Trial reportBritish journal of clinical pharmacology2007
Rivaroxaban (BAY 59-7939)--an oral, direct Factor Xa inhibitor--has no clinically relevant interaction with naproxen.
Trial report in British journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis 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
46 citing papers in PubMed, 1 synthesis or guideline pooled it, 158 citations in OpenAlex.
- Investigating Intestinal Transporter Involvement in Rivaroxaban Disposition through Examination of Changes in Absorption.Pharmaceutical research · 2021Pooled it
- Evaluation of the effect of naproxen on the pharmacokinetics and pharmacodynamics of apixaban.British journal of clinical pharmacology · 2014Trial
- Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.Clinical pharmacokinetics · 2014Trial
- Population pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery.Clinical pharmacokinetics · 2008Trial
- Pharmacokinetic Variability of Direct Oral Anticoagulants and Calcium Channel Blockers: A Comparative Analysis of Exposure Data from Clinical Studies.Pharmaceutics · 2026Article
- Optimization of wet granulation process for manufacturing Rivaroxban generic immediate-release tablets using PBPK modeling and simulations.In silico pharmacology · 2024Article
- 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2021Article
- Drug-Drug Interactions Leading to Adverse Drug Reactions with Rivaroxaban: A Systematic Review of the Literature and Analysis of VigiBase.Journal of personalized medicine · 2021Review
- An engineered factor Va prevents bleeding induced by direct-acting oral anticoagulants by different mechanisms.Blood advances · 2020Article
- Drug-Drug Interactions with Direct Oral Anticoagulants.Clinical pharmacokinetics · 2020Review
- Clinical Management of Pharmacokinetic Drug Interactions with Direct Oral Anticoagulants (DOACs).Drugs · 2019Review
- The Significance of Drug-Drug and Drug-Food Interactions of Oral Anticoagulation.Arrhythmia & electrophysiology review · 2018Article
- 2017 consensus of the Asia Pacific Heart Rhythm Society on stroke prevention in atrial fibrillation.Journal of arrhythmia · 2017Article
- Enoxaparin and rivaroxaban have different effects on human mesenchymal stromal cells in the early stages of bone healing.Bone & joint research · 2016Article
- Effects of thromboprophylaxis on mesenchymal stromal cells during osteogenic differentiation: an in-vitro study comparing enoxaparin with rivaroxaban.BMC musculoskeletal disorders · 2016Article
- Managing patients taking novel oral anticoagulants (NOAs) in dentistry: a discussion paper on clinical implications.BMC oral health · 2016Article
- Risk of Gastrointestinal Bleeding with Rivaroxaban: A Comparative Study with Warfarin.Gastroenterology research and practice · 2016Article
- Article
- Analgesic use before and after oral anticoagulant initiation--a population-based study in Finland.European journal of clinical pharmacology · 2015Article
- Ophthalmic regional blocks: management, challenges, and solutions.Local and regional anesthesia · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsRivaroxaban (BAY 59-7939) is in advanced clinical development for the prevention and treatment of thromboembolic disorders. Frequent co-medications in the patient populations likely to receive rivaroxaban include NSAIDs. This randomized, two-way crossover study, with a naproxen run-in period, was performed to determine whether naproxen influences the tolerability, pharmacodynamics and pharmacokinetics of rivaroxaban.
methodsEleven healthy, young males received naproxen 500 mg on two consecutive days, a single dose of rivaroxaban 15 mg, or both.
resultsTreatments were well tolerated: adverse events (eight in total), reported by three subjects, were mild and not drug related. Rivaroxaban inhibited Factor Xa activity by 35% and prolonged prothrombin time [by 1.4 times baseline (tb)], activated partial thromboplastin time (1.3 tb) and the HepTest (1.9 tb). Naproxen had no influence on these measures and the combination of rivaroxaban and naproxen did not affect platelet aggregation. Rivaroxaban and naproxen given together significantly increased bleeding time compared with rivaroxaban alone (P = 0.017). However, this difference was small compared with the effect of naproxen given alone, except in one subject. Least squares-means ratios for the AUC and C(max) of rivaroxaban after administration alone and with naproxen were 1.125 [90% confidence interval (CI) 0.995, 1.271] and 1.095 (90% CI 0.905, 1.325), respectively.
conclusionsThere appeared to be no clinically relevant interaction between rivaroxaban and naproxen in healthy subjects, although some individuals may be more sensitive to the combination. Large-scale Phase III clinical studies will be required to confirm whether there is an increased risk of bleeding during treatment with rivaroxaban and concomitant NSAIDs.
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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.