UEA research warns about diabetes drugs

MARK NICHOLLS UEA researchers have warned that two drugs commonly prescribed to treat diabetes in the UK double the risk of heart failure.

MARK NICHOLLS

UEA researchers have warned that two drugs commonly prescribed to treat diabetes in the UK double the risk of heart failure.

They say the drugs involved - Rosiglitazone (Avandia) and Pioglitazone (Actos) - were taken by more than 1.5 million people in the UK last year but safety concerns have now emerged.

UEA researchers say that earlier this year a link was drawn between Rosiglitazone and heart attacks.

Their new research confirms that treatment with the drugs, known as thiazolidinediones, doubles the risk of heart failure and that fluid retention caused by the drugs provides the trigger.

The findings are based on analysis of more than 78,000 patients, which estimates that one in every 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure.

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Rosiglitazone (Avandia) and Pioglitazone (Actos) are recommended by the National Institute of Health and Clinical Excellence (NICE) for the treatment of Type II diabetes and the use of such drugs has doubled over the last three years.

The new research was undertaken by Dr Yoon Loke, a clinical pharmacologist at UEA's School of Medicine, Health Policy and Practice, working with colleagues at Wake Forest University in the US.

The results are published in the August edition of the journal Diabetes Care.

Dr Loke said: "This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed NHS services. I think Nice should re-evaluate their decision to recommend these diabetes drugs."

The researchers also looked in detail at more than 200 cases of patients with heart failure related to the diabetes drugs and found that the problem developed even in patients taking low doses of the drugs.

While heart failure is often thought to be a problem affecting older patients, the researchers also found that one quarter of cases occurred in people younger than 60.

The manufacturers' information leaflets say that rosiglitazone and pioglitazone should not be used in patients known to have heart failure, but this research indicates that the drugs can provoke the problem even in those without a history of heart disease.

"Most patients in the studies did not have heart failure prior to starting on treatment with these drugs," said Dr Loke.

"There doesn't seem to be a group of patients who are safe from these side effects.

"I think Nice should re-evaluate its decision to recommend these diabetes drugs."

More than 1.9 million people in the UK are Type 2 diabetic and up to 750,000 more are undiagnosed.

Two advisory panels for the US Food and Drug Administration are re-examining both drugs in light of concerns about their risks, though the European Medicines Agency (EMEA) said it was not planning to publish a statement on the drugs.

A statement from Nice said: "If the EMEA decides on the basis of this new research that the risks posed by these two glitazones outweigh their benefits, they will issue updated prescribing advice to healthcare professionals."

A spokesman for GlaxoSmithKline (GSK), which manufactures Avandia, said heart failure was commonly associated with diabetes. Dr Alastair Benbow, European medical director of GSK, said the research had been published previously and provided no new information.

The Medicines and Healthcare products Regulatory Agency (MHRA) said in conjunction with the EMEA and other European regulatory authorities, it was currently reviewing all the available data on the cardiovascular safety of rosiglitazone and pioglitazone.

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