First glitazone studied in long-term trial to evaluate prevention of disease complications through intensive therapy
Philadelphia, PA, June 9, 2000 -- SmithKline Beecham today announced that the company's antidiabetes drug Avandia® [rosiglitazone maleate] will be a key treatment in a nationwide, 1,700-person study conducted by the Department of Veterans Affairs (VA) to determine the impact of intensive drug therapy on preventing the life-threatening complications associated with type 2 diabetes. This is the first study specifically designed to evaluate the ability of intensive combination therapy to prevent diabetes-related complications, such as heart attack, stroke, limb amputation, kidney failure and blindness. Avandia is one of a novel class of oral antidiabetes agents, commonly called glitazones, which treat the symptoms of type 2 diabetes by directly targeting insulin resistance -- an underlying cause of the disease.
"We are pleased the Department of Veterans Affairs recognizes the need to target insulin resistance with a glitazone to control blood sugar and prevent serious disease complications and will include Avandia as part of this important clinical trial," said David Krause, M.D.,Vice President and Director, Metabolism and Pulmonary Therapeutic Unit, SmithKline Beecham.
Department of Veterans Affairs (VA) committed to landmark Study
One quarter of the patients treated by the VA has type 2 diabetes. Diabetes is one of the most costly heath problems in America, due to its devastating consequences. Heart disease is the cause of 75 percent of diabetes-related deaths, and people with diabetes are two to four times more likely to suffer from a heart attack or stroke. In addition, diabetes is the leading cause of kidney failure and blindness. The risk of leg amputation is up to 40 times greater for a person with diabetes.
"We are excited to be conducting this study and look forward to using the findings to help us make treatment decisions for patients in our hospitals," said study co-chairman William Duckworth, M.D., of the Pheonix VA Medical Center, of his work with study co-chairman Carlos Abraira, M.D. of the Miami VA Medical Center.
The VA study is the first prospective study to evaluate the outcome and cost-effectiveness of intensive therapy versus standard therapy to prevent diabetes-related complications. Recruitment for the study will take approximately two years. Patients will be followed for five years to assess rates of heart attack, heart failure, stroke, amputation and surgery for coronary artery or peripheral vascular disease.
The study, which is set to begin in July 2000, will involve 1,700 patients in 20 centers across the United States. Patients will be randomized to receive either standard or intensive therapy, following guidelines established by the American Diabetes Association (ADA). Patients in the standard therapy group will receive either metformin or glimepiride, a drug of the sulfonylurea class, adding Avandia, followed by insulin in steps as necessary. Patients in the intensive therapy group will receive the same treatments, but in higher doses. Patients who are able to maintain good blood sugar control may be able to delay or prevent the onset of diabetes-related consequences. While treatment with traditional drug therapies is initially effective in lowering blood sugar levels, it eventually fails to maintain these levels over time. "Avandia has been shown to decrease insulin resistance, thereby providing sustained blood sugar control," added Dr. Krause.
Avandia for 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 antidiabetes 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.
Diabetes
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.
SmithKline Beecham -- one of the world's leading healthcare companies-discovers -- develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com. For Avandia information, visit http://www.avandia.com.
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