- Medical Updates

The findings from a real-world data analysis of the U.S. Humana database, in which treatment with Apixaban ( Eliquis ) was associated with a significantly lower risk of stroke / systemic embolism and lower rates of major bleeding compared to Warfarin ( Coumadin ) in patients aged 65 years and older with non-valvular atrial fibrillation ( NVAF ) were presented at the ESC ( European Society of Cardiology ) Congress 2017 in Barcelona, Spain.
The Humana database includes managed care medical and pharmacy claims from greater than 20 million persons primarily residing in the Southern and Midwestern regions of the U.S.
This analysis was also published in the journal Current Medical Research and Opinion.

In this observational, real-world data analysis, NVAF patients with U.S. Medicare Advantage insurance were identified in the Humana database by age ( 65 years and older ), and having a pharmacy claim of Apixaban or Warfarin between January 1, 2013, and September 30, 2015.
The analysis evaluated rates of stroke / systemic embolism ( including ischemic stroke, hemorrhagic stroke and systemic embolism ) and major bleeding ( including intracranial hemorrhage, gastrointestinal bleeding, and other major bleeding ).
Rates of stroke / systemic embolism and major bleeding were evaluated in the follow-up, based on hospitalization claims with the corresponding ICD-9-CM codes at the first position among the diagnosis codes associated with any of the inpatient claims.

Apixaban, in this analysis, was associated with a lower risk of stroke / systemic embolism ( hazard ratio, HR=0.65, 95% confidence interval [ CI ]: 0.51 to 0.83, p=0.001 ) and lower rates of major bleeding ( HR=0.53, 95% CI: 0.45 to 0.63, p=0.001 ) compared to Warfarin.

The mean duration of follow-up was 6.3 months for Apixaban and 8.3 months for Warfarin.

People aged 65 and older with non-valvular atrial fibrillation are approximately three to five times more likely to have a stroke than those without this disorder.

In addition to the Apixaban cohort, this observational, retrospective analysis of the Humana database included two other direct oral anticoagulants ( Rivaroxaban [ Xarelto ] and Dabigatran [ Pradaxa ] ).
The analysis was conducted in patients aged 65 and older with non-valvular atrial fibrillation who had not received an oral anticoagulant for at least one year.
Patients had to have continuous health plan enrollment with medical and pharmacy benefits for at least 12 months pre-index date.
Patients with claims indicative of diagnoses of valvular heart disease, venous thromboembolism, transient atrial fibrillation, cardiac surgery, hyperthyroidism and thyrotoxicity, or pregnancy during the baseline period were excluded.

In this analysis, 7,107 matched pair patients were identified as treated with Apixaban and Warfarin respectively ( n=14,214 ) after balancing patient characteristics with propensity score matching ( PSM ).

Real-world data have the potential to supplement randomized clinical trial data by providing additional information about how a medicine performs in routine medical practice.
Real-world data analyses have several limitations. For example, the source and type of data used may limit the generalizability of the results and of the endpoints.
Observational real-world studies can only evaluate association and not causality.
Due to these limitations, real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. ( Xagena )

Source: Pfizer, 2017