Bayer’s Xarelto combo greenlighted by NICE for reducing CV events in artery disease
pharmafile | August 1, 2019 | News story | Sales and Marketing | NHS, NICE, UK, Xarelto, cardiovascular disease, pharma
NICE has awarded final appraisal recommendation to Bayer’s Xarelto (rivaroxaban) at a dosage of 2.5mg twice daily in combination with aspirin 75-100mg once daily 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 UK watchdog took the decision based on results from the largest Phase 3 study undertaken into the efficacy of the drug, encompassing 27,395 patients. The findings showed that the combination reduced the risk of major adverse cardiovascular events (MACE), including cardiovascular (CV) death, stroke or myocardial infarction (MI), by 24% compared to aspirin 100mg once daily alone in patients with stable atherosclerotic vascular disease. The combo also lowered the number of MACE in patients with CAD and PAD.
The therapy will now be made available to patients on the NHS, following approval from the European Commission in April 2018.
“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 CAD and PAD to protect them against strokes or heart attacks,” explained Dr Derek Connolly, Consultant Interventional Cardiologist and Honorary Senior Clinical Lecturer at Birmingham City Hospital, as well as a trialist on the study. “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.
“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,” he added.
Matt Fellows
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