Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. The new england journal of medicine 700 n engl j med 368. Amplify ext apixaban after the initial management of pulmonary embolism and deep vein thrombosis with firstline therapyextended treatment was designed to demonstrate the efficacy and safety of eliquis compared to placebo for the prevention of recurrent dvt and pe following six to 12 months of anticoagulant treatment for dvt andor pe. Rivaroxaban or aspirin for extended treatment of venous. Amplify ext, agnelli 20 amplify, agnelli 21 hokusai vte, buller 22 not meeting the criteria for major bleeding 99 9 9 9 9 9 9 9 9 9 9 medical intervention. Patients were eligible for inclusion in the trial if they met the following criteria. In the apixaban for the initial management of pulmonary embolism and deep. The efficacy of apixaban, a factor xa inhibitor like rivaroxaban, had not yet been demonstrated in a large trial. The studies were assessed with the cochrane risk of. Most of the studies on the prevention of thromboembo. Pdf apixaban for the prophylaxis and treatment of deep. Patients with objectively confirmed symptomatic vte who had completed 612 months with warfarin or apixaban were randomized in a doubleblinded fashion to apixaban 2. New data is presented on investigational oral anticoagulant apixaban in acute coronary syndrome patients.
Extended treatment of venous thromboembolism unm hospitalist. Efficacy and safety study of apixaban for extended. Start free trial view, comment, print, and sign pdfs. Pfe today announced results of a prespecified secondary analysis of the eliquis phase 3 amplify ext trial a pixaban after the initial m anagement of p u l monary embol i sm and deep vein thrombosis with f irstline therap y ext ended treatment. Second, in this study and in the previous trial comparing rivaroxaban with placebo for extended treatment of venous thromboembolism, therapy was given for up to 12 months. Apixaban for the treatment and secondary prevention of. The purpose of the apixiban for the initial management of pulmonary embolism and deepvein thrombosis as firstline therapy amplify trial was to determine if apixaban, an oral factor xa inhibitor, would be noninferior to conventional therapy i. Apixaban reduces hospitalizations in patients with venous.
In the einstein studies, approximately 14% of patients had a body weight 100 kg 17, 18. The advance, advance2 and advance3 trials included 3195, 3057 and 5407 patients, respectively 1517,24,25. Trials such as einstein choice 78 and amplifyext 79 have demonstrated. This website is a free of charge service from daiichi sankyo europe gmbh. Only with adobe acrobat reader you can view, sign, collect and track feedback, and share pdfs for free. In the amplify ext clinical trial, eliquis demonstrated superior efficacy with a comparable major bleeding profile vs. Agnelli g1, buller hr, cohen a, curto m, gallus as, johnson m, porcari a, raskob ge, weitz ji. Liu x, thompson j, phatak h, mardekian j, porcari a, johnson m, cohen at1. Background mortality rates, costs, and utilities were obtained from published sources. Qualifying diagnosis for inclusion in the study was dvt in 65% and pe in 35%. Apixaban has also been studied as extended therapy after 6 months of initial therapy of acute vte for the prevention of recurrent vte compared with placebo amplify ext trial.
Apixaban is effective for the prevention of vte after major orthopedic surgery14. Two doses of apixaban were evaluated in the amplify extension trial and the rate of bleeding was lower for apixaban 2. New oral anticoagulants for the treatment of venous. The amplify ext trial in turn was published in 2012, with the participation of 2486 patients. Duration of extended anticoagulation was 6 to 12 months in the einstein and amplify extension studies and 6 months in the resonate trial. Thebasecase analysis where the risk of mb with no treatment is equal to the risk of mb with apixaban treatment observed in the amplify ext trial. The doubleblind amplify and amplify ext randomized controlled trials were used as evidence for approval. The 20 apixaban for the initial management of pulmonary embolism and deepvein thrombosis as firstline therapy amplify trial randomized 5,395 adults with an acute proximal dvt 65% or pe 35% to apixaban or conventional therapy.
