Doctors demand freeze on use of diabetes drug for heart patients

SCOTTISH doctors have said there is "no defence" for the use of a widely prescribed diabetes drug after warnings that it should not be used in patients with heart problems, The Scotsman can reveal.

The consultants, who work in the NHS Greater Glasgow and Clyde area, recommend no new patients are given Avandia – also known as rosiglitazone.

They said GPs should look carefully at those already taking the drug, used to treat type 2 diabetes, and stop the treatment if any risk factors are found.

One senior source said consultants "felt very uncomfortable with its ongoing usage" and it was likely that GPs would be prevented from prescribing the drug.

In patients with type 2 diabetes, the pancreas does not make enough insulin to control sugar levels in the blood, or the body is unable to use insulin effectively. The illness can often be controlled through lifestyle changes such as diet, weight control and physical activity. Drugs are prescribed if symptoms persist.

Avandia, made by GlaxoSmithKline is used by 150,000 patients in the UK and it is estimated that 15,000 take it in Scotland, more than 3,000 of them in the Greater Glasgow and Clyde area.

There are signs of other health boards introducing measures. Research published in the New England Journal of Medicine in May suggested Avandia may raise the risk of heart attacks by 43 per cent, and the risk of cardiovascular deaths by 64 per cent.

In January, the European Medicines Agency (EMEA) said the drug should carry extra warnings, including the fact that it must not be used in patients with acute coronary syndromes such as angina.

However, a review of the whole class of drugs – glitazones – by the agency has concluded that the benefits of Avandia still outweighed the risks.

The methodology of the research that has raised concerns about the drug has been criticised, and other studies have suggested the risks are uncertain.

Despite this, the Glasgow doctors are making recommendations to the area drug and therapeutics committee (ADTC) that could lead to many patients being taken off the medicine.

The ADTC will consider the recommendations at a meeting this month before producing guidance for all doctors in NHS Greater Glasgow and Clyde, Scotland's largest health board.

The consultants' concerns are revealed in the minutes of a meeting of the Managed Clinical Network for Diabetes in February, where they discussed the new guidance from the EMEA.

"The consensus was that there was no defence for its use unless the goalposts changed in times to come," the minutes read.

A senior source present at the meeting told The Scotsman that while some consultants thought Avandia should be withdrawn completely, the majority view was that doctors needed to look very closely at patients on the drug and decide whether they should continue with it.

"It is a case of looking carefully at the patients who are on rosiglitazone, making sure that it's safe to use it. And if it is not safe at all, then stop it completely."

The expert thought it was likely the drug would be placed on a restricted formulary, meaning only specialist consultants could prescribe it. GPs would no longer be able to issue Avandia.

A spokeswoman for the health board said: "

We are aware of the safety issues surrounding the drug including the recent correspondence from the EMEA, and prescribers have been kept fully up to date with the safety information."

NHS Forth Valley said that since the initial study was published last May, it had told doctors that another drug, Actos, "should be used as the glitazone of choice for new patients".

Paul Beardon, head of prescribing management at NHS Dumfries and Galloway, said it was likely that Avandia would be withdrawn from its formulary in the next month.

A spokeswoman for GlaxoSmithKline said: "After an extensive review of the data, the European medicines regulatory agency concluded in October last year that the benefits of rosiglitazone in type 2 diabetes continue to outweigh its risks – in other words, that rosiglitazone is still of value in the treatment of patients with type 2 diabetes.

"A revision to the labelling for rosiglitazone – the information that serves as a guide for doctors about the appropriate use of this medication – was announced by the European medicines regulatory agency in January. The regulators did not make any recommendations to doctors about switching treatment."

The company added: "GlaxoSmithKline believes that rosiglitazone remains a valuable medicine for many patients with type 2 diabetes and an important treatment option for doctors, when used appropriately, and that the decision about a patient's treatment should be made by the doctor, in consultation with the patient and in line with the prescribing information."

• Additional reporting by Marisa de Andrade

Making cells more insulin friendly

ROSIGLITAZONE – better known as Avandia – is part of a class of drugs known as thiazolidinediones, commonly referred to as glitazones.

The glitazones are used to treat adult patients with type 2 diabetes, particularly people who are overweight.

In patients with type 2 diabetes, the pancreas does not make enough insulin to be able to control sugar levels in the blood, or the body is unable to use the insulin effectively.

The illness is normally first treated by lifestyle changes, such as alterations in diet and increased exercise. Where that has no effect, drugs are then prescribed.

The glitazones work by making cells in the fat, muscle and liver more sensitive to insulin, which means the body can make better use of what insulin it produces.

This leads to reduced blood sugar levels.

'FEELING WAS DREADFUL'

VENETIA Murray was diagnosed with type 2 diabetes in May 2002.

"I had lots of symptoms for about three years before I was diagnosed. I was really thirsty, I was very tired and had other unpleasant symptoms too," she said.

In October 2003, Ms Murray was put on the drug Avandia to help to control her condition.

"In the following years I started to feel extremely tired, with a gripping feeling in my chest, but no pain really.

"By 2006 it was dreadful, and by 2007 it was unspeakable. But I did not feel any pain, just this tight, gripping feeling."

In 2007, the 72-year-old was diagnosed with a heart problem which would mean she needed surgery.

"I had to have a quadruple bypass last September and a valve replacement. The surgery lasted 7 hours, and I was in intensive care for four weeks. I also developed MRSA."

Ms Murray, of Haddington, East Lothian, is still recovering from the major surgery. She is unsure whether or not her problems could be linked to the drugs she was taking for her diabetes.

"The trouble is that there are a lot of things that if you have diabetes you can get heart problems anyway," she said.

Ms Murray came off Avandia last summer after hearing concerns raised about the drug in news reports.