Healthcare Industry News:  osteoporosis 

Biopharmaceuticals Endocrinology Cardiology FDA

 News Release - July 31, 2007

Endocrinologists Welcome FDA Avandia Recommendation

JACKSONVILLE, FL--(Healthcare Sales & Marketing Network)--Jul 31, 2007 -- The American Association of Clinical Endocrinologists (AACE), along with the rest of the medical community, has watched with concern the debate regarding usage of GlaxoSmithKline's rosiglitazone (Avandia) in diabetes and the question of whether it increases cardiovascular risk. AACE welcomes the recommendation of the Food and Drug Administration endocrine advisory panel, which voted almost unanimously yesterday that Avandia remain in the US market.

At the same time, AACE recognizes the strong statement of the panel that the drug may increase risk of cardiovascular disease (CVD). We share the concerns of many on the panel that the methodology used in suggesting an association between Avandia and CVD was far from optimal. Three well-designed long-term randomized controlled studies, the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D), the Action to Control Cardiovascular Risk in Diabetes (ACCORD), and the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trials, will greatly enhance our understanding of whether or not this agent helps to decrease diabetes complications.

Physicians can continue to treat persons with diabetes who are well controlled with Avandia, knowing that it has been shown useful and effective in controlling glucose, a crucial step to preventing diabetes complications. AACE will continue to support the development of approaches to manage the issues of weight gain, of fluid retention, and of reduced bone mass in diabetic patients receiving both Avandia and Takeda's pioglitazone (Actos), to optimize clinical decision-making in the appropriate use of these important glucose-lowering medicines.

About AACE

AACE is a professional medical organization with more than 6,000 members in the United States and 84 other countries. Founded in 1991, AACE is dedicated to the optimal care of patients with endocrine problems. AACE initiatives inform the public about endocrine disorders. AACE also conducts continuing education programs for clinical endocrinologists, physicians whose advanced, specialized training enables them to be experts in the care of endocrine disease, such as diabetes, thyroid disorders, growth hormone deficiency, osteoporosis, cholesterol disorders, hypertension and obesity. For further information about AACE and the Annual Meeting, visit the AACE web site at www.aace.com.



Source: American Association of Clinical Endocrinologists

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