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in the UK.
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ELIQUIS® (apixaban) is indicated for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75 years, hypertension, diabetes mellitus, symptomatic heart failure (NYHA Class ≥II); treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults; and, prevention of venous thromboembolic events (VTE) in patients who have undergone elective hip or knee replacement surgery.
Real-World Data in VTE
The clinical trial programme for ELIQUIS® is supported by real-world data in patients treated for DVT / PE, including over 17,000 ELIQUIS patients from four US claims databases1,2
Real-world analyses provide a broader understanding of patient outcomes beyond the clinical trial setting, offering additional evidence for your prescribing decisions3
What does this mean?
Real-world data complement the results of RCTs by providing additional information for informed treatment decisions.3
Rationale and study overview
In the Weycker et al. 2018 USA retrospective, real-world analysis, investigators assessed the safety and effectiveness outcomes of ELIQUIS vs. parenteral anticoagulant / warfarin in 35,756 patients with acute DVT / PE, using pooled data from four geographically diverse US claims databases.2
Study endpoints included:2
The propensity score-matched cohort design meant ELIQUIS patients were matched to parenteral anticoagulant / warfarin patients based on variables including age, gender, and comorbidities, as well as other factors.2
Confounding errors can be minimised using propensity score matching to account for differences in patient characteristics between treatment groups.
Limitations of real-world data include:3
ELIQUIS has a superior major bleeding profile with comparable efficacy vs. enoxaparin / warfarin for treatment of VTE as demonstrated in the AMPLIFY RCT, and complemented by the results of a real-world analysis1,2*
The definitions of efficacy / effectiveness and safety endpoints, as well as the assessed patient populations, differed between the above studies.
* In the AMPLIFY RCT, the primary efficacy outcome was recurrent symptomatic VTE or death related to VTE.1 In the Weycker et al. real-world analysis, the effectiveness outcome was recurrent VTE.2
† ELIQUIS was compared with subcutaneous enoxaparin and warfarin. Enoxaparin was discontinued when an INR of 2 or more was achieved. The primary safety outcome was adjudicated major bleeding and the secondary safety outcome was the composite of major bleeding and CRNM bleeding. Bleeding was defined as major if it was overt and associated with a decrease in haemoglobin levels of 2 g/dl or more, required transfusion of two or more units of blood, occurred into a critical site, or contributed to death. CRNM bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, contact with a physician, interruption of study drug, or discomfort or impairment in carrying out activities of daily life.1 Primary efficacy outcome was recurrent symptomatic VTE or death related to VTE.1
‡ AMPLIFY results are presented as RR (95% CI), whereas Weycker et al. 2018 real-world analysis results are presented as HR (using shared frailty models [an extension of the Cox proportional hazards model that adjusts for correlation from matching]).1,2
§ ELIQUIS was compared with warfarin plus parenteral anticoagulant bridge therapy (which includes enoxaparin). Major bleeding was defined as an acute-care inpatient admission with a principal or first-listed ICD-9-CM / ICD-10-CM diagnosis code for gastrointestinal bleeding, intracranial haemorrhage or other selected types / sites of bleeding, or an ICD-9-CM / ICD-10-CM procedure code for the treatment of bleeding.2 CRNM bleeding was defined as an acute-care inpatient admission with a secondary diagnosis code or an ambulatory care encounter with a diagnosis code for gastrointestinal bleeding or other non-critical care types / sites of bleeding. Events that met the definitions for both major bleeding and CRNM bleeding were classified as major bleeding; CRNM bleeding events that followed major bleeding events were not considered in analyses of CRNM bleeding.2 Recurrent VTE was defined as a subsequent acute-care inpatient admission with a corresponding principal / first-listed diagnosis. Admissions occurring within 7 days of the index VTE encounter – irrespective of care setting – were not considered as recurrent events.2
CI = Confidence Interval CRNM = Clinically Relevant Non-Major DOAC = Direct-acting Oral Anticoagulant DVT = Deep Vein Thrombosis
HR = Hazard Ratio
ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification ICD-10-CM = International Classification of Disease, Tenth Revision, Clinical Modification INR = International Normalised Ratio N = Total number of patients in the ELIQUIS group or the enoxaparin / warfarin group n = Number of patients with event PE = Pulmonary Embolism RCT = Randomised Controlled Trial RR = Relative Risk RWD = Real-World Data VTE = Venous Thromboembolism