Avandia users should take medical advice

People taking Avandia (Rosiglitazone) to treat Type 2 diabetes should ask their doctor or diabetes specialist whether or not to change their medication.

This is the advice of Diabetes New Zealand, following reports that controlled clinical trials in the United States have shown a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking GlaxoSmithKline's widely used drug, also known as rosiglitazone.

Avandia (Rosiglitazone) is available on prescription but is not government funded in New Zealand.

Dr Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease.

Writing in the New England Journal of Medicine, Dr Nissen and colleagues at the Cleveland Clinic analysed 42 clinical trials involving close to 28,000 patients and said more than 65% of deaths among diabetic patients in trials of the drug could be attributed to heart disease.

GlaxoSmithKline strongly disagreed with the conclusions of the report, which was based on an analysis of other studies, and 'stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks.'

The US Food and Drug Administration (FDA) said those taking Avandia, especially those with underlying heart disease or at high risk of heart attack, should talk to their doctor about the research findings as they evaluate available treatment options for Type 2 diabetes.
FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies.

'Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments.

'For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualised treatment decisions.'

Steven Galson, director of FDA's Center for Drug Evaluation, said FDA is weighing sources of data, some with conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia.

GlaxoSmithKline provided FDA with a pooled analysis of 42 randomised, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with Type 2 diabetes.

'The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40% greater risk of heart attack and other heart-related adverse events than those treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease,' the FDA statement concluded.

For further information go to The Medsafe Datasheet on Avandia http://www.medsafe.govt.nz/profs/Datasheet/a/Avandiatab.htm

Or contact Mike Smith, President, Diabetes New Zealand, phone 0800 438 6453.

Published on this website on Tue, 05 Jun 2007

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