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Two Large, Independent Outcomes Trials Offer New Important Safety Information on Cardiovascular Effects of AVANDIA(R)

SAN FRANCISCO, June 9 /PRNewswire/ -- Two long-term, large-scale and independent studies evaluating cardiovascular (CV) outcomes in people with type 2 diabetes enrolled more than 9,300 patients taking AVANDIA(R) (rosiglitazone maleate) and provide more than 20,000 patient years of additional experience with AVANDIA. The Veterans Affairs Diabetes Trial (VADT), through two separate analyses, concluded that based on results from VADT, there is no evidence to suggest that use of AVANDIA increases the risk for CV mortality and morbidity in patients with type 2 diabetes. A second trial, The Action to Control Cardiovascular Risk in Diabetes (ACCORD), found that AVANDIA was not associated with any increased risk of death. These findings display a safety profile consistent with results from other long-term studies with AVANDIA. These studies were presented during the 68th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, CA.

"The findings on AVANDIA should be reassuring to physicians who prescribe AVANDIA and patients who use AVANDIA for their type 2 diabetes," added R. Paul Aftring, MD, PhD, AVANDIA Clinical Lead at GlaxoSmithKline. "The safety findings on AVANDIA from these two trials add substantial patient experience to the large body of existing evidence on the safety profile of the medication."

Findings from VADT

VADT evaluated whether intense blood sugar control in patients with type 2 diabetes would reduce major CV events. The study continued for 7.5 years. In total, 1,704 patients enrolled in VADT took 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, there was a favorable trend in reducing all CV events, except CV death and inoperable heart disease, among the patients in the intensive arm. There were significantly fewer CV events in the trial than predicted.

In the trial, investigators said that they were "more aggressive" with AVANDIA and other medications in the intensive arm to achieve and maintain tight glycemic targets. The investigators found that in VADT, there were no increased deaths associated with any of the medications used in the trial, including AVANDIA.

Findings from ACCORD

ACCORD, which investigated whether or not intensive blood control would reduce CV events in patients with type 2 diabetes who had either established cardiovascular disease or additional CV risk factors, was presented at a press conference during the ADA Scientific Sessions and published simultaneously in the New England Journal of Medicine. The study had a mean follow-up of 3.5 years. In total, 7,623 patients enrolled in the ACCORD trial took AVANDIA, representing more than 19,200 patient years of experience with the medication.

The investigators found that, as compared with standard therapy, the use of intensive therapy to reach the study's A1C goal for 3.5 years did not significantly reduce major CV events. Although they found an increase in CV deaths among these high-risk patients who were in the intensive arm, the death rates from ACCORD were substantially lower than investigators predicted at the outset of the trial.

In their analysis, the investigators noted that "preliminary nonprespecified exploratory analyses of episodes of severe hypoglycemia after randomization and differences in the use of drugs (including rosiglitazone), weight change, and other factors did not identify an explanation for the mortality finding."

Additionally, an accompanying editorial in the New England Journal of Medicine states, " ... the ACCORD trial investigators concluded that patients in the standard-control group and those in the intensive-control group had similar risks and rates of death, whether or not they were prescribed rosiglitazone."

Other Studies of AVANDIA

In an integrated clinical trial analysis of 42 short-term clinical studies (average duration of 6 months), most of which compared AVANDIA to placebo, showed AVANDIA to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. However, the mortality results reported in the ACCORD and VADT trials are consistent with other long-term trials involving AVANDIA. Data from three other large, long-term prospective randomized controlled clinical trials with AVANDIA (DREAM, ADOPT and interim results from RECORD) included a total of 6,311 patients treated with AVANDIA, representing 21,803 patient years of experience. For these three trials, analyses were performed on major CV endpoints, including total mortality. Results from the analyses of these three other studies show there was no statistically significant difference between AVANDIA and other medications used in the trials with regard to these CV endpoints.

Diabetes and the Role of Improved Blood Glucose 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 attack, stroke, blindness, kidney failure and amputations.

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

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.

Media Contacts: Bernadette King Doug Hochstedler

(215) 751-7709 (646) 244-6600

SOURCE GlaxoSmithKline
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