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Diabetes drug setback for GSK
Pharmaceuticals giant GlaxoSmithKline beat a retreat after US research indicated its second-best-selling drug, diabetes treatment Avandia, raised the risk of heart attacks. Research published in the New England Journal of Medicine suggests the drug, taken by six million people since its approval in 1999, could raise the risk of a heart attack by more than 40 per cent and increased the risk of heart death by around 65 per cent.
Scientists analysed the results of 40 trials of Avandia – also known as rosiglitazone – involving 28,000 people and concluded 65 per cent of deaths among diabetic patients could be attributed to heart disease. ‘Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes,’ said Dr Steven Nissen, chairman of cardiovascular Medicine at the Cleveland Clinic, which led the study.
US regulators are aware of a ‘potential safety issue’ with the drug, but GlaxoSmithKline insists it is ‘very confident’ about Avandia. ‘We believe its significant benefits continue to outweigh any treatment risks,’ it said in a statement.
‘FDA (the US Food and Drug Administration) is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related death in patients treated with Avandia,’ commented Steven Galson, head of FDA’s Center for Drug Evaluation and Research. ‘We will complete our analysis and make the results available as soon as possible.’
The setback couldn’t have come at a worse time for the FTSE 100 behemoth – market value £77.6 billion – which had enjoyed an encouraging six per cent rise in US prescriptions for Avandia only last month following a difficult period of lacklustre growth.
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