In a large clinical trial the new oral anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was at least as effective as standard therapy and caused fewer bleeding complications in patients with acute venous thromboembolism. The results of the AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy) trial are being presented on Monday at the annual meeting of the International Society on Thrombosis and Haemostasis in Amsterdam and are being published in the New England Journal of Medicine. (The embargo on the trial was lifted early by the Journal after being broken by Reuters.)
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A new study suggests that extending anticoagulant therapy for an additional year may be beneficial after patients with venous thromboembolism complete their initial course of therapy. The results of AMPLIFY-EXT (Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment) were presented at the annual meeting of the American Society of Hematology meeting in Atlanta and published simultaneously in the New England Journal of Medicine.
After completing a standard anticoagulation regimen for 6-12 months, 2,486 VTE patients were randomized to either placebo or apixaban (2.5 or 5 mg twice daily) for an additional 12 months. At both doses, apixaban treatment was associated with a large reduction in clinical events and no increase in major bleeding events.
The primary endpoint, the composite of death or symptomatic recurrent VTE, was significantly reduced in the apixaban groups, from 11.6% in the placebo group to 3.8% in the low-dose apixaban and 4.2% in the high-dose apixaban groups (p<0.001 for both comparisons).
There were very few major bleeding events: 4 (0.5%) in the placebo group, 2 (0.2%) in the low dose apixaban group and 1 ((0.1%) in the high dose apixaban group. Clinically relevant non-major bleeds occurred in 2.3% of the placebo group, 3% of the low dose apixaban group, and 4.2% of the high dose apixaban group.
The investigators concluded that the results of the study “provide a rationale for continuing anticoagulation therapy” in VTE patients for whom there is uncertainty about the worth of continued anticoagulant therapy. They calculated that 14 patients would need to be treated to prevent one VTE case.
The FDA today expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk of recurrent DVT and PE.
The oral anticoagulant is already approved to reduce the post-surgical risk of DVT and PE after hip and knee replacement surgery and to reduce the risk of stroke in people with atrial fibrillation. The new indication was granted under the FDA’s priority review program.
“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” said Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, in an FDA press release.
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Although venous thromboembolism (VTE) is a serious problem for acutely ill patients in the hospital, a new study published in the New England Journal of Medicine failed to find any improvement in mortality associated with thromboprophylaxis.
Ajay Kakkar and the LIFENOX investigators randomized 8307 acutely ill patients to enoxaparin or placebo for 10 days. All patients wore elastic stockings with graduated compression.
There was no difference in 30 day mortality or major bleeding between the groups:
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