On 13 December, Bristol-Myers Squibb and Pfizer announced the UK availability of apixaban (Eliquis). The oral anticoagulant is a new prescription only treatment option for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and one or more risk factors such as: prior stroke or transient ischaemic attack; age 75 years or older; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).
According to the NHS, atrial fibrillation is the most common heart rhythm disorder thought to cause approximately 12,500 strokes in the UK every year. The National Institute for Health and Clinical Excellence (NICE) estimates that in the UK, 1.2 million people have been diagnosed with AF and the prevalence is believed to be growing (Banach M, et al; Europace 2008 10: 1266–70).
“Atrial fibrillation causes a five-fold increase in stroke risk. AF-related strokes are often more severe and associated with more deaths than non-AF related strokes. For decades, the most commonly used anticoagulant has been warfarin. However, it requires on-going INR monitoring and can have undesirable drug and diet interactions. The availability of more recent medicines such as apixaban adds to the treatment options available to UK physicians,” said John Camm, clinical cardiologist, St George’s Hospital, London, UK.
Apixaban is a tablet taken twice a day at the recommended dose of 5mg (or 2.5mg in selected patients). The anticoagulant is part of the therapeutic class of factor Xa inhibitors and is the only oral anticoagulant with published prospective randomised trials in both a warfarin-unsuitable patient population and a warfarin-suitable patient population (Granger CB, et al; N Engl J Med 2011; 365:981-92 and Connolly SJ et al; N Engl J Med 2011 364(9):806-17).
The new licence is supported by the pivotal ARISTOTLE and AVERROES studies. ARISTOTLE evaluated apixaban vs. warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin, and AVERROES evaluated apixaban vs. aspirin in 5,599 patients with non-valvular AF who were considered unsuitable for warfarin.
“The findings from the ARISTOTLE study are important, it shows a good balance of efficacy and safety with apixaban, in that apixaban has demonstrated both superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding. In addition, ARISTOTLE is the first study to show a significant reduction in all-cause mortality versus warfarin. In this study, apixaban was better tolerated than warfarin, with fewer people stopping treatment.” John McMurray, Institute of Cardiovascular & Medical Sciences, University of Glasgow, UK.
Trudie Lobban, founder and CEO of the Atrial Fibrillation Association, said, “With AF becoming more common in the UK, more patients require anticoagulation to prevent AF-related stroke. Patients being treated with warfarin have to undergo frequent INR monitoring with regular blood tests. Having the choice of effective new treatments which do not require INR monitoring provides the option to tailor therapy to the individual patient. This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”
Apixaban (2.5mg twice a day) is already indicated for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.