Credit: Andre E.X. Brown
Health Canada has expanded the indication for the oral anticoagulant apixaban (Eliquis).
The direct factor Xa inhibitor can now be used to prevent venous thromboembolism (VTE) in adult patients who have undergone elective total hip surgery or knee replacement surgery.
The drug was already approved in Canada to treat and prevent recurrent VTE and for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
“The development of VTE or pulmonary embolism is an important risk for patients having major orthopedic surgery such as total knee or hip replacement,” said John Eikelboom, MBBS, of McMaster University in Hamilton, Ontario.
“The approval of apixaban gives Canadian surgeons a new option to help prevent VTE in these patients. As an oral option for patients in hospital and once they return home after surgery, where most clotting complications can take place after they are discharged from hospital, apixaban offers patients an alternative to an injected anticoagulant.”
Health Canada’s approval of apixaban is based on results of the ADVANCE clinical trials. In these trials, researchers randomized 11,659 patients and assessed the efficacy and safety of apixaban compared to enoxaparin.
The primary efficacy endpoint of the trials was the composite of asymptomatic and symptomatic deep vein thrombosis (DVT), nonfatal pulmonary embolism (PE), and death from any cause during study treatment. The principal safety measure was the composite of major and clinically relevant nonmajor bleeding.
Results of the first ADVANCE study suggested apixaban was roughly as effective as enoxaparin at preventing DVT and PE in patients who had undergone total knee replacement surgery. But apixaban posed a significantly lower risk of major and nonmajor bleeding.
The ADVANCE-2 study, on the other hand, indicated that apixaban was a more effective means of thromboprophylaxis than enoxaparin in this patient population. And there was no significant difference between the treatment arms in the frequency of major or clinically relevant bleeding.
The ADVANCE-3 study suggested apixaban was more effective than enoxaparin in preventing DVT and PE among patients undergoing hip replacement. And there was no significant difference between the groups with regard to major or clinically relevant bleeding.
Apixaban is under development in Canada by Bristol-Myers Squibb and Pfizer Canada Inc. For more details on the drug, see the product monograph.