Liu x, johnson m, mardekian j, phatak h, thompson j, cohen at. The amplify trial is a 6month trial investigating apixaban compared to enoxaparin plus warfarin in approximately 4,800 patients with acute dvt or pe. The amplify ext trial compared two dosing regimens of apixaban 2. We performed a metaanalysis of randomized trials to assess the clinical bene. Backgroundapixaban, an oral factor xa inhibitor that can be administered in a simple, fixeddose regimen, may be an option for the extended treatment of venous thromboembolism. Explore data for eliquis in vte prophylaxis after hip. The risks of recurrent vte were similar with the lower and higher dose apixaban regimens rr 0. Extended treatment for prevention of recurrent dvt pe. The page includes a summary of phase iii clinical trials, an overview of indications under investigation by the different drugs and helpful services for patients and healthcare professionals.
Amplify ext apixaban after the initial management of pulmonary embolism and deep vein thrombosis with firstline therapyextended treatment, a randomized, doubleblind, multicenter trial, included 2,486 patients with prior vte who had completed 6 to 12 months of anticoagulation treatment for dvt or pe and for whom there was. Efficacy and safety study of apixaban for extended treatment of. Apixaban for extended treatment of venous thromboembolism n engl j med 3 patients were ineligible if they had a contraindication to continued anticoagulant therapy or if they required ongoing anticoagulant therapy, dual antiplatelet therapy, or aspirin at a dose higher than 165 mg daily. And when you want to do more, subscribe to acrobat pro dc. Pfe today announced results from a posthoc early time course subanalysis of the phase 3 amplify apixaban for the initial management of pulmonary embolism and deep vein thrombosis as firstline therapy trial. Costeffectiveness of apixaban versus low molecular weight.
Apixaban was evaluated for longterm prevention of vte in the amplify ext amplify extended treatment trial. The analysis was conducted from the perspective of the united kingdom national health service. Supplementary appendix this appendix has been provided by the authors to give readers additional information about their work. Eliquis apixaban in dvt and pe treatment eliquis uk. Apixaban for extended treatment of venous thromboembolism agnelli g, buller hr, cohen a, et al. Line therapy amplify trial, apixaban was noninferior to enoxaparinwarfarin in preventing recurrent symptomatic venous thromboembolism vte or venous thromboembolismrelated death, with significantly less bleeding. In the amplify study, approximately 72% of the apixaban group weighed 60100 kg and 19% weighed. Backgroundapixaban, an oral factor xa inhibitor that can be administered in a simple, fixeddose regimen, may be an option for the extended treatment.
Request pdf apixaban for extended treatment of venous. Amplifyext an extension of the 20 amplify trial randomized 2,482 patients with vte who have completed 612 months of anticoagulation to apixaban 2. The analysis evaluated clinical and demographic predictors of allcause. The purpose of this study was to compare the net clinical benefits ncb of extended treatment with noacs based on resonate, einstein ext, and amplify ext trial results. Apixaban reduces hospitalizations in patients with venous thromboembolism. Ext trial, which showed that extended anticoagulation with apixaban reduced the risk of all. In this multicenter trial, the oral factor xa inhibitor apixaban was compared with enoxaparin and warfarin for the treatment of acute venous thromboembolism. The amplify ext trial is a 12month trial investigating apixaban compared to placebo. Secondary analysis of amplifyext examining predictors of. The amplify trial was a randomized doubleblind study that compared the ef. The evaluated outcomes included the number of events avoided in a patient cohort, total costs. The goal of the trial was to evaluate treatment with apixaban, a factor xa inhibitor, compared with placebo among patients with venous.
European commission approves eliquis apixaban for the. An analysis of the apixaban for the initial management of pulmonary embolism and deepvein thrombosis as firstline therapy amplify trial. Pfe today announced results of a prespecified secondary analysis of the eliquis phase 3 amplify ext trial apixaban after the initial management of pulmonary embolism and deep vein thrombosis with firstline therapyextended treatment. Final appraisal determination apixaban for the treatment and secondary prevention of deep vein thrombosis andor pulmonary embolism issue date. Amplify posthoc early time course analysis evaluated.
Amplifyext an extension of the 20 amplify trial randomized 2,482 patients with vte who have completed 612 months of anticoagulation. Efficacy and safety study of apixaban for the treatment of. These results are consistent with an analysis from the amplify. The basecase analysis conducted from a healthcare payers perspective.
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