A LARGE US study has reported serious heart risks with a drug used to treat type 2 diabetes.
An analysis of 56 clinical trials found Avandia, one of number of drugs manufactured by GlaxoSmithKline (GSK) in Cork, increased the chances of a heart attack by 28 to 39 per cent, according to researchers at the Cleveland Clinic in Ohio.
However, it did not increase risk of death from cardiovascular disease.
The Ohio researchers were updating a 2007 study that sparked intense debate about the drug which is used to reduce the amount of sugar in the blood.
Officials from the US Food and Drug Administration (FDA) are expected to look at the data next month before making a decision on whether the drug should stay on the market.
GSK said last night that results from six controlled clinical trials have been reported since the FDA previously reviewed questions about the cardiovascular safety of the drug in 2007. “Taken together, these trials show that rosilglitazone does not increase the overall risk of heart attack, stroke or death,” it said.
Meanwhile, the Irish Medicines Board said Avandia has been authorised in the EU since 2000.
“At the time of the authorisation, the medicine was contraindicated in patients with heart failure or a history of heart failure. An increased risk of heart failure with rosiglitazone was already well documented,” it said.
It added that in September 2008, a scientific advisory group (SAG) of experts in diabetes and cardiovascular diseases met to discuss the benefit-risk balance of rosiglitazone and its place in diabetes therapy.
“The SAG concluded that rosiglitazone retained a small, if diminishing, place in therapy, and that no further restrictions on its use were necessary,” it said.
Furthermore it said a review in February this year did not show an increase in deaths from heart problems associated with the drug.
It is not clear how many Irish patients are on the drug but GSK said the numbers are likely to be small as it is not the main treatment prescribed for diabetes.
Dr Steven Nissen, the lead author of the Ohio study and an outspoken critic of Avandia, said the results from more than 35,000 patients gave a more complete picture that reinforced his earlier concerns.
“A drug that increases the risk of heart attack by a third or more in diabetics represents a huge public-health burden,” he said.
It was reported last month that GSK has agreed to pay about $60 million in the first settlements of about 700 lawsuits alleging the drug causes heart attacks and strokes in some users.
Glaxo officials declined to comment on the settlements. They said the company continues to prepare for trials over Avandia scheduled for this year.
(Additional reporting Reuters)