Pradaxa Gets The Nod In UK Too

by Gopalan on  September 8, 2011 at 7:07 AM Drug News
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The atrial fibrillation drug Pradaxa has got the not in the UK too. The anticoagulant had won the US FDA's approval last year. It works to neutralize thrombin, an enzyme essential in blood coagulation.
 Pradaxa Gets The Nod In UK Too
Pradaxa Gets The Nod In UK Too

The drug can help reduce the risk of stroke in by more than a third among elderly people with atrial fibrillation.

An estimated 15 per cent of the 150,000 strokes suffered each year in Britain are caused by atrial fibrillation, which can also leave sufferers out of breath and exhausted.

The standard treatment for the problem is warfarin, best known as a rat poison. It has been on the market since 1954. But many patients stop taking the drug and some GPs do not even prescribe it because of the difficulties in checking blood tests regularly and monitoring diet, in order to ensure it is effective.

With Pradaxa, marketed by Boehringer Ingelheim, the patients do not need to watch what they eat or drink as closely, nor do they need regular trips to the doctor to ensure they are taking the right dose.

As a result of the lower monitoring costs for the NHS, manufacturers hope Pradaxa will save money as well as saving thousands of lives every year among the 1.2million people in Britain who have atrial fibrillation.

However although the pills cost just Ģ2.52 a day, England's drug rationing body, Nice, has asked for more data on the savings it will bring before recommending it across the health service.

In the meantime, the drug has been approved by the European Medicines Agency and individual GPs can prescribe it from Monday.

Prof John Camm, head of the department of Cardiac and Vascular Sciences at St George's Hospital, London, said: "Often the first time someone finds out they have atrial fibrillation is when they have a stroke, which is a real disaster.

"A new anticoagulant, like Pradaxa, is going to be very important for eligible patients."

In a trial of 18,000 patients across the world, those who took the 150mg dose twice daily had a 35 per cent a year reduction in stroke risk compared with those on warfarin. Those who took a 110mg dose also had a lower risk of bleeding, a possible side-effect of taking any blood-thinning drug.

Jon Barrick, Chief Executive of The Stroke Association says; ""For a long time there has been a need for a useful alternative treatment to warfarin which can be used when warfarin is not appropriate. This new medication appears to be very promising, however it's important to note that it won't be suitable for all and every AF patient needs to be treated on a case by case basis to ensure that they receive the best possible treatment for them."

A study presented at the European Society of Cardiology congress in Paris last week showed that a rival to the new drug, called apixaban, cuts deaths from any cause as well as reducing strokes.

Source: Medindia

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