GSK statement on Avandia study approach presented at American Heart Association Scientific Sessions 2008
Issued: Wednesday, 12 November 2008, New Orleans, LA - GlaxoSmithKline (NYSE: GSK) is encouraged by findings from the Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH) study which demonstrated that treatment with AVANDIA® (rosiglitazone maleate) may stall the progression of coronary atherosclerosis.
In the APPROACH study, treatment with AVANDIA was associated with reduced atherosclerotic plaque volume compared to the sulfonylurea glipizide, however the difference between groups for the main study endpoint did not reach statistical significance.
In terms of safety, there were no unexpected differences between AVANDIA and glipizide. The overall incidence of cardiovascular events was comparable between groups, although this study was not powered to evaluate clinical outcomes.
Important Safety Information about AVANDIA® (rosiglitazone maleate)
Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes. Taking AVANDIA with insulin or nitrates is not recommended.
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.
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.
Before taking AVANDIA, review your medical history and tell your doctor if you:
Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.
For more information about AVANDIA, please see Medication Guide. For further information on AVANDIA, please see full Prescribing Information at www.AVANDIA.com [1].
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.
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Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.
Links:
[1] http://www.avandia.com/