Following new European Commission approvals, Bayer's Xarelto (rivaroxaban) is now available for use in the UK for two new indications - the prevention of non-valvular atrial fibrillation-related stroke, and for systemic embolism and treatment of deep vein thrombosis (DVT).
Xarelto thus becomes the first once-daily, fixed-dose preventative treatment for UK patients with non-valvular AF at risk of the consequences of stroke, without the need for routine coagulation monitoring. And for the treatment of DVT and prevention of recurrent DVT and pulmonary embolism (PE) in adult patients following an acute DVT, it is "the first and only anticoagulant to offer patients and the NHS a convenient and cost-effective single-drug solution," says Bayer.
Xarelto, a non-vitamin K antagonist (VKA), will be made available at a retail list price of £2.10 per tablet across both indications, it adds.
AF is the most common sustained cardiac rhythm disorder, affecting 750,000 people in the UK. It carries a five-fold increase in the risk of stroke, the effects of which can be devastating and include severe disability and death. Guidelines recommend oral anticoagulants for the majority of AF patients to prevent stroke, but warfarin limitations challenge both healthcare professionals and patients, and the National Institute for Health and Clinical Excellence (NICE) estimates that 46% of patients who should be on warfarin are not receiving it. These patients need to be protected, says the firm.
Also, every year in England more than 25,000 people die from DVT contracted in hospital. This potentially life-threatening condition is also a major cause of morbidity; over 60% of patients with proximal symptomatic DVT develop Post Thrombotic Syndrome. The total cost to the NHS, both direct and indirect, of managing DVT and PE is estimated at £640 million.
Xarelto is the first in a class of non-VKA anticoagulants called Factor Xa inhibitors, which act at a critical point in the coagulation process to prevent clot formation. Their features include predictable anticoagulant effects, convenient oral dosing and a lower risk of drug-drug interactions compared with VKA antagonists such as warfarin. They also do not require frequent dose adjustments, routine anticoagulation monitoring or regular renal monitoring.
"The consequences of blood clots can be overwhelming and their prevention and treatment should rightly be considered a health priority," says Trudie Lobban MBE, chief executive and founder of the Atrial Fibrillation Association (AFA).
"Thrombosis represents a massive burden on patients and the UK health system. VKA-eligible AF patients, especially those with a higher risk profile and with significant co-morbidities, tend to require more frequent international normalised ratio (INR) testing. The additional tests have a significant impact on these patients' quality of life as well as on NHS resources, so the approval of new therapy alternatives that are easier to manage than traditional treatments are welcome," she added.
"Antithrombotic medicine is a fast-evolving area in which we are continually improving our understanding of how to combat blood clots," commented Keith Fox, professor of cardiology at the University of Edinburgh. "Treatments which act at a key point in the blood-clotting process are now emerging as an important therapy option in both short- and long-term clinical settings, and have the potential to help re-shape clinical practice," he said.
Xarelto is already available in the UK to help prevent VTE in patients undergoing elective total hip or knee replacement surgery.