ArticleDrug safety2018
Non-bleeding Adverse Events with the Use of Direct Oral Anticoagulants: A Sequence Symmetry Analysis.
Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 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
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Prescribing Cascades with Recommendations to Prevent or Reverse Them: A Systematic Review.Drugs & aging · 2023Pooled it
- Prescribing cascades in community-dwelling adults: A systematic review.Pharmacology research & perspectives · 2022Pooled it
- Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews.Drug safety · 2019Pooled it
- Are the Direct Oral Anticoagulants Better Than Warfarin for the Prevention and Treatment of Stroke and Atrial Fibrillation?Handbook of experimental pharmacology · 2026Review
- Article
- Retrospective analysis of gastrointestinal bleedings with direct oral anticoagulants reported to EudraVigilance.Naunyn-Schmiedeberg's archives of pharmacology · 2023Article
- Contemporary Antiplatelet and Anticoagulant Therapies for Secondary Stroke Prevention: A Narrative Review of Current Literature and Guidelines.Current neurology and neuroscience reports · 2023Review
- Bleeding related to oral anticoagulants: Trends in US emergency department visits, 2016-2020.Thrombosis research · 2023Article
- State-of-the-art review - A review on snake venom-derived antithrombotics: Potential therapeutics for COVID-19-associated thrombosis?International journal of biological macromolecules · 2021Review
- Direct Oral Anticoagulants: From Randomized Clinical Trials to Real-World Clinical Practice.Frontiers in pharmacology · 2021Review
- Acute Renal Failure in a Patient with Rivaroxaban-Induced Hypersensitivity Syndrome: A Case Report with a Review of the Literature and of Pharmacovigilance Registries.Case reports in nephrology · 2020Article
- Association between oral anticoagulants and osteoporosis: Real-world data mining using a multi-methodological approach.International journal of medical sciences · 2020Article
- Assessment of Medication Safety Using Only Dispensing Data.Current epidemiology reports · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPostmarketing pharmacovigilance reports have raised concerns about non-bleeding adverse events associated with direct oral anticoagulants (DOACs), but only limited results are available from large claims databases.
objectiveThe aim of this study was to assess the potential association between DOAC initiation and the onset of four types of non-bleeding adverse events by sequence symmetry analysis (SSA).
methodsSSA was performed using nationwide data from the French National Healthcare databases (Régime Général, 50 million beneficiaries) to assess a cohort of 386,081 DOAC new users for the first occurrence of four types of non-bleeding outcomes: renal, hepatic, skin outcomes identified by using hospitalization discharge diagnoses, and gastrointestinal outcomes by using medication reimbursement. Asymmetry in the distribution of each investigated outcome occurring before and after initiation of DOAC therapy was used to test the association between DOAC therapy and these outcomes. SSA inherently controls for time-constant confounders, and adjusted sequence ratios were computed after correcting for temporal trends. Negative (glaucoma) and positive (bleeding, depressive disorders) control outcomes were used and analyses were replicated on a cohort of 310,195 patients initiating a vitamin K antagonist (VKA).
resultsThis study demonstrated the expected positive association between either DOAC or VKA therapy and hospitalised bleeding and initiation of antidepressant therapy, while no association was observed between either DOAC or VKA therapy and initiation of antiglaucoma medications. For DOAC therapy, signals were the associations with hepatic outcomes, including acute liver injury [for the 3-month time window, aSR
conclusionResults of this nationwide study suggest that DOACs are associated with rare but severe liver injury and more frequent gastrointestinal disorders. A low risk of kidney injury with DOAC therapy can also not be excluded.
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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.