Anti-stroke drug ‘available later this year’

Anti-stroke drug ‘available later this year’

A new blood-thinning pill capable of preventing thousands of strokes a year could be available to up to a million patients later this year, cardiologists hope.

By Stephen Adams 6:30AM BST 05 Apr 2011

They are describing Pradaxa as the “holy grail” of blood-thinning drugs and the first major pharmacological breakthrough for people at an increased risk of having a stroke in 50 years.

Up to 1.2 million people in Britain live with a condition called atrial fibrillation (AF) – having a quick and irregular heartbeat – which puts them at an increased risk of stroke. The heart condition accounts for 14 per cent of the 150,000 strokes that happen annually, or more than 20,000 a year.

Some 500,000 AF sufferers are currently prescribed the blood-thinning drug warfarin, traditionally used as rat poison.

For 50 years it has been used to lower the risk of a type of stroke caused by blood clots, known as ischaemic stroke, among people with AF.

However, patients need regular blood checks to ensure they are receiving the right dosage, as levels that are too high can cause dangerous bleeding. It can also interfere with other drugs like antibiotics, while changes in diet can affect how well it works.

Now updated results of a clinical trial have shown that Pradaxa, also known by its generic name dabigatran etexilate, can reduce the number of strokes by a third compared to using warfarin.

A study of 18,000 people with atrial fibrillation (AF) has found that taking 150mg of Pradaxa daily reduces the risk of stroke by between 30 and 39 per cent, depending on the type of AF.

The results of the research, led by Dr Greg Flaker, a cardiologist at Missouri University in the US, were presented to the American College of Cardiologists on Monday.

Prof Martin Cowie, a consultant cardiologist at the Royal Brompton Hospital in London, said the drug was likely to be approved for patients with AF by the European Medicines Agency (EMA) in the next couple of months. It has recently received approval from its American equivalent, the Food and Drugs Administration (FDA).

He said of Pradaxa: “This drug seems to prevent clots better than warfarin but with less bleeding, which is pretty much the holy grail for such drugs.”

It works by lessening the effects of thrombin, the protein that controls clotting.

Prof Cowie added: “I have heard rumours that there might be a decision from the EMA in the next two to three months.”

He thought there would be a lot of interest from patients in it, because they would not have to undergo regular blood checks or watch their diet so closely.

However, the cost could be prohibitive. Whereas warfarin costs as little as £1 a month, the new drug is likely to be substantially more than that.

The drug is already licensed for use in patients who have had hip or knee replacements and in this group the cost is £4.20 per day.

However, a spokesman for Boehringer Ingelheim, which makes the drug, said the cost was likely to be much less for patients with AF as the market was much larger.

Once the EMA grants licensing approval, it will be up to the National Institute for Health and Clinical Excellence (Nice) to decide to whom it can be prescribed on the NHS in England and Wales.

According to research by The Stroke Association, only 40 per cent of GPs say they will treat AF patients with warfarin because of safety concerns.

Dr Peter Coleman, the charity’s deputy director of research, said: “There is a definite need for a useful, alternative treatment to warfarin which can be used when warfarin is not appropriate.

“The findings from this study provide a strong, positive backing for dabigatran which appears to be an easier treatment to manage and therefore has the potential to improve the quality of life for many people.

“We’re very interested to see how this potential treatment progresses.”

One Response to Anti-stroke drug ‘available later this year’

  1. Myrna says:

    A very interesting read……thankyou.

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