2001 — The University of Pittsburgh Graduate School of Public Health (GSPH) has received a $1.5 million grant from Bristol-Myers Squibb for the Bypass Angioplasty Revascularization Investigation 2D (BARI 2D) study.

The study will determine the best way to treat patients who have early coronary artery disease (CAD) and type 2 diabetes. CAD is the number one killer of people with type 2 diabetes.

The study, which is being coordinated by GSPH, previously received grants of more than $52.2 million from the National Heart, Lung and Blood Institute; $4.2 million from the National Institute of Diabetes and Digestive & Kidney Diseases; and $15 million from GlaxoSmithKline.

BARI 2D is comparing the effectiveness of various therapeutic regimens in reducing the number of deaths from CAD among type 2 diabetics. Investigators aim to determine whether aggressive drug therapy is more effective alone or in combination with surgery in reducing mortality in this population. In type 2 diabetes, the body is unable to properly use insulin – a hormone needed to metabolize simple sugars. Such insulin resistance is a major risk factor for cardiovascular disease.

With the help of 2,800 volunteer participants, the study will answer two questions that are critical to type 2 diabetic patients with stable coronary artery disease: Under what circumstances is it best to undergo revascularization in addition to drug therapy? and, Which method of drug therapy is best at controlling glucose?

BARI 2D participants at each clinical site are randomly assigned to either aggressive drug therapy alone or to a combination treatment consisting of drug therapy and revascularization, either bypass surgery or angioplasty.

Participants are randomized further to either insulin provision or insulin sensitization to determine which method of glucose control is more effective. Insulin provision, which for decades has been the standard of care for type 2 diabetic patients, involves augmenting one’s insulin store through daily injections or oral agents that stimulate insulin production. This method will serve as the control against which a newer strategy – insulin sensitization – will be tested. Insulin sensitization uses drugs such as metformin or rosiglitazone to lessen the body’s resistance to insulin, thus allowing the body to properly use the insulin it normally produces.

All patients will be followed for a minimum of five years to assess mortality, heart attack, stroke and other clinical events, angina, quality of life and cost of treatment. They will be on strict risk-factor management to control obesity, lipids and high blood pressure.

In addition to the University of Pittsburgh, sites for the BARI 2D study include academic medical centers across the United States and Canada.

For more information about the BARI 2D trial and local clinical sites, access http://www.edc.gsph.pitt.edu/.

Established in 1948, the GSPH at the University of Pittsburgh is world-renowned for contributions that have influenced public health practices and medical care for millions of people. It is the only fully accredited school of public health in the Commonwealth of Pennsylvania and is one of the top-ranked schools of public health in the United States. It is one of eight schools across the country to be designated a Public Health Training Center by the U.S. Department of Health and Human Services.

For more information about the GSPH, access the school’s website at http://www.publichealth.pitt.edu.

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