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Large, Long-Term Veterans Affairs Diabetes Trial (VADT) Reveals Important Cardiovascular Safety News on AVANDIA(R)
Date:6/8/2008

on (80%), lipid abnormalities (50%) and the majority were obese. Due to this high-risk patient population, the investigators predicted that there would be 650-700 CV events among the patients. However, there were significantly fewer CV events in the trial - 263 in the standard group and 231 in the intensive group.

Use of AVANDIA in VADT

AVANDIA was used along with other treatment options in the intensive arm to achieve tight glycemic goals. AVANDIA was the most commonly prescribed drug in the first year of the study - 85% and 78% in the intensive and standard arms, respectively. By the third year, use of AVANDIA decreased to 72% in the intensive arm and to 62% in the standard arm. The investigators noted that some of the reasons for this decrease relate to the known side effects of weight gain and edema associated with AVANDIA. There were no increased deaths in the study that were associated with AVANDIA.

VADT Study Design

VADT is a prospective, two-arm, randomized clinical trial designed to evaluate whether intensification of glucose control can reduce major CV events in patients with type 2 diabetes. A total of 1,791 mostly male veterans aged 41 and older with type 2 diabetes who were no longer responding to a maximum dose of at least one oral antidiabetic agent and/or daily insulin injections were enrolled over two years and followed up for a period of five to seven years, with clinician visits scheduled every 1.5 months; and were randomized to receive either intensive glycemic therapy (HbA1c less than 7%) or standard glycemic therapy (HbA1c = 8-9%).

Diabetes and the Role of Improved Blood Sugar Control

More than 19 million Americans have type 2 diabetes - a chronic, progressive and serious disease that occurs either when the body does not produce enough insulin or when the body does not respond properly to its natural insulin.

Improving blood sugar control in people with type 2 diabetes can help reduce the risk of
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SOURCE GlaxoSmithKline
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