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NEW ORAL ANTICOAGULANTS No NEW ORAL ANTICOAGULANTS No. 20, Oct 2012 Produced by NHS Greater Glasgow and Clyde Medicines Information Service . There are three new oral anticoagulants licensed Rivaroxaban Dabigatran Apixaban in the UK, rivaroxaban, dabigatran and apixaban. All three agents are licensed for the prevention of Prevention of On total Non- Non- venous thromboembolism (VTE) in hip and knee VTE following Formulary Formulary Formulary replacement surgery. Rivaroxaban is the only hip or knee with agent on the total Formulary for this indication. replacement restrictions . Rivaroxaban and dabigatran are licensed for the surgery prevention of stroke and systemic embolism in Prevention of On total On total _ patients with atrial fibrillation (AF). Both are on stroke and Formulary Formulary the total Formulary for this indication with systemic with with restrictions. embolism in restrictions restrictions . In AF, preference of rivaroxaban or dabigatran AF over warfarin for practical rather than clinical Treatment of On total reasons is non-Formulary. DVT and Formulary _ _ . Rivaroxaban is also licensed for the treatment of prevention of with deep vein thrombosis (DVT) and prevention of recurrent DVT restrictions recurrent DVT/pulmonary embolism (PE). It is on and PE the total Formulary as an alternative to warfarin when the intended treatment duration is 3 to 6 NB. New indications for these agents are at months. different stages of development and therefore they may be licensed for additional indications in the Introduction near future. There are three new oral anticoagulants licensed in the UK. The direct thrombin inhibitor, dabigatran and the two direct factor Xa inhibitors, rivaroxaban and apixaban.1 Apixaban is Evidence non-Formulary and should not routinely be prescribed in Prevention of VTE following hip and knee 2 NHS Greater Glasgow & Clyde (NHSGGC). Rivaroxaban replacement surgery and dabigatran are on the Formulary for specific indications Rivaroxaban is on the total Formulary.2 Dabigatran and and should only be prescribed according to the Formulary apixaban are non-Formulary for this indication because 2 restrictions. the formulary decision was that the medicines do not represent sufficient added benefit to rivaroxaban, which is What are the new oral anticoagulants licensed for? already on the Formulary.2 Dabigatran is the only oral direct thrombin inhibitor 1 currently licensed in the UK. It is licensed for the primary What is the evidence for the use of rivaroxaban for prevention of venous thromboembolic events in adult the prevention of VTE following hip and knee patients who have undergone elective total hip replacement surgery? replacement surgery (THR) or total knee replacement 3,4 Rivaroxaban has only been compared with enoxaparin for surgery (TKR). It is also licensed for the prevention of this indication. Three randomised, placebo-controlled, stroke and systemic embolism in adult patients with double-blind phase III studies compared rivaroxaban 10 nonvalvular atrial fibrillation (AF) with one or more risk mg orally once a day with subcutaneous enoxaparin 40 mg factors (refer to manufacturer's summary of product 10-12 4,5 per day (RECORD 1,2,3). The RECORD study characteristics (SPC) for further information). programme involved over 12,500 patients. RECORD 1 and Rivaroxaban is one of two oral direct factor Xa inhibitors 10,11 1 2 included patients undergoing elective THR surgery currently licensed in the UK. Rivaroxaban is licensed for and RECORD 3 included patients undergoing elective TKR the prevention of VTE in adult patients undergoing elective 12 6 surgery. The primary efficacy outcome in all three studies THR or TKR. It is also licensed for the prevention of was the composite of any DVT (symptomatic or stroke and systemic embolism in adult patients with non- asymptomatic), non fatal PE and all-cause mortality. The valvular AF with one or more risk factors (refer to SPC for primary safety outcome was the incidence of major further information) and for the treatment of deep vein bleeding beginning after the first dose and up to 2 days thrombosis (DVT), and prevention of recurrent DVT and after the last dose of the study drug (on-treatment period). pulmonary embolism (PE) following an acute DVT in 7,8 The studies show that rivaroxaban 10 mg per day was adults. superior to enoxaparin 40 mg daily for the prevention of Apixaban is the other oral direct factor Xa inhibitor 1 VTE in patients following THR or TKR and did not show any currently licensed in the UK. It is licensed for the statistically significant difference in bleeding risk. Refer to prevention of VTE in adults who have undergone elective 13 9 2 PostScript Extra No. 15 for more information. THR or TKR. It is non-Formulary in NHSGGC. 