Evidence in long-term prevention of VTE recurrence
Click here to view ELIQUIS® (apixaban) prescribing and adverse event reporting information.
Please watch the video below for a discussion on DOACs for the extended treatment of VTE
For extended therapy (prevention of recurrent VTE)
The randomised controlled trials assessing the efficacy and safety of DOACs for extended therapy (prevention of recurrent VTE) are summarised below.1-5
*Only the 2.5 mg BD dose of apixaban is licensed for prevention of recurrent DVT or PE.1
† Edoxaban is approved for the treatment of VTE and prevention of recurrent VTE.6
In the AMPLIFY-EXT clinical trial, in patients who had received 6–12 months of treatment with apixaban or another anticoagulant without recurrence, or had participated in the AMPLIFY clinical trial, and for whom there was clinical equipoise about the continuation or cessation of anticoagulation therapy at 12 months, apixaban 2.5 mg BD:1,5*
significantly reduced the risk of recurrent VTE or all-cause death vs. placebo
demonstrated no significant difference in the rates of both major and major / CRNM bleeding vs. placebo
Adapted from the ELIQUIS smPC1 and Agnelli et al. 2013.5 The AMPLIFY-EXT clinical trial was a 12 month, randomised, double-blind trial in 2,482 patients with VTE who had been treated for 6-12 months with standard anticoagulation therapy or had completed treatment with apixaban or enoxaparin / warfarin as participants in the AMPLIFY trial and for whom there was clinical uncertainty about the benefit of continuing treatment.1,5
* The primary efficacy endpoint was the composite of symptomatic recurrent VTE or death from any cause – an outcome consistent with that recommended in regulatory guidelines for trials of extended treatment for venous thromboembolic diseases.5
† The primary safety endpoint was major bleeding and the secondary safety endpoint was the composite of major or CRNM bleeding events.5
Not all patients who start on apixaban for acute DVT / PE will stay on apixaban; some acute DVT / PE patients who receive treatment do not require treatment for the prevention of recurrent DVT / PE. Other patients may be prescribed apixaban for the prevention of recurrent DVT after initial treatment for acute DVT / PE with another anticoagulant.1 This is an assessment for the prescribing clinician together with patient involvement.
Apixaban should be used with caution in patients with severe renal impairment (CrCl 15–29 ml/min) for the treatment of DVT or PE and prevention of recurrent DVT or PE.1
Apixaban is not recommended in patients with CrCl <15 ml/min, or in patients undergoing dialysis.1
Patients with active cancer can be at high risk of both venous thromboembolism and bleeding events. When apixaban is considered for DVT or PE treatment in cancer patients, a careful assessment of the benefits against the risks should be made.1
Apixaban is not recommended in patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.1
Adverse events should be reported. Reporting forms and information can be found via United Kingdom – The yellow card scheme at www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Bristol-Myers Squibb via firstname.lastname@example.org or 0800 731 1736 (United Kingdom).
ARR=Absolute Risk ReductionBD=Twice DailyCrCl=Creatinine ClearanceCRNM=Clinically Relevant Non-MajorDOAC=Direct-acting Oral AnticoagulantDVT=Deep Vein ThrombosisMHRA=Medicines and Healthcare products and Regulatory AgencyNICE=National Institute for Health and Care ExcellenceOD=Once DailyPE=Pulmonary EmbolismRCT=Randomised Controlled TrialRR=Relative RiskRRR=Relative Risk ReductionsmPC=Summary of Product CharacteristicsVTE=Venous Thromboembolism
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