FOR IMMEDIATE RELEASE
NEW DATA SUGGEST POTENTIAL LONG-TERM EFFICACY OF AVANDIA®
Improvements in Blood Sugar Control Achieved in Patients Receiving Treatment with Avandia as Monotherapy or in Combination Therapy
TORONTO, Ontario (June 20, 2002) Results of a study presented today indicate that Avandia® (rosiglitazone maleate), provided sustained improvements in blood sugar (glucose) control in patients with type 2 diabetes receiving up to 42 months of Avandia as monotherapy or in combination with metformin or a sulfonylurea. Data are taken from long-term, open-label extension trials in patients who continued Avandia monotherapy for at least 42 months or received combination therapy with metformin or a sulfonylurea for at least 30 months.
Long-term control is important in helping to reduce the risk of diabetes-related complications, such as heart disease, stroke, blindness, kidney failure and non-traumatic lower limb amputations. These data were presented at the 84th Annual Meeting of the Endocrine Society in San Francisco.
"Because the United Kingdom Prospective Diabetes Study demonstrated that blood sugar control declines over time with older, traditional monotherapy, it's critical that we continue to search for therapeutic options that may provide sustained blood sugar control," said Martin Freed, M.D., Vice President, North America Head and Global Lead, Metabolism Therapeutic Area, Clinical Development and Medical Affairs, GlaxoSmithKline. "These data are promising and provide the rationale for GlaxoSmithKline's ADOPT (A Diabetes Outcomes and Progression Trial) which is a four-year international outcomes study involving more than 4,000 people with type 2 diabetes."
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Importance of Type 2 Diabetes and the Goal of Control
Type 2 diabetes has been called a "silent killer" because many people do not become aware that they have the disease until they develop one or more of its complications. Over time, untreated or poorly managed type 2 diabetes can lead to serious diabetes-related complications, including heart disease, stroke, kidney disease, nerve damage and blindness.
In fact, increases in hemoglobin HbA1C levels - an indicator of blood sugar control over the preceding two to three months - have been shown to be associated with the development of diabetes-related complications, including cardiovascular disease. To help minimize complications, guidelines from the Clinical and Scientific Section of the Canadian Diabetes Association advocate HbA1C levels of less than or equal to seven per cent as the target for blood sugar control.
Study Suggests Sustained Control with Avandia
Avandia as monotherapy or in combination with metformin or sulfonylureas has previously been shown to produce significant improvements in blood sugar control in people with type 2 diabetes compared with placebo and active comparators. These new data report results of long-term open-label extension studies of patients receiving Avandia as monotherapy or in combination with metformin or sulfonylurea therapy.
In the combination therapy group, patients received Avandia (8 mg/day) plus metformin (2.5 g/day) or Avandia (4 mg/day) plus sulfonylurea for at least 30 months. With the addition of Avandia, those patients completing at least 30 months of therapy achieved clinically significant reductions in HbA1C levels (1.5 per cent from baseline). Patients taking Avandia (8 mg/day) monotherapy for at least 42 months also achieved a clinically significant reduction in HbA1C levels (.9 per cent from baseline.)
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Type 2 Diabetes
According to the Canadian Diabetes Association, more than two million Canadians have diabetes, 90 per cent of whom have type 2 diabetes. By 2010, more than three million Canadians will have the disease. Characterized by high blood sugar levels, type 2 diabetes is caused by defects in the body's ability to produce enough insulin and/or effectively use the insulin it already makes - a condition called "insulin resistance."
Diabetes is one of the leading causes of death by disease in Canada. In Canada, it is estimated that at least $9 billion ($US) is spent annually on treating people with diabetes and its complications. A person with diabetes incurs medical costs that are two-to-five times higher than those of a person without diabetes.
Avandia for Type 2 Diabetes
Avandia is an insulin sensitizer that works by helping the body use its own insulin more effectively. Along with diet and exercise this medication helps improve blood sugar control. Usually taken once a day it is a first line oral treatment for patients with type 2 diabetes.
Avandia is an effective treatment for type 2 diabetes as both monotherapy and in combination with metformin (one of the most commonly used anti-diabetic agents) and in combination with sulfonylureas. The most common side effects reported in clinical trials with Avandia include upper respiratory tract infections, headache and back pain. If patients have severe heart failure or serious liver disease, Avandia is not recommended.
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About GlaxoSmithKline
GlaxoSmithKline Inc. - 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. In Canada, GlaxoSmithKline employs approximately 1,800 people and is a top 20 investor in Canadian research and development, contributing more than $100 million annually. The company is also one of the top 10 corporate charitable donors, investing more than $6.5 million annually and is recognized as one of the 50 best companies to work for in Canada.
For further information about this news release, please contact:
Nancy Shea/Bev Warford
Edelman Public Relations Canada
Tel: (416) 979-1120
Carlo Mastrangelo/Catherine Jackson
GlaxoSmithKline Inc.
Tel: (905) 819-3000
Avandia® is a registered trademark, used under license by GlaxoSmithKline Inc.