Credit: CDC
The US Food and Drug Administration (FDA) has approved apixaban (Eliquis) as prophylaxis for deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
Apixaban is already FDA-approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The latest approval is supported by data from 3 trials comprising the ADVANCE clinical trial program.
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.
The prescribing information for apixaban includes a boxed warning detailing the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue the drug without adequate continuous anticoagulation.
The boxed warning also states that, in patients undergoing spinal epidural anesthesia or spinal puncture, apixaban poses an increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis.
The risk of these events may be increased by the use of indwelling epidural catheters for the administration of analgesia or by the concomitant use of drugs affecting hemostasis, such as nonsteroidal anti-inflammatory drugs, platelet aggregation inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.
Healthcare professionals should monitor patients for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.
For more information on adverse events and contraindications, see the full prescribing information for apixaban. The drug is under joint development by Pfizer and Bristol-Myers Squibb.
