Scientific Poster Session III: Systematic Reviews/Meta-Analysis

Systematic Reviews/Meta-Analysis
  Monday, November 13, 2023
  01:00 PM–02:30 PM

Abstract

Background: Direct oral anticoagulants (DOACs) have robust evidence in atrial fibrillation (AF) and venous thromboembolism (VTE). Recent guidance suggests preserved efficacy and safety in obesity. However, DOAC use in this population has not been broadly adopted due to sparse data. While increased body weight (BW) showed modest effects on apixaban’s pharmacokinetics, its efficacy and safety in AF and VTE are not well understood. We conducted a systematic review of published randomized controlled trials (RCTs) and observational studies (real world data (RWD)) to characterize the effects of apixaban in obese patients.

Methods: Using natural language processing (NLP) to text mine PubMed records from January 2021 through June 2023, we identified RCTs and RWD studies comparing apixaban to other OACs, with or without warfarin as an additional comparator, in patients with obesity and comorbid AF or VTE. We then reviewed in detail publications providing BMI or weight categories, which assessed BW’s impact on safety, efficacy, and effectiveness. We excluded duplicates, pooled DOAC analyses, review articles, systematic reviews, metanalyses not reporting apixaban-specific data, preclinical and case studies, commentaries, editorials, and letters. Relative to manual PubMed searches, NLP mitigates the risk of bias.

Results: 238 publications were identified by NLP. 166 were reviewed in detail for inclusion. 40 publications met all inclusion criteria: 11 meta-analyses, 4 RCTs, and 25 RWD studies. No RCT demonstrated an interaction between BW and treatment for efficacy or safety. Similarly, effectiveness and safety in all RWD were consistent across BW groups. Details of these analyses (including BMI > 40 and >50 kg/m2 cohorts) will be presented.

Discussion: RCT and RWD suggest obesity minimally impacts apixaban’s efficacy, effectiveness, and safety in AF or VTE. Apixaban’s benefit-risk profile appears similar in those with and without obesity. Further studies in morbid obesity are needed.

Other: Sponsored by BMS and Pfizer.

Presenting Author

Diem H Chow PharmD
Pfizer

Authors

Wonkyung Byon PhD
Pfizer

Michael J Jamieson MD
Pfizer

Samira J Merali PharmD, MS
Britol Myers Squibb

Joelle Onorato PhD
Bristol Myers Squibb

Andres J Quintero MD, MPH, MBA
Pfizer

Richard W Dettloff PharmD, BCPS
Pfizer