A new phase III trial shows that Bayer and Janssen’s novel oral anticoagulant (NOAC) Xarelto is more effective than aspirin at preventing recurrent blood clots, with no increase in bleeding risk.
The results of the EINSTEIN CHOICE trial looked at the value of extended treatment of patients with venous thromboembolism (VTE). It’s already known that after an initial few months of anticoagulant treatment for VTE, giving aspirin as a maintenance therapy reduces the risk of recurrence. The new trial results now show – for the first time – that a NOAC is even more effective.
The trial compared Xarelto (rivaroxaban) at a dose of 10mg or 20mg daily with the standard maintenance dose of aspirin (100mg) in VTE patients who had completed six to 12 months of anticoagulation therapy.
After around one year of follow-ups, Xarelto reduced the risk of a recurrent blood clot by 74% for the 10mg dose and 66% for the 20mg dose compared to aspirin, with no difference in serious bleed rates between the groups. The results were presented at the American College of Cardiology (ACC) meeting in Washington DC by Philip Wells of the University of Ottawa and was simultaneously published in the New England Journal of Medicine.
Janssen’s parent company Johnson & Johnson (J&J) said in a statement that up to 10% of people who have suffered a VTE (usually a deep vein thrombosis or pulmonary embolism) go onto have a second clot within a year of stopping treatment. The rate increases to one in five patients within three years.
While clinical guidelines already recommend treatment with an anticoagulant for three months or longer, EINSTEIN CHOICE gives a clear indication of the benefit of extended treatment.
“How best to extend anticoagulant use beyond the initial treatment window has been a constant source of debate, with physicians carefully balancing patients’ risk of another VTE with the risk of anticoagulant-related bleeding,” said Wells.
“These important results have the potential to trigger a paradigm shift in how physicians manage their patients and protect them from VTE recurrence over the long term.”
The results could therefore provide a boost to the position in the NOAC market held by Xarelto, which according to IMS Health figures had 46.5% of the market ahead of rival NOAC Eliquis (apixaban) from Pfizer and Bristol-Myers Squibb (BMS) with 42.5%, well ahead of third place Pradaxa (dabigatran) from Boehringer Ingelheim and Daiichi Sankyo’s new entrant Savaysa (edoxaban).
Xarelto has slipped from a 60%-plus market share, however, with Eliquis gaining ground in part because of a debate about Xarelto’s role in stroke prevention and the design of the pivotal ROCKET-AF study, although that issue now seems to have been laid to rest with the EU and US regulatory affirming the validity of the trial.
Meanwhile, the overall NOAC market is growing strongly in the face of a string of new studies showing the new drugs’ benefits over older anticoagulants such as warfarin.