22 Aug 2014

Concerns over risks and benefits of stroke drug

The Department of Health’s drug watchdog agreed today to review the risks and benefits of a frontline stroke medicine given to between 10 and 20 per cent of the 90,000 people who suffer a stroke in England each year.

In a letter published today in the medical journal the Lancet, a former stroke doctor at Birmingham Heartlands hospital, Dr Roger Shinton, raises questions about the benefits of the drug alteplase.

It is used to break up blood clots that cause some strokes. It is given in specialist stroke centres across England to minimise the risks of long-term disability associated with strokes.

Four years ago stroke care in England was reorganised to ensure that all patients diagnosed with a stroke are taken directly to a specialist stroke centre for treatment. If they arrive at the centre withing four and a half hours, suitable patients are given alteplase.

The drug can cause fatal bleeding in 2 per cent of cases, but the current evidence from clinical trials suggests that these risks outweigh the benefits. The data suggest those who survive the drug and their stroke are 10 per cent more likely to be independent six months after treatment.

Dr Shinton argues there are problems with the clinical trial data on which these conclusions are based. In his letter to the Lancet he argues largest independent review of the drug, published in 2012, contains potential biases that could make the long-term benefits of the drug appear better than they really are.

Concerns about the risks and benefits of the medicine have also been shared by physicians in the US and Australia.

The drug watchdog, the Medicines and Healthcare products Regulatory Agency, today responded, saying that their recent review of the medicine concluded it should remain a frontline treatment for stroke.

“The evidence presented did not change the favourable balance of benefits and risks for alteplase, which remains an effective medicine for treating ischaemic stroke,” it said in a statement.

“However in order to be assured that all relevant sources of evidence have been taken into consideration the CHM has advised that an expert working group should be set up.”

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