Scientists link diabetes drugs to heart failure

fyi...

US may ban treatments used by hundreds of thousands in UK

Sarah Boseley, health editor
Friday July 27, 2007
The Guardian

Two of the most commonly used drugs for diabetes, which were taken by hundreds of thousands of mostly overweight people in the UK last year, are causing widespread heart failure, scientists warn today.

Use of the drugs, prescribed by doctors for type II diabetes, has doubled in the past three years as a consequence of a growing obesity problem. Last year 1.8m prescriptions were written across the UK, which scientists say equates to several hundred thousand patients taking the drugs which are recommended for use across the NHS by the National Institute for Health and Clinical Excellence (Nice).

But researchers today call on Nice to think again, revealing that as many as one in every 50 patients taking the drugs Avandia (rosiglitazone) and Actos (pioglitazone) over a period of 26 months will have to be hospitalised for heart failure.

The class of drugs, they say in the journal Diabetes Care, doubles the risk of heart failure, and even those with no history of heart problems are affected.

"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," said Dr Yoon Loke, a clinical pharmacologist at the University of East Anglia who carried out the research with Wake Forest University in the US. "I think Nice should re-evaluate their decision to recommend these diabetes drugs."

Concerns about the safety of the drug were triggered in May when a leading US cardiologist published evidence of a link to heart attacks and death. The manufacturers strongly contested his study in the New England Journal of Medicine.

But today's evidence will add urgency to a special meeting of the US regulator, the Food and Drug Administration (FDA) which was already scheduled for Monday to discuss the safety of the drugs which are taken by 7 million people in the US.

Global sales of Avandia, made by the British company GlaxoSmithKline, have dropped by 22% in the US since the heart attack data was published in May, but are still worth £349m.

However, in Europe sales have continued to grow by 20% to £63m. Avandia is the company's second best-selling drug.

Dr Loke told the Guardian: "These drugs are no longer cost-effective by Nice's criteria. We spent about £70m a year on these two drugs. It is a huge amount ."

He and his American colleagues pooled data from 78,000 patients who have taken the drugs, some of them during the manufacturers' trials. They also looked closely at the cases of 200 people who suffered heart failure and found they were not people who were obviously at risk.

"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."

The European Medicines Agency (EMEA), which licensed the drugs, says it is reviewing the evidence and will not comment for the time being. Nice says it will take into account any new information when it updates its guidance on the diabetes treatment in February, but that any decision to limit prescribing of the drugs rested with the EMEA.

Alastair Benbow, European medical director for GlaxoSmithKline, said of the study: "It is well recognised that the class of drug can cause fluid retention. It is wholly different from the issue raised previously about heart attacks and cardiovascular deaths."

He said fluid retention could be resolved if the patient was well monitored and prescribed diuretics. Even heart failure could be treated in hospital. "What is missing here is the benefit these drugs provide." The drugs kept blood sugar levels low, preventing serious effects of the disease such as blindness and amputations, he said.

Takeda, manufacturers of Actos, last night declined to comment.

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Thu. Jul 26, 10:37pm

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