Evidence map›Paper›PMID 36986554›Full record

ArticlePharmaceuticals (Basel, Switzerland)2023

A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database.

Claudiu Morgovan, Carmen Maximiliana Dobrea, Adriana Aurelia Chis, Anca Maria Juncan, Anca Maria Arseniu, Luca Liviu Rus, Felicia Gabriela Gligor, Simona Alexandrina Ardelean, Laurentiu Stoicescu, Steliana Ghibu and 1 more

Abstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. An assessment of anti-VEGF drugs safety based on real-world data: from popularity to spontaneous reporting in eudravigilance database.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  7. Article
  8. Article
  9. Assessment of the biosafety profile ofWorld journal of cardiology · 2025
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Claudiu MorgovanPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0003-2730-8729
Carmen Maximiliana DobreaPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-9913-1750
Adriana Aurelia ChisPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-3128-2763
Anca Maria JuncanPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-5064-0239
Anca Maria ArseniuPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Luca Liviu RusPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0002-3622-2815
Felicia Gabriela GligorPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0003-3167-9864
Simona Alexandrina ArdeleanDepartment of Pharmaceutical Sciences, Faculty of Pharmacy, "Vasile Goldis" Western University of Arad, 310025 Arad, Romania.
Laurentiu StoicescuDepartment of Cardiology, Vth Medical Clinic, Faculty of Medicine, "Iuliu Haţieganu" University of Medicine and Pharmacy, 400139 Cluj-Napoca, Romania.
Steliana GhibuDepartment of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, "Iuliu Haţieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania.ORCID 0000-0003-2247-4613
Adina FrumPreclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.ORCID 0000-0003-4874-0430

Funding

Lucian Blaga University of Sibiu LBUS-IRG-2022-08/No. 2922, July 18th, 2022
6 · The paper itself

Abstract

Direct oral anticoagulant drugs (DOACs) interfere with the coagulation process, thus improving patient care for those who require anticoagulant treatment. This study presents a descriptive analysis of adverse reactions (ADRs) attributed to DOAC dosage errors (overdose, underdose, and improper dose). The analysis was performed based on the Individual Case Safety Reports from the EudraVigilance (EV) database. Results show that data reported for rivaroxaban, apixaban, edoxaban, and dabigatran are mostly regarding underdosing (51.56%) compared to overdosing (18.54%). The most dosage error reports were identified for rivaroxaban (54.02%), followed by apixaban (33.61%). Dabigatran and edoxaban had similar percentages (6.26% and 6.11%, respectively) regarding dosage error reports. Since coagulation issues can become life-threatening events, and factors such as advanced age and renal failure can influence the pharmacokinetics of drugs, the correct usage of DOACs is of utmost importance for the management and prevention of venous thromboembolism. Thus, the collaboration and the complementarity of knowledge of physicians and pharmacists may offer a reliable solution for DOAC dose management and improve patient care.

Indexed as

DOACsdosage errorsEudraVigilanceoverdosesafety profileunderdose

Identifiers

PMID36986554
PMCPMC10056464

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Registered trials

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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.