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NICE makes landmark decision to approve rival to warfarin

By Nigel Praities

NICE has given a green light to the first oral anticoagulant potentially to rival warfarin for over half a century.

The final appraisal determination on dabigatran etexilate says the treatment is as cost-effective as other anticoagulants used after total hip or total knee replacement surgery.

It raises hopes the treatment may replace warfarin as the drug of choice for patients with atrial fibrillation or after valve replacement.

Professor David Fitzmaurice, professor of primary care at the University of Birmingham and a GP in the city, said the decision was an ‘important advance'.

‘This is the first credible alternative to warfarin. If successful in the treatment trials, dabigatran is likely to have an impact on anticoagulant clinics with many patients being treated with this new product,' he said.

A study by Professor Fitzmaurice published in 2003 showed nearly two in 100 patients treated with warfarin in a primary care clinics have a serious adverse event each year.

Jacqueline Rudge, a nurse running an anticoagulation clinic in Colchester, Essex, said any drug that could reduce the complications seen with warfarin would be ‘wonderful'.

‘Some patients just don't like taking warfarin,' she said. ‘There are many interactions and they develop adverse events such as diarrhoea or nasty rashes, so anything that could alleviate this would be welcome.'

A spokesperson from manufacturer Boehringer Ingelheim welcomed the endorsement from NICE and said comparative clinical trials comparing dabigatran with warfarin were underway.

The company said dabigatran had almost no drug-food interactions and a low potential for interaction with drugs that are metabolised by P450 enzymes.

Dabigatran is licensed for the primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

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