Bayer’s prescription blood thinner Xarelto (rivaroxaban) has received a positive opinion from the National Institute for Health and Care Excellence (NICE).
The recommendation is for a dose of 2.5 mg twice daily (BID) combined with aspirin (75-100 mg), once a day as an option for 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.
The decision is based on evidence from the COMPASS study, the largest Phase III study with Xarelto, which was stopped early after meeting its primary efficacy endpoint. During a mean follow-up of 23 months, fewer patients had strokes in the Xarelto group than in the aspirin group (83 versus 142) and ischemic/uncertain strokes were reduced by nearly half (68 versus 132 per year) by the combination in comparison with aspirin.
Dr Derek Connolly, COMPASS trialist and consultant interventional cardiologist said that ““Cardiovascular disease remains the biggest cause of years of life lost in the UK. There have been few recent major new advances in the medical management of patients with coronary artery disease [CAD] and peripheral arterial [PAD] to protect them against strokes or heart attacks”
He continued, “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. Conducted in more than 30 countries, including the UK, COMPASS was one of the largest ever trials of oral anti-thrombotic therapy providing robust results, overall, and particularly for key patient subgroups at high-risk of recurrent events such as those with renal dysfunction or stable ‘mild’ heart failure.”
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.