This promotional information is intended for healthcare professionals based
in the UK.
If you are not a healthcare professional in the UK, click here.
For Prescribing and Adverse Event reporting information, click here.
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.
NVAF – Real World Data
ELIQUIS® (apixaban) RCT results, complemented by real-world evidence1,2
Real-world evidence complements RCTs by providing key insights into diverse clinical settings and patient populations3–5
Summary of differences between clinical trials vs. real-world studies5
RCTs are the ‘gold standard’ for determining the efficacy and safety of a medicine, while real-world evidence can provide insight into the effectiveness in routine clinical practice – together, these can support treatment decisions3–5
Rationale and study overview
ARISTOPHANES was a large-scale retrospective, US real-world analysis examining both DOAC vs. warfarin, and DOAC vs. DOAC in 434,046 propensity score-matched patients with NVAF.2
What are the limitations of the ARISTOPHANES real-world analysis?2
ELIQUIS was associated with a reduced risk of stroke / systemic embolism and a favourable bleeding profile vs. warfarin in real-world settings2
There are no head-to-head RCTs comparing the DOACs.
As ARISTOTLE is a clinical trial and ARISTOPHANES is a real-world analysis, the two studies cannot be directly compared.
The results of the ARISTOPHANES real-world analysis should only be used for hypothesis generation and must be interpreted with caution, as the effectiveness and safety outcomes and assessed patient populations may be different to those in the ARISTOTLE clinical trial.
Additional real-world data studies are available. Please click GET IN TOUCH to contact your local BMS / Pfizer representative for more information.
* End date was selected as it was the last date before the US moved from ICD-9 codes to ICD-10 codes.† Due to this coding switch, it is believed that the researchers wanted to keep the outcome definitions consistent.
† Data in this study were pooled from the US Centres for Medicare and Medicaid Services Medicare data, and 4 commercial claims databases in the US: Truven MarketScan®, IMS PharmMetrics Plus™, Optum® Clinformatics® Data Mart, and the Humana Research Database.2 Though commercial datasets may contain duplicate patient records when pooled, the number of duplicate is likely to be small (~0.5%) and therefore unlikely to affect the results.8
‡ Outcomes were based on hospitalisations with stroke / systemic embolism as the principal or first-listed diagnosis.2
§ Patients were matched 1:1 in each dataset, using propensity scores generated by logistic regression based on demographics, CCI score, baseline bleeding and stroke / systemic embolism history, comorbidities, and baseline co-medications.2
¶ The ARISTOTLE clinical trial was a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients with NVAF and at least one other risk factor for stroke. Stroke / systemic embolism, including haemorrhagic, ischaemic or undetermined stroke, was the primary efficacy endpoint, major bleeding according to ISTH criteria was the primary safety outcome and all-cause mortality was a key secondary endpoint.1 Pre-specified hierarchical sequential testing was performed first on stroke / systemic embolism (primary efficacy endpoint) for non-inferiority, then for superiority, then on major bleeding, and finally, on death from any cause (secondary endpoint).1
# In the ARISTOPHANES retrospective, US real-world analysis, the primary effectiveness outcome was time to first stroke / systemic embolism, including ischaemic stroke, haemorrhagic stroke, and systemic embolism. The primary safety outcome was time to first major bleed, including gastrointestinal bleeding, intracranial bleeding, and bleeding from other sites.2 Outcomes were based on hospitalisations with stroke / systemic embolism or major bleeding listed as the principal or first-listed diagnosis, as identified using ICD-9 codes.2
** After propensity score matching in the ARISTOPHANES retrospective, US real-world analysis, (ELIQUIS vs. warfarin), 75.4% of ELIQUIS patients received the standard dose of ELIQUIS 5 mg BD and 24.6% of patients received a reduced dose of ELIQUIS 2.5 mg BD.2
BD = Twice Daily CCI = Charlson Comorbidity Index CI = Confidence Interval
DOAC = Direct-acting Oral Anticoagulant HR = Hazard Ratio GI = Gastrointestinal ICH = Intracerebral Haemorrhage ICD-9 = International Classification of Diseases, Ninth Revision INR = International Normalised Ratio ISTH = International Society on Thrombosis and Haemostasis N = Total number of patients in either the ELIQUIS group or the warfarin group n = Number of patients with event NVAF = Non-Valvular Atrial Fibrillation OAC = Oral Anticoagulant
RCT = Randomised Controlled Trial RWE = Real-World Evidence