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| |  ENDO 2000: Avandia (Rosiglitazone Maleate) Effective In Long-Term Blood Sugar Control In Type 2 Diabetes TORONTO, ON -- June 21, 2000 -- Two-year data presented at the Annual Meeting of the Endocrine Society (ENDO 2000), support the use of SmithKline Beecham's Avandia® (rosiglitazone maleate) as first-line therapy for type 2 diabetes patients. Avandia, an oral anti-diabetes drug that treats a major underlying cause of the disease - insulin resistance - was shown to be more effective than glyburide, a sulfonylurea, in improving and sustaining blood sugar control. Long-term blood sugar control may reduce the risk of complications associated with type 2 diabetes. "For decades, therapy with a sulfonylurea has been standard first-line treatment for people with type 2 diabetes," said Alan Salzman, M.D., Ph.D., Director, Diabetes and Metabolism, Clinical Research, Development and Medical Affairs, North America, SmithKline Beecham. "This research shows that the efficacy of sulfonylureas may decline over time, whereas Avandia provides sustained blood sugar control." Treatment for type 2 diabetes with sulfonylureas, while initially effective, may fail to provide long-term blood sugar control in many patients. Sulfonylureas work by increasing insulin output by the pancreas, but may eventually cease to control blood sugar levels as pancreatic exhaustion leads to decreased insulin output and an elevation of blood sugar levels. In the study, 203 patients with type 2 diabetes were randomly assigned to receive either Avandia or glyburide as monotherapy. At the start of the study, all patients had poor blood sugar control, with elevated levels of fasting blood glucose (FPG). Patients' HbA1C levels, a marker of long-term blood sugar control, were also elevated. Improvements in glycemic control were measured based on decreases in FPG and HbA1C. At 100 weeks, the researchers found that Avandia provided long-term, sustained improvements in blood sugar control relative to glyburide. Avandia produced a gradual, sustained reduction in HbA1C levels, whereas the glyburide response was more variable. Also, FPG levels were maintained up to week 100 in the group treated with Avandia, and were lower than the glyburide group at 100 weeks of therapy. Additionally, the researchers noticed that improvements in blood sugar control seen with Avandia were associated with an increase in high-density lipoproteins (HDL)-cholesterol, and an initial increase in low-density lipoproteins (LDL)-cholesterol, returning to baseline overtime. HDL-cholesterol is considered to protect the heart from disease, while LDL-cholesterol is considered to promote heart disease. "These findings further support the ability of Avandia to control blood sugar levels and maintain these levels in the long-term," added Dr. Salzman. "We have not observed this property in any other traditional treatments for type 2 diabetes." Avandia is 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 antidiabetes agents called thiazolidinediones, commonly called glitazones. Avandia was generally well tolerated in clinical trials. Commonly reported side effects were upper respiratory tract infections and headaches. 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 was no signal of drug-related jaundice or liver failure in any Avandia clinical studies. Worldwide post marketing experience is consistent with clinical trial findings. Nevertheless, periodic monitoring of liver enzymes is recommended. 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 the leading cause of adult blindness, kidney failure and non-traumatic limb loss in the United States. Diabetes is a chronic disease characterized by high blood-sugar levels that result from defects in the body's ability to use and/or produce insulin. There are two main types of diabetes: type 1 and type 2. People with type 1 diabetes are usually diagnosed when they are children or young adults. In type 1 diabetes, the pancreas makes little or no insulin, so patients must test their blood sugar and inject insulin every day. In type 2 diabetes, the pancreas continues to produce insulin, but the body inefficiently uses the insulin. Many patients with type 2 diabetes will eventually require insulin injections. Related Links: Avandia (rosiglitazone maleate) and SmithKline Beecham.
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