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

Primary Findings from VADT on Benefit of Intensive Blood Sugar Control Are Not Statistically Significant but Show Favorable Trend in Reducing Most CV

Events

SAN FRANCISCO, June 8 /PRNewswire/ -- Findings from the Veterans Affairs Diabetes Trial (VADT), a large, long-term and independent cardiovascular (CV) outcomes study in high-risk diabetes patients were released today at the 68th Scientific Sessions of the American Diabetes Association (ADA). According to news announced by the ADA, AVANDIA(R) (rosiglitazone maleate) was used in a majority of patients in the study and was not associated with increased deaths. These safety data are consistent with results from other long-term studies with AVANDIA. The primary result of VADT did not show that intensive blood sugar control (HbA1c levels below 7%) had a statistically significant effect on reducing major CV events associated with diabetes. However, it was found that there was a favorable trend in reducing all CV events, except CV death, among the patients in the intensive arm.

"Given the size and duration of this trial, the data on AVANDIA offer important safety information to physicians treating patients with type 2 diabetes," said Farhad Zangeneh, MD, FACP, FACE, assistant clinical professor of medicine at the George Washington University in Washington, DC and medical director of the Endocrine, Diabetes & Osteoporosis Clinic in Sterling, VA.

Dr. Zangeneh added, "While the VADT did not meet its primary endpoint, it is critical that these results do not detract from what we already know about the benefits of long-term blood sugar control on other serious and potentially life-threatening complications of diabetes, such as kidney failure, blindness and amputation."

In VADT, the patient population was considered at higher risk for CV disease since more than 40% had prior CV events. Further, trial participants had other risk factors, including hypertension (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 diabetes-related complications, which include heart disease, stroke, eye damage, kidney failure and foot problems that lead to amputations. An epidemiological analysis from the United Kingdom Prospective Diabetes Study (UKPDS) showed that every one percent drop in HbA1c is associated with a significant reduction in risk of death related to diabetes by 21 percent, heart attack by 14 percent and diabetes-related microvascular complications by 37 percent.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com.

Important Safety Information for AVANDIA (R) (rosiglitazone maleate)

AVANDIA, along with diet and exercise, helps improve blood sugar control in patients with type 2 diabetes.

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin. Taking AVANDIA with insulin or with nitrates is not recommended.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking.

If you take AVANDIA, tell your doctor right away if you:

- Have swollen legs or ankles, a rapid increase in weight or difficulty

breathing, or unusual tiredness

- Experience changes in vision

- Become pregnant

Review your medical history and tell your doctor if you:

- Have heart failure or other heart problems

- Have liver problems or liver disease

- Are pregnant or are nursing

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy.

More fractures have been observed in women taking AVANDIA.

For more information about AVANDIA, please see Patient Information. For further information on AVANDIA, please see full Prescribing Information.


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SOURCE GlaxoSmithKline
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