Trial reportBritish journal of clinical pharmacology2013
Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, 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. It is linked to trial NCT03864406 (Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants), which is not on this map. Cited by 120 papers, 10 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.
Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Healthy Volunteers
Who cites it
120 citing papers in PubMed, 10 syntheses or guidelines pooled it, 280 citations in OpenAlex.
- The 2023 WSES guidelines on the management of trauma in elderly and frail patients.World journal of emergency surgery : WJES · 2024Guideline
- Pooled it
- Network meta-analysis of anticoagulation strategies for venous thromboembolism in patients with cancer.Journal of thrombosis and thrombolysis · 2021Pooled it
- Intestinal Efflux Transporters P-gp and BCRP Are Not Clinically Relevant in Apixaban Disposition.Pharmaceutical research · 2020Pooled it
- Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world.Blood advances · 2019Pooled it
- Model-based meta-analysis to evaluate optimal doses of direct oral factor Xa inhibitors in atrial fibrillation patients.Blood advances · 2018Pooled it
- Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review.Chest · 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
- Pooled it
- Evaluating the efficacy and safety of apixaban, a new oral anticoagulant, using Bayesian meta-analysis.International journal of hematology · 2013Pooled it
- Frailty as a Marker for the Plasma Concentrations of Direct Oral Anticoagulants in Older Patients: Results of an Exploratory Study.Drugs & aging · 2023Trial
- Population Pharmacokinetics, Pharmacodynamics, and Exploratory Exposure-Response Analyses of Apixaban in Subjects Treated for Venous Thromboembolism.CPT: pharmacometrics & systems pharmacology · 2017Trial
- Standardized use of novel oral anticoagulants plasma level thresholds in a new thrombolysis decision making protocol.Journal of thrombosis and thrombolysis · 2016Trial
- Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial.Journal of the American Heart Association · 2015Trial
- Effect of ketoconazole and diltiazem on the pharmacokinetics of apixaban, an oral direct factor Xa inhibitor.British journal of clinical pharmacology · 2015Trial
- Evaluation of the effect of naproxen on the pharmacokinetics and pharmacodynamics of apixaban.British journal of clinical pharmacology · 2014Trial
- Effect of extremes of body weight on the pharmacokinetics, pharmacodynamics, safety and tolerability of apixaban in healthy subjects.British journal of clinical pharmacology · 2013Trial
- Fat-free mass index and apixaban exposure in frail hospitalized older adults: An exploratory study.The Journal of frailty & aging · 2026Article
- Pharmacokinetic Variability of Direct Oral Anticoagulants and Calcium Channel Blockers: A Comparative Analysis of Exposure Data from Clinical Studies.Pharmaceutics · 2026Article
- Excessive Apixaban Concentrations in a Bleeding Patient Treated With Pharmacological Reversal and Extracorporal Removal-A Case Report.Pharmacology research & perspectives · 2026Article
60 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
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimApixaban is an oral factor Xa inhibitor approved for stroke prevention in atrial fibrillation and thromboprophylaxis in patients who have undergone elective hip or knee replacement surgery and under development for treatment of venous thromboembolism. This study examined the safety, pharmacokinetics and pharmacodynamics of multiple dose apixaban.
methodThis double-blind, randomized, placebo-controlled, parallel group, multiple dose escalation study was conducted in six sequential dose panels - apixaban 2.5, 5, 10 and 25 mg twice daily and 10 and 25 mg once daily- with eight healthy subjects per panel. Within each panel, subjects were randomized (3:1) to oral apixaban or placebo for 7 days. Subjects underwent safety assessments and were monitored for adverse events (AEs). Blood samples were taken to measure apixaban plasma concentration, international normalized ratio (INR), activated partial thromboplastin time (aPTT) and modified prothrombin time (mPT).
resultsForty-eight subjects were randomized and treated (apixaban, n = 36; placebo, n = 12); one subject receiving 2.5 mg twice daily discontinued due to AEs (headache and nausea). No dose limiting AEs were observed. Apixaban maximum plasma concentration was achieved ~3 h post-dose. Exposure increased approximately in proportion to dose. Apixaban steady-state concentrations were reached by day 3, with an accumulation index of 1.3-1.9. Peak : trough ratios were lower for twice daily vs. once daily regimens. Clotting times showed dose-related increases tracking the plasma concentration-time profile.
conclusionMultiple oral doses of apixaban were safe and well tolerated over a 10-fold dose range, with pharmacokinetics with low variability and concentration-related increases in clotting time measures.
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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.