Evidence map›Paper›PMID 41137789›Full record

ArticlePharmacoepidemiology and drug safety2025

Association Between Statins Use and Major Bleeding in Patients Using Direct Oral Anticoagulants for Atrial Fibrillation.

A de Burgos-González, L Cea-Soriano, C Huerta-Álvarez

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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

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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

2 citing papers in PubMed.

  1. Article
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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

3 authors.

A de Burgos-GonzálezDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
L Cea-SorianoDepartment of Public Health and Maternal Child Health, Faculty of Medicine, Complutense University of Madrid, Madrid, Spain.ORCID 0000-0002-7051-0730
C Huerta-ÁlvarezDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.

Funding

National Tender Proyectos de Investigación en Salud, 2017, Acción Estratégica de Salud PI17/02091Spanish Agency on Medicines and Medical Devices (AEMPS)
6 · The paper itself

Abstract

backgroundDirect oral anticoagulants (DOAC) were developed as an alternative to vitamin K antagonists in the treatment of NVAF. Statins are frequently prescribed drugs for the prevention of atherosclerotic cardiovascular disease. A potential interaction between DOACs and statins has been described, suggesting that their concomitant use may increase the risk of major bleeding (MB). PURPOSE: To estimate the risk of MB associated with concomitant use of DOACs and statins to assess potential safety issues.

methodsA case-control study nested in a cohort of new users of DOACs was performed in BIFAP. Cases were defined as MB events and matched to four controls by risk-set sampling. Treatment episodes were built to define the participants' exposure according to their use at index date as current, recent, past, or no use. Exposure was also assessed in relation to its continuity and duration. Variables were created based on the concomitant use of DOACs and statins to study the interaction, using conditional logistic regression to estimate the risk of MB.

resultsaOR (95% CI) for current use of DOAC or statin use were 1.35 (0.96-1.9) and 0.72 (0.59-0.88). aOR for their concomitant use was 1.31 (0.83-2.07) compared to nonuse of either of them. DOAC continuous use (1.27; 0.8-2.03) and long-term (1.11; 0.67-1.81) treatment was associated with smaller risks than noncontinuous (1.40; 0.85-2.32) and short-term treatment (1.43; 0.94-2.45). Analyses by individual DOACs and statins showed similar results except for edoxaban, which had low numbers.

conclusionsThere was no evidence to suggest an interaction between DOACs and statins and the risk of MB. Regular use of DOACs is important to minimize their impact on MB onset.

Indexed as

AnticoagulantsAtrial FibrillationHemorrhageHydroxymethylglutaryl-CoA Reductase InhibitorsAdministration, OralAgedAged, 80 and overCase-Control StudiesCohort StudiesDrug InteractionsFactor Xa InhibitorsFemaleHumansMaleMiddle AgedAnticoagulantsFactor Xa InhibitorsHydroxymethylglutaryl-CoA Reductase InhibitorsDOACmajor bleedingnested case control studystatins

Identifiers

PMID41137789
PMCPMC12553355

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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.