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Findings Released from Largest Real-World Data Analysis of Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants

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2.8 from 11 votes
Monday, March 12, 2018

PRINCETON -Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) will present findings today 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 (HR:0.67, 95% CI: 0.60 to 0.74, p=<0.001) and a non-significantly higher rate of S/SE (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. Please see important safety information below for Eliquis, including BOXED WARNINGS.

"Most observational, real-world data analyses of direct oral anticoagulants have used single data sources; in this analysis, we pooled CMS Medicare data and four U.S. Managed Care claims databases, including both commercial and Medicare Advantage lives, covering in total more than 180 million beneficiaries annually1,2 – more than half of the U.S. population," said Steven Deitelzweig, M.D., System Department Chair of Hospital Medicine, Ochsner Medical Center, New Orleans, and one of the analysis' primary investigators. "Being able to see patient claims from different data sets with good representation across the country may help decision making in clinical practice."

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.

BMS-Pfizer Alliance Real-Word Data (RWD) Program: ARISTOPHANES is part of the Bristol-Myers Squibb-Pfizer Alliance global RWD analysis program, ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program includes retrospective, outcomes-based analyses from over 16 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.

Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.

About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from multiple Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.

About ARISTOTLE
ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.

About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

About Pfizer Inc.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. 

Source: Bristol-Myers Squibb
2.81818181818
2.8 from 11 votes
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