Up until now, there were no published studies, and limited real-world evidence, on the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients 80 years and older. Now, new research on the topic, presented at the American Heart Association’s Scientific Sessions 2018 in Chicago in November, provides valuable insight.
In the study sponsored by the Bristol-Myers Squibb-Pfizer Alliance, researchers found that, among very elderly patients with nonvalvular atrial fibrillation (NVAF), apixaban (Eliquis) was associated with a lower risk of stroke/systemic embolism (S/SE) and major bleeding (MB) compared to dabigatran (Pradaxa) and rivaroxaban (Xarelto).
Drug Topics spoke with Steven Deitelzweig, MD, one of the lead investigators for the ARISTOPHANES study and system chairman of hospital medicine and associate professor of medicine at Ochsner Clinical School in New Orleans about the novel research.
DT: Is this a first-of-its-kind study? Is it rare that NOACs are studied in very elderly patients?
Deitelzweig: Yes, very elderly patients have been under-represented in randomized clinical trials and there are no head-to-head randomized controlled trials with direct comparisons between NOACs. In addition, limited evidence exists on the effectiveness and safety of NOACs in this population, which leaves practicing physicians such as myself making treatment decisions without population-specific clinical trial data, underscoring the importance of real-world evidence in filling these information gaps.
Studies such as ARISTOPHANES aim to provide clearer understanding of the effectiveness and safety associated with a treatment option in routine clinical practice. To date, ARISTOPHANES, is the largest real-world data study evaluating oral anticoagulants among patients with NVAF, including NVAF patients aged 80 and older.
DT: Why is this research important? How will it help pharmacists and physicians?
Deitelzweig: Under-treatment with anticoagulants is frequently seen among elderly populations, perhaps due to fear of increased bleeding risks that accompany aging. The analysis of real-world data provides the opportunity to analyze anonymized historical data from this patient population and make informed inferences in lieu of data for patients 80 years of age and older with NVAF.
These results may be helpful for clinicians in evaluating the risk-benefit ratio of NOACs for elderly NVAF patients and help fill information gaps.
Drug Topics: Have results similar to the ones you found been verified in other studies?
Deitelzweig: Yes, these data are consistent with findings from the pivotal Phase 3 ARISTOTLE clinical trial, which compared the effects of apixaban versus warfarin on the risk of stroke and systemic embolism in patients with NVAF. Patients included in this study were aged 75 years or older. Results of the study showed that in patients with NVAF, apixaban was superior to warfarin in preventing stroke/systemic embolism and major bleeding.
Drug Topics: What else is important to know about this research?
Deitelzweig: It is important for prescribers to note that, while real-world data cannot replace randomized clinical trials, they can complement clinical trial data by painting a fuller picture of a treatment option. In recent years, methodologies for analyzing real-world data have evolved, allowing for greater rigor and transparency when assessing analyses.
The fact that this real-world data sub-analysis of the ARISTOPHANES study was selected by AHA as an oral presentation underscores the increasing importance that medical professionals are placing on this type of research to help inform treatment decisions.