The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) for Xarelto (rivaroxaban).
The approval is for the indication of preventing atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) who are at high risk of ischaemic events, and is approved to be administered at a dose of 2.5 mg twice daily (BID) combined with aspirin (75-100 mg) once daily.
The approval is based on evidence from the COMPASS study, the largest Phase III study involving the drug, which showed that the combination statistically significantly reduced the risk of the composite of cardiovascular (CV) death, stroke or myocardial infarction (MI) by 24%.
The drug in question is an anticoagulant that targets Factor Xa, an enzyme which acts at a key point in the blood clotting process, inhibiting its ability to generate thrombin. Coronary artery disease patients who are at high risk of ischaemic events are defined by NICE as those aged 65 or over, patients with atherosclerosis in at least two vascular territories, or those presenting risk factors such as smoking, diabetes, kidney dysfunction, heart failure or a history of stroke.
“Cardiovascular disease remains the biggest cause of years of life lost in the UK,” reminded Dr Derek Connolly, COMPASS trialist.
He went o to say that “There have been few recent major new advances in the medical management of patients with CAD and PAD to protect them against strokes or heart attacks”
'The COMPASS trial showed that adding rivaroxaban vascular dose (2.5 mg BID) to low-dose aspirin significantly reduced vascular events. The large reduction in events [such as strokes], outweighed the increase in major bleeding events seen.
“Rivaroxaban vascular dose in combination with aspirin is the first treatment of its kind for this patient population and this recommendation from NICE provides clinicians with an important additional option for treating patients at risk of major adverse cardiac events such as CV death, stroke or MI.”
More than seven million people are living with cardiovascular disease in the UK and it is estimated that CVD, including CAD and PAD, is responsible for 170,000 deaths in the UK each year, representing a quarter of all annual deaths.