• Superior outcomes vs. warfarin, established in ARISTOTLE, are complemented by a wealth of real-world data vs. warfarin — while NOAC vs. NOAC real-world data offer additional evidence to support your prescribing decisions.^​3
  ​

• RWE studies can complement the findings from RCTs, provide valuable information on treatment practices and patient characteristics in a real-world setting, and are essential to the evidence base required for sound coverage and payment decisions.^​4
   

• Analyses from RWD program, ACROPOLIS, use two large U.S. databases to provide insights on Eliquis (apixaban), warfarin, and other direct oral anticoagulants in patients with NVAF at 2017 American Heart Association (AHA) Scientific Sessions.⁵

The utility, strengths and limitations of RWE studies, as well as potential developments to further bridge the gap between RCTs and daily clinical practice.⁴

• RWE studies can complement the findings from RCTs by providing valuable information on treatment practices and patient characteristics among unselected patients. This information is necessary to guide treatment decisions and for reimbursement and payment decisions.^​4
   

• Clinical trials demonstrated promising results in terms of the safety of NOACs relative to VKAs—the ARISTOTLE trial found lower bleeding and mortality rates with apixaban over warfarin.³

*In ARISTOTLE. Eliquis® was studied in a randomized, double blind, double-dummy, non-inferiority trial in 18,201 patients. Stroke/systemic embolism was the primary efficacy endpoint and major bleeding was the primary safety endpoint (defined​ according to ISTH criteria).​

†The definition of efficacy and safety endpoints as well as assessed patient populations may differ across the above studies. Unlike in clinical trial, hazard ratios shown for the real-world analyses adjusted for selected baseline characteristics.^2-​5

‡BEYOND Norway was a real-world analysis of non-valvular AF Patients, with no oral anticoagulant exposure in the last 180 and with a first oral anticoagulant prescription in the study period (1 January 2013—30 June 2015), comparing the rate of bleeding in patients prescribed ELIQUIS. Rivaroxaban, dabigatran or warfarin. The primary endpoint was major or clinically-relevant non-major bleeding, defined as bleeding at key sites requiring hospitalisation with a diagnosis for bleeding (inpatient bleeding). Effectiveness endpoints were not included in the analysis. In BEYOND Norway, 70.8% of Eliquis® patients received the standard dose of 5 mg BD and 29.2% of patients received a reduced dose of 2.5 mg BD.³

§In the independent, US real-world analysis, the primary effectiveness outcome was stroke or systemic embolism, including ischemic stroke, haemorrhagic stroke, and systemic embolism. The primary, safety outcome was major bleeding, including​ gastrointestinal bleeding, intracranial bleeding, and bleeding from other sites. The analysis included outcomes that occurred on treatment, and were identified using ICD-9 codes in the primary or secondary diagnosis positions of inpatient claims. In this US real-world analysis, 81.9% of Eliquis® patients received the Standard dose of 5 mg BD and 18.1% of patients received a reduced dose of Eliquis® 2.5 mg BD.⁴

AF: Atrial Fibrillation; HR: hazard ratio; NOAC: Non-vitamin K antagonist Oral Anticoagulant; RRR: Relative Risk Reduction.​

References: 1. Eliquis 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-992. 3. Halvorsen S, Ghanima W, Fride Tvete I, et al. A nationwide registry study to compare bleeding rates in patients with atrial fibrillation being prescribed oral anticoagulants. Eur Heart J Cardiovasc Pharmacother. 2017;3(1):28-36. 4. Yao X, Abraham NS, Sangaralingham LR, et al. Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2016;5(6). pii: e003725. 5. Li XS, Deitelzweig S, Keshishian A, et al. Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in “real-world” clinical practice. A propensity matched analysis of 76,940 patients. Thromb Haemost. 2017;117(6):1072– 1082. 6. Lip GY, Keshishian A, Kamble S, et al. Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin. A propensity score matched analysis. Thromb Haemost. 2016;116(5):975-986.​

*The analysis included outcomes that occurred on treatment, defined as the time after the first eligible prescription fill until the end of enrolment in health plans, the end of the study period (30 June 2015), discontinuation of treatment or switching to another oral anticoagulant.³

†In the US real-world analysis, the primary effectiveness outcome was stroke or systemic embolism, including ischaemic stroke, haemorrhagic stroke and systemic embolism. The primary safety outcome was major bleeding including GI bleeding, intracranial bleeding, and bleeding from other sites. The analysis included outcomes that occurred on treatment, and were identified using ICD-9 codes in the primary or secondary diagnosis positions of inpatient claims.^​3

OBJECTIVE: To assess the effectiveness and safety of Eliquis®, dabigatran and rivaroxaban for stroke prevention in AF patients, in a large US contemporary evaluation comparing NOACs and warfarin³​

*The analysis included outcomes that occurred on treatment, defined as the time after the first eligible prescription fill until the end of enrolment in health plans, the end of the study period (30 June 2015), discontinuation of treatment or switching to another oral anticoagulant.³

†In the US real-world analysis, the primary effectiveness outcome was stroke or systemic embolism, including ischaemic stroke, haemorrhagic stroke and systemic embolism. The primary safety outcome was major bleeding including GI bleeding, intracranial bleeding, and bleeding from other sites. The analysis included outcomes that occurred on treatment, and were identified using​ ICD-9 codes in the primary or secondary diagnosis positions of inpatient claims.³

*Major bleeding was defined as including GI bleeding, intracranial bleeding, and bleeding from other sites. The analysis included outcomes that occurred on treatment, and were identified using ICD-9 codes in the primary or secondary diagnosis positions of inpatient claims.³

OBJECTIVE: To compare the risk of first major bleeding event leading to hospitalisation in treatment-naïve, NVAF patients receiving Eliquis® or warfarin^3*​

There are no head-to-head clinical trials comparing the NOACs. This analysis compared individual NOACs with Warfarin. Comparisons cannot be made between individual NOACs based on these data.​

*Analysis of effectiveness data was not included in this objective.^​3
†The CCI contains 19 comorbidity categories and predicts the 10-year mortality for a patient who may have a range of comorbid conditions. Higher scores indicate greater comorbidity and a patient with a score >5 has essentially a 100% risk of dying at one year.⁴

The effectiveness and safety of Eliquis® vs. warfarin was assessed in ‘REAL-WORLD’ clinical practice in NVAF patients^​3

There are no head-to-head randomised clinical trials comparing the NOACs. This analysis compared individual NOACs with warfarin. Comparisons cannot be made between Individual NOACs based on these data.​

Adapted from LI X, et al. Thrombosis and Haemostasis. 2017.​