New anticoagulant could revolutionise AF treatment
The Government has referred a new anticoagulant drug to the National Institute for Clinical Excellence after concluding it could benefit up to a million patients with atrial fibrillation.
GP experts said ximelagatran (Exanta) first in a new class of drugs called direct thrombin inhibitors could revolutionise primary care-based treatment.
Ximelagatran used in a fixed dose and without coagulation monitoring is as effective as warfarin and associated with less bleeding, according to data from the international SPORTIF trials of more than 7,000 patients.
A Department of Health spokesman said: 'About one million people 300,000 of them over 75 suffer from atrial fibrillation and are at enhanced risk of stroke. There is strong evidence to suggest ximelagatran could offer significant patient benefit.'
He said officials had moved fast to refer the drug to NICE so guidance could be published in early 2005, when
Exanta is expected to get a
licence for stroke prevention.
SPORTIF trial co-author Professor Gary Ford, consultant stroke physician at the Freeman Hospital in Newcastle upon Tyne, said the drug's biggest advantage over warfarin was that it did not require continuous coagulation monitoring and dose titration.
Many GPs were reluctant to prescribe warfarin because of 'time-consuming and resource intensive' monitoring and the high risk of bleeding meaning around half of patients eligible for treatment still went without, he added.
Professor David Fitzmaurice, professor of general practice at the University of Birmingham, said the trial data were 'very encouraging' but the drug was 'not a panacea' and some patients would need to remain on warfarin.
Professor Fitzmaurice, chair of the Primary Care Anticoagulation Society, added: 'Something you can take once or twice a day that doesn't need monitoring is likely to be very attractive to GPs and could revolutionise our approach to stroke prevention. But there will be a cost implication.'
He said the new GMS contract might have to be updated to include an enhanced service for direct thrombin or stroke prevention clinics.
The latest SPORTIF results were presented at the American Heart Association conference earlier this month. Results from an earlier phase appeared in The Lancet last week.