In a new study,GlaxoSmithKline refuses to accept the claim that its product Avandia puts patients at high risk of heart attacks; diabetologists say the final word is not yet out
A GlaxoSmithKline (GSK) study rebuts claims that it’s much criticised diabetes drug Avandia is linked to heart attacks. And while the health care company’s study on more than 4,000 patients has also been published in The Lancet (June 5) issue,diabetologists feel that the last word has not been said about the issue.
The American Diabetic Association and a European Diabetes Association had recommended to doctors to stop giving the drug ‘avandia’ after studies showed that it put patients at higher risk of heart attacks. However,GSK reported their recent study that shows Rosiglitazone (brand name Avandia) has no increased overall cardiovascular risk compared to other commonly used diabetes medicines.
Clinical trial results of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study,presented at the American Diabetes Association (ADA) meeting 2009,showed that overall rates of cardiovascular hospitalisation and cardiovascular death were similar in patients taking rosiglitazone compared to those consuming metformin and sulfonylurea.
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The results from the 4,447-patients US based study showed that the primary endpoint consisting of cardiovascular hospitalisation or cardiovascular death (which includes heart attack,congestive heart failure,and stroke) was not statistically different between the Rosiglitazone groups (321 events,14.5 per cent) compared to the patients receiving control medications [Metfomin and Sulfonyurea (323 events,14.5 per cent).
This data is very relevant in the Indian context,given that India has over 42 million diabetics and every fifth diabetic in the world is a native Asian Indian” said Dr Sadhna Joglekar,GlaxoSmithKline’s VP Medical,Regulatory and Clinical Research,India. Avandia is marketed in India by GSK as Windia.
However,diabetologists like Dr C S Yajnik feels that the last word has not been said about this issue. Larger studies are needed and while the drug is in use,people are not using it on a large scale. The present study is bound to generate debate in the medical world, he said. According to Dr Abhay Mutha diabetologist,The drug has been under a lot of scrutiny. He however felt that in India it did not pose much of a problem.