1 What is the evidence for the use of dabigatran for a gastrointestinal (GI) site occurred more frequently in the the prevention of VTE following hip and knee rivaroxaban group (3.2% vs. 2.2%, p<0.001). The rate of replacement surgery? adverse effects were similar, except for epistaxis which Dabigatran has only been compared with enoxaparin for occurred more frequently in the rivaroxaban group. this indication. Dabigatran was shown to be non-inferior to Patients were only followed up for two years, therefore the enoxaparin for the prevention of VTE after THR and TKR long term safety of rivaroxaban is unclear from this study. surgery in the RE-NOVATE14 (n=3494) and RE-MODEL15 (n=2076) studies respectively. Patients were randomised to What is the evidence for the use of dabigatran for either dabigatran 150 mg or 220 mg once daily or the prevention of stroke and systemic embolism in enoxaparin 40 mg once daily. Both doses of dabigatran AF? were shown to be non-inferior to enoxaparin for the Dabigatran has only been compared with warfarin for this primary efficacy outcome (a composite of total VTE indication. Dabigatran 150 mg BD was shown to be (venographic or symptomatic) and mortality) during superior to dose adjusted warfarin for the prevention of treatment in both studies. There was no statistically stroke or systemic embolism in patients with AF in the RE- significant difference in the primary safety outcome of LY study.19 Patients (n=18113) with AF with at least one bleeding rates between either dose of dabigatran and other risk factor for stroke were randomised in a blinded enoxaparin in either trial. fashion to either dabigatran 110 mg or 150 mg twice daily (BD) or open label, adjusted dose warfarin (to maintain an What is the evidence for the use of apixaban for the INR of 2-3). Patients were followed up for a median prevention of VTE following hip and knee duration of two years. The primary outcome of stroke or replacement surgery? systemic embolism was 1.69% per year in the warfarin Apixaban has only been compared with enoxaparin for this group, as compared with 1.53% per year in the group that indication. Apixaban was shown to be similar to enoxaparin received dabigatran 110 mg BD (relative risk with for the prevention of VTE after TKR and THR surgery in the dabigatran, 0.91, 95%CI 0.74-1.11, p<0.001 for non- ADVANCE-216 (n=3057) and ADVANCE-317 (n=5407) inferiority) and 1.11% per year in the group that received studies respectively. Patients were randomly allocated to dabigatran 150 mg BD (relative risk, 0.66, 95%CI 0.53- receive apixaban 2.5 mg twice daily or enoxaparin 40 mg 0.82, p<0.001 for superiority). Therefore, dabigatran 110 once daily. Apixaban was shown to be superior to mg BD was non-inferior to warfarin and dabigatran 150 mg enoxaparin for the primary outcome, a composite of BD was superior to warfarin for the prevention of stroke asymptomatic or symptomatic DVT, non-fatal PE, and all- and systemic embolism. cause mortality during treatment, in both studies. There was no statistically significant difference in the The primary safety outcome of major bleeding was lower in primary safety outcome of major or clinically relevant non- patients on the lower dose of dabigatran 110 mg BD major bleeding between apixaban and enoxaparin in either compared to warfarin and was similar to warfarin in study. patients receiving dabigatran 150 mg BD (3.36% per year warfarin versus 2.71% dabigatran 110 mg BD (p=0.003) Prevention of stroke and systemic embolism in and 3.11% dabigatran 150 mg BD group (p=0.31)). AF Although the rate of major bleeding was similar with What is the evidence for the use of rivaroxaban for dabigatran 150 mg BD and warfarin, there was a the prevention of stroke and systemic embolism in significantly higher rate of GI bleeding with dabigatran 150 AF? mg BD. Rates of intracranial bleeding were significantly Rivaroxaban has only been compared with warfarin for this higher in the warfarin group compared to either dose of indication. Rivaroxaban was shown to be non-inferior to dabigatran. warfarin for the prevention of the primary outcome of stroke and systemic embolism in patients with AF in the In addition to the increased rate of GI bleeding, dabigatran double blind ROCKET-AF (n=14264) study.18 The study was also associated with an increased risk of dyspepsia primarily assessed the non-inferiority of rivaroxaban to compared to warfarin. It has been suggested that the GI warfarin and if non-inferiority was confirmed, tests for effects may be due to acidity from the tartaric acid core of superiority were performed. Patients with nonvalvular AF at the dabigatran capsules and may have also contributed to moderate to high risk of stroke were randomised to receive the higher discontinuation rates of study drug in the rivaroxaban 15 mg or 20 mg per day (depending on dabigatran groups.
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