First once-a-day pill for stroke prevention in irregular heartbeat patients
Rivaroxaban will help treat the most common heart rhythm disturbance, artrial fibrillation, affecting around 800,000 (file photo)
The first once-a-day blood-thinning drug in patients with an irregular heartbeat has been approved for use in Britain.
Rivaroxaban works as well as warfarin, a treatment based on rat poison which has been used since the 1950s, and has fewer side effects.
The drug is one of a new generation of anti-clotting agents aimed at preventing strokes and other potentially fatal events suffered by people with atrial fibrillation (AF).
It is the most common heart rhythm disturbance, affecting around 800,000 Britons and causes around one in seven first-time strokes.
In AF the upper chambers of the heart are out of rhythm and beat much faster than normal, which allows blood to pool and generate tiny blood clots which can trigger a stroke.
The once-daily pill has a key advantage over a rival medicine Pradaxa that must be taken twice a day.
Rivaroxaban, which has the brand name Xarelto, is already recommended on the NHS for short-term use to prevent blood clots in people undergoing hip and knee replacement surgery.
It has now been licensed by the European Commission for prevention of stroke in AF patients who would have to take it for life – it was licensed for the same purpose in the US last month.
The drug has also been approved as a one-off treatment for deep vein thrombosis (DVT).
But the NHS rationing body will have to consider whether the NHS can afford it, either as a replacement for warfarin or for patients who cannot take it.
The verdict from Nice, the National Institute for Health and Clinical Excellence, will be delivered in May, but it is preparing to approve Pradaxa for some patients despite an annual cost of 919.
Although rivaroxaban at 2.10 a day is cheaper, there is still a big price differential with warfarin – the new drug costs around 64 for a month’s supply whereas warfarin costs around 1, plus clinic visits.
In atrial fibrillation the upper chambers of the heart are out of rhythm and beat much faster than normal, which allows blood to pool and generate tiny blood clots which can trigger a stroke
Warfarin, which is still used in largedoses to kill vermin, has been given routinely to AF patients for decades, reducing the rate of stroke by up to two-thirds at the cost of increased bleeding.
But it is inconvenient for patients because careful monitoring and regular blood tests are needed to prevent excessive bleeding from cuts or stomach ulcers, requiring frequent clinic visits for INR (international normalised ratio) testing.
It can also interact badly with other drugs, alcohol and certain foods, including green vegetables and grapefruit.
Rivaroxaban could replace Warfarin, an anti-clotting drug, which is used in stronger doses as a rat poison
It is thought warfarin is used by more than 500,000 people, for short-term prevention and treatment of blood clots as well as long-term prevention of strokes in AF patients.
But experts say it is under-used by those who could benefit because of the close monitoring needed to ensure it is safe and effective.
Trudie Lobban, Chief Executive and Founder of the Atrial Fibrillation Association, said ‘The consequences of blood clots can be overwhelming and their prevention and treatment should rightly be considered a health priority.
‘Thrombosis represents a massive burden on patients and the UK health system. Warfarin eligible AF patients, especially those with a higher risk profile and with significant co-morbidities, tend to require more frequent INR testing.
‘These additional tests have a significant impact on these patients’ quality of life as well as on NHS resources, so the approval of new therapies to prevent stroke in atrial fibrillation are welcome.’
The drug was co-developed by Bayer AG and Johnson & Johnson and is expected to make peak sales worth two billion euros a year in Europe.
‘Xarelto represents a step forward in therapies to combat the consequences of blood clots which can be devastating for patients and their families’ said Luis-Felipe Graterol, Medical Director at Bayer Healthcare UK.
‘There has been a long-established need for treatment options which don’t require regular blood monitoring and avoid the potential limitations associated with both warfarin and injectable heparins.’