Data from a late-stage trial show that Bayer and Janssen’s Xarelto was better than aspirin at protecting patients from recurrent venous thromboembolism (VTE).
According to results of the Phase III EINSTEIN CHOICE study, presented at the American College of Cardiology (ACC) 66th Annual Scientific Session in Washington DC and published in the The New England Journal of Medicine, the as yet unapproved 10mg once daily dose of the oral Factor Xa inhibitor cut relative risk of recurrent VTE by 74 percent compared with aspirin 100mg once daily.
On the safety side, among the 3,396 patients rates of major bleeding - a key factor when considering treatment with anticoagulation therapies - was found to be comparable between Xarelto (rivaroxaban) and aspirin.
“At the moment due to a lack of robust clinical evidence many doctors are reluctant to continue anticoagulation therapy for longer durations because of uncertainty around the benefit-risk balance,” said Dr Alexander T. Cohen, principal study investigator, Guys & St Thomas’ Hospitals, Kings College London. “The findings from EINSTEIN CHOICE demonstrate the benefit of prescribing rivaroxaban for the extended treatment of VTE.”
VTE affects around one in every 1,000 people in the UK and each year more than 25,000 people in the country die from it.
“Once approved, rivaroxaban 10mg once daily, alongside the currently approved 20mg once daily, will provide doctors with an additional weapon in their armamentarium in the battle to reduce the risk of recurrent VTEs, alleviating some of the pressure on our hospitals, reducing VTE-related deaths and improving the quality of life for people who have experienced an unprovoked VTE or are living with ongoing risk factors,” Dr Cohen added.
In patients with VTE, anticoagulation therapy is recommended for three months or longer, depending on the balance between the risk of recurrence and the risk of bleeding; the risk for patients with unprovoked VTE or with ongoing risk factors experiencing a second event is up to 10 percent in the first year if treatment is stopped, Bayer noted.
“The threat of a secondary VTE is very real for people who have stopped receiving treatment after three, six or 12 months,” commented Professor Simon Noble, Thrombosis UK. “We welcome the data released today that will enable people who have had an unprovoked VTE, or who are at high risk, to live their lives with more certainty knowing that by receiving extended treatment their risk of a recurrent VTE is significantly reduced.”
Data from the EINSTEIN CHOICE study also showed that Xarelto 20mg once daily (already approved treatment regimen) significantly reduced the relative risk of recurrent VTE by 66 percent compared with aspirin 100mg once daily.
Earlier this year, the bloodthinner showed clear efficacy in preventing major cardiovascular events (MACE) in patients with coronary or peripheral artery disease taking part in the COMPASS trial, prompting an early halt to the late-stage study.
The 27,000-plus patient trial was scheduled to finish next year but has been stopped early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE - including cardiovascular death, myocardial infarction and stroke - reached its pre-specified criteria for superiority versus aspirin.