Data from Pharmawand - Curated by EPG Health - Date added 14 March 2018

Bristol-Myers Squibb Company and Pfizer Inc. will present findings from a real-world data (RWD) analysis titled, Comparison of Effectiveness, Safety, and the Net Clinical Outcome between Different Direct Oral Anticoagulants in 162,707 Non-Valvular Atrial Fibrillation Patients Treated in US Clinical Practice . This is the largest RWD analysis reporting outcomes among different direct oral anticoagulants (DOACs), including Eliquis (apixaban), rivaroxaban and dabigatran, to date.

In this analysis, apixaban use was associated with significantly lower rates of both stroke/systemic embolism (S/SE) (hazard ratio [HR]:0.83, 95% confidence interval [CI]: 0.73 to 0.94, p=0.004) and major bleeding (MB) (HR:0.54, 95% CI: 0.50 to 0.58, p=<0.001) when compared to rivaroxaban; and significantly lower rates of both S/SE (HR:0.69, 95% CI: 0.56 to 0.84, p=<0.001) and MB (HR:0.77, 95% CI: 0.68 to 0.88, p=<0.001) when compared to dabigatran. This retrospective observational analysis utilizing pre-specified endpoints included three 1:1 propensity score individually matched DOAC cohorts: apixaban vs. rivaroxaban (n=125,238), apixaban vs. dabigatran (n=54,192), and dabigatran vs. rivaroxaban (n=55,076). The analysis also revealed that in the dabigatran vs. rivaroxaban cohort, dabigatran was associated with a significantly lower rate of MB (major bleeding) (HR:0.67, 95% CI: 0.60 to 0.74, p=<0.001) and a non-significantly higher rate of S/SE (stroke/systemic embolism ) (HR:1.18, 95% CI: 0.98 to 1.43, p=0.080). It is important to note that, at this time, there are no head-to-head clinical trials comparing DOACs. Anticoagulants, including Eliquis, increase the risk of bleeding and can cause serious, potentially fatal, bleeding.

Study Details : This was a retrospective observational cohort analysis of non-valvular atrial fibrillation (NVAF) patients utilizing pre-specified endpoints and analyzed using propensity-score matching (PSM). It includes NVAF patients (n=162,707) from ARISTOPHANES (Anticoagulants for Reduction In STroke: Observational Pooled analysis on Health outcomes ANd Experience of patientS), an ongoing real-world data analysis initiative that now includes anonymized patient records from more than 300,000 patients. The analysis presented at ACC includes patients who initiated apixaban, rivaroxaban or dabigatran, from Jan. 1, 2013, to Sept. 30, 2015, pooled from 5 large databases, including CMS fee-for-service Medicare data, Truven MarketScan Commercial Claims and Encounter and Medicare Supplemental and Coordination of Benefits Database, the IMS PharMetrics Plus Database, the Optum Clinformatics Data Mart, and the Humana Research Database. After 1:1 DOAC-DOAC PSM in each database, the resulting patient records were pooled. Patients were followed for a mean of six months. Cox models were used to evaluate the rates of S/SE and of MB across DOACs within one year of therapy initiation. Patients with NVAF were included regardless of the dose of DOACs used.

Limitations of Real-World Data Analyses and of ARISTOPHANES : Real-world data have the potential to supplement randomized controlled 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. It is important to note that, at this time, there are no head-to-head clinical trials comparing direct oral anticoagulants. In this analysis, although PSM was used to control for multiple confounders, there is still potential for residual bias. Claims for a filled prescription do not indicate that the medication was consumed or taken as prescribed. Also, medications filled over the counter or provided as samples are not captured in the claims data.


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