Avandia is - - - - dead

The Scotsman, 7 April 2008
Doctors demand freeze on use of diabetes drug for heart patients
By LYNDSAY MOSS and MARISA DE ANDRADE

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....

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. [Medicine 101: The primary goal of treatment in diabetes is to reduce cardiovascular disease] ...

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A senior source present at the meeting told The Scotsman that while some consultants thought Avandia should be withdrawn completely, the majority view was that doctors needed to look very closely at patients on the drug and decide whether they should continue with it.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

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 [presumably hidden and unhidden], 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. [See above] ....

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 [this seems to be begging a tiny question] and that the decision about a patient's treatment should be made by the doctor, in consultation with the patient" [Template Consultation: "Mrs Jones, the main concern in treating diabetes is to give you as normal a lifespan as possible and to reduce cardiovascular disease. The best evidence we have about this drug is that it increases the risk of heart attacks by 43 per cent and cardiovascular death by 64 per cent. Would you like to take it?"]

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Comments on: Avandia is - - - - dead

 

Blogger Jenny said ... (April 07, 2008) : 

Sadly, doctors are being convinced by cleverly spun data to transfer patients to the related TZD drug, Actos.

Actos may have a better effect on artery thickening. However, it IS known to cause congestive heart failure in people who did not have it when they started the drug.

And far worse, Actos causes osteoporosis, which is a major killer of older people. It does this by turning bone stem cells into fat cells, which then suck up glucose and reduce blood sugar. But the bone is weakened and eventually people start developing bone fractures.

This effect was clearly seen in the latest Actos study Dr. Nissen is promoting as showing how good Actos was for the heart.

Long term, it will not do any of us much good to prevent heart disease at the cost of our bone health.

 

Blogger Aubrey Blumsohn said ... (April 07, 2008) : 

As a non-diabeteologist I too find it strange that Actos is being promoted as the alternative. However, to be fair, in diabetes the increase in skeletal disease would have to be massive to outweigh any relevant cardiovascular benefit (if there is such benefit).

Osteoporosis is not a "major killer" despite the spin, and the association between osteoporosis and mortality is only in part causal. 5 year survival is reduced by about 20% in people with hip or vertebral fracture (and is related in good part to other comorbid conditions). the median age of hip fractures is around 80 years.

 

Anonymous Anonymous said ... (April 08, 2008) : 

Now see this

FDA - GSK Hid data over Avandia
http://www.fda.gov/foi/warning_letters/s6714c.pdf

http://www.pharmalot.com/2008/04/fda-glaxo-failed-to-report-avandia-studies/

 

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