News Release

Data underscores postive safety profile of Avandia

Peer-Reviewed Publication

ACNEM - Australasian College of Nutritional & Environmental Medicine

San Antonio, TX -- Avandia™ [rosiglitazone maleate, SmithKline Beecham] shows no signals of troglitazone-like (Rezulin®, Warner-Lambert) liver toxicity, according to data presented today at the American Diabetes Association (ADA) 60th Scientific Sessions meeting. These findings support the experience of Avandia in the marketplace post-approval, demonstrating that Avandia proves to be a valuable treatment option for patients with type 2 diabetes. "The efficacy and safety profile of Avandia remains consistent with the drug's extensive clinical trial experience and with that of the diabetes population as a whole," said Harold Lebovitz, M.D., Professor of Medicine, SUNY Downstate Medical Center. "Glitazones like Avandia markedly reduce blood sugar levels and may actually slow the progression of type 2 diabetes, which may delay the onset of long-term complications such as cardiovascular, nerve and kidney damage."

Avandia a safe alternative

In this study, researchers examined the incidence of alanine aminotransferase (ALT) levels -- a liver enzyme that indicates disease or drug-related damage if high -- among patients in Avandia clinical trials at the time of Avandia's New Drug Application (NDA) with the U.S. Food and Drug Administration, as compared to the incidence of elevated ALT levels in these patients one year later. Patient years of exposure to Avandia at the first study endpoint were 3600; one year later there were 5000 patient years of exposure.

The study showed that the rate of elevated ALT levels was 0.30 cases per 100 patient years for all patients treated with Avandia. This compares to 0.59 cases per 100 patient years for patients given placebo and 0.73 cases per 100 patient years for patients given a sulfonylurea or metformin, two study comparitors. These are similar to the rates seen one year prior. At the time of this study's conclusion, Avandia had been prescribed to more than 250,000 patients and the clinical trial experience continued to be predictive of the Avandia experience in the marketplace.

Glitazones for the treatment of type 2 diabetes

Glitazones like Avandia help the body respond more effectively to its own insulin. With the new glitazone drugs, instead of only treating the symptoms of diabetes and focusing on controlling blood sugar levels, physicians can treat an underlying cause of type 2 diabetes -- insulin resistance -- one of the key defects of the disease. Unlike many traditional diabetes drugs, which can eventually cause the pancreas to wear out, glitazones help the body's own insulin work more effectively resulting in better blood sugar control. Research shows that glitazones provide sustained improved glycemic control and may prevent disease progression by treating insulin resistance and improving the function of pancreatic beta cells (cells that produce insulin).

Avandia for the treatment of type 2 diabetes

Avandia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes as both monotherapy and in combination with metformin or a sulfonylurea, and is one of a novel class of oral anti-diabetes agents called thiazolidinediones, commonly called glitazones. Since Avandia's approval one year ago (May 25, 1999), more than three million prescriptions have been written, and nearly one million patients have been treated in the United States.

Avandia was well tolerated in clinical trials. Commonly reported side effects were upper respiratory tract infections and headaches which occurred at rates similar to those in placebo treated patients. As observed with other members of this class of drugs, weight gain has also been reported. Additionally, anemia and edema have been reported in patients taking Avandia. Because thiazolidinediones can cause fluid retention, Avandia should be used with caution in patients with edema or in patients at risk for fluid related adverse events. There have been no reported cases of drug-related jaundice or liver failure in any Avandia clinical studies. Nevertheless, periodic monitoring of liver enzymes is recommended.

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Type 2 diabetes in the U.S.

Diabetes, which is the sixth highest cause of death by disease in the United States, strikes an estimated 16 million Americans - 90 to 95 percent of whom have type 2 diabetes. Type 2 diabetes is one of the most costly health problems in America due to its devastating complications. It is a chronic disease characterized by high blood-sugar levels that result from defects in the body's ability to use insulin (insulin resistance) and/or produce insulin. Diabetes is the leading cause of adult blindness, kidney failure and non-traumatic limb loss in the U.S.



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