Trial reportBritish journal of clinical pharmacology2013
Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects.
Trial report in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
106 citing papers in PubMed, 8 syntheses or guidelines pooled it, 269 citations in OpenAlex.
- Effects of Bariatric Surgery on the Pharmacokinetics of Cardiovascular Drugs: A Systematic Review and Meta-Analysis.Obesity surgery · 2026Pooled it
- Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Low Body Weight Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis.Cardiovascular drugs and therapy · 2025Pooled it
- Pooled it
- Safety and Efficacy of Rivaroxaban and Apixaban in Patients with Increased Body Mass: a Systematic Review.Clinical drug investigation · 2021Pooled it
- Comparative effectiveness and safety of direct oral anticoagulants compared to warfarin in morbidly obese patients with acute venous thromboembolism: systematic review and a meta-analysis.Journal of thrombosis and thrombolysis · 2021Pooled it
- Drug interactions with apixaban: A systematic review of the literature and an analysis of VigiBase, the World Health Organization database of spontaneous safety reports.Pharmacology research & perspectives · 2020Pooled it
- The non-vitamin K antagonist oral anticoagulants (NOACs) and extremes of body weight-a systematic literature review.Clinical research in cardiology : official journal of the German Cardiac Society · 2017Pooled it
- Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH.Journal of thrombosis and haemostasis : JTH · 2016Guideline
- Apixaban in Japanese patients with cancer-associated venous thromboembolism: a multi-center phase II trial.International journal of hematology · 2022Trial
- Population Pharmacokinetics, Pharmacodynamics, and Exploratory Exposure-Response Analyses of Apixaban in Subjects Treated for Venous Thromboembolism.CPT: pharmacometrics & systems pharmacology · 2017Trial
- Risk-Stratified Thromboembolic and Bleeding Outcomes Following Sleeve Gastrectomy Under Uniform Extended Enoxaparin Prophylaxis.Obesity surgery · 2026Article
- Efficacy and safety of direct oral anticoagulants and low molecular weight heparin for cancer-associated venous thromboembolism in patients with extremes in bodyweight.Journal of thrombosis and thrombolysis · 2026Article
- Contemporary Challenges in Venous Thromboembolism: Evolving Populations and Implications for Management and Risk Stratification.Journal of clinical medicine · 2026Review
- Safety and Efficacy of Direct Oral Anticoagulants Compared to Warfarin in Patients with Venous Thromboembolism and Morbid Obesity.International journal of hematology-oncology and stem cell research · 2025Article
- Anti-Factor Xa Activity of Apixaban in Extremely Low Body Weight.Journal of clinical medicine · 2025Article
- Apixaban in patients with nonvalvular atrial fibrillation, heart failure and low body weight: A report from a global federated research dataset.European journal of clinical investigation · 2025Article
- Article
- Outcomes of 10 mg Rivaroxaban in Nonvalvular Atrial Fibrillation Patients With CrCl ≥ 50 mL/min: A Retrospective Cohort Study.Cardiovascular therapeutics · 2025Article
- The Influence of High Body Mass Index (BMI > 35 kg/mAmerican journal of cardiovascular drugs : drugs, devices, and other interventions · 2025Article
- Apixaban plasma concentrations in patients with obesity.European journal of clinical pharmacology · 2024Article
46 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimApixaban is an oral, direct, factor-Xa inhibitor approved for thromboprophylaxis in patients who have undergone elective hip or knee replacement surgery and for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. This open label, parallel group study investigated effects of extremes of body weight on apixaban pharmacokinetics, pharmacodynamics, safety and tolerability.
methodFifty-four healthy subjects were enrolled [18 each into low (≤50 kg), reference (65-85 kg) and high (≥120 kg) body weight groups]. Following administration of a single oral dose of 10 mg apixaban, plasma and urine samples were collected for determination of apixaban pharmacokinetics and anti-factor Xa activity. Adverse events, vital signs and laboratory assessments were monitored.
resultsCompared with the reference body weight group, low body weight had approximately 27% [90% confidence interval (CI): 8-51%] and 20% (90% CI: 11-42%) higher apixaban maximum observed plasma concentration (Cmax) and area under the concentration-time curve extrapolated to infinity (AUC(0,∞)), respectively, and high body weight had approximately 31% (90% CI: 18-41%) and 23% (90% CI: 9-35%) lower apixaban Cmax and AUC(0,∞) , respectively. Apixaban renal clearance was similar across the weight groups. Plasma anti-factor Xa activity showed a direct, linear relationship with apixaban plasma concentration, regardless of body weight group. Apixaban was well tolerated in this study.
conclusionThe modest change in apixaban exposure is unlikely to require dose adjustment for apixaban based on body weight alone. However, caution is warranted in the presence of additional factors (such as severe renal impairment) that could increase apixaban exposure.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.