Evidence map›Paper›PMID 40192996›Full record

ArticleAging clinical and experimental research2025

Safety of direct oral anticoagulants reversal agents in older patients: an analysis of individual case safety reports of adverse drug reaction from VigiBase

Giada Crescioli, Niccolò Lombardi, Elena Arzenton, Nicoletta Luxi, Stefano Fumagalli, Roberto Bonaiuti, Costanza Cacini, Guido Mannaioni, Gianluca Trifirò, Ugo Moretti and 1 more

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In one paragraph

Article in Aging clinical and experimental research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Giada CrescioliDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Viale G. Pieraccini, 6, 50139, Florence, Italy. giada.crescioli@unifi.it.ORCID http://orcid.org/0000-0002-1071-6120
Niccolò LombardiDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Viale G. Pieraccini, 6, 50139, Florence, Italy.ORCID http://orcid.org/0000-0002-9666-0438
Elena ArzentonSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID http://orcid.org/0000-0002-9778-1522
Nicoletta LuxiSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID http://orcid.org/0009-0009-2615-0756
Stefano FumagalliDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.ORCID http://orcid.org/0000-0002-6950-3875
Roberto BonaiutiDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Viale G. Pieraccini, 6, 50139, Florence, Italy.ORCID http://orcid.org/0000-0001-9644-499X
Costanza CaciniDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Viale G. Pieraccini, 6, 50139, Florence, Italy.ORCID http://orcid.org/0009-0008-3231-5273
Guido MannaioniDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Viale G. Pieraccini, 6, 50139, Florence, Italy.ORCID http://orcid.org/0000-0002-8273-7377
Gianluca TrifiròSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID http://orcid.org/0000-0003-1147-7296
Ugo MorettiSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID http://orcid.org/0000-0001-5108-5807
Alfredo VannacciDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Viale G. Pieraccini, 6, 50139, Florence, Italy.ORCID http://orcid.org/0000-0001-5259-2026

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReal-world data on adverse drug reactions (ADRs) associated with idarucizumab and andexanet alfa are limited.

aimThis study aimed to assess the frequency, the characteristics and clinical and demographic factors associated with ADRs related to their use.

methodsThis is a retrospective analysis of ADR reports collected in Vigibase

resultsA total of 1095 Individual Case Safety Reports (ICSRs) reporting idarucizumab (72%) or andexanet alfa (28%) as suspected/interacting agents were collected. Most of the subjects were males (44.5%), with a median age of 78 years, and exposed to only one suspected/interacting medication (73.6%). ADRs were defined as serious in 88.6% of cases, with a total of 614 (56.1%) fatal cases. Compared to patients without concomitant medications, probability of serious ADRs and death were both higher in those receiving ≥ 5 concomitant medications in the idarucizumab subgroup (ROR 4.04 and 1.66, respectively) and in those receiving 1-4 concomitant medications in the andexanet alfa subgroup (ROR 5.66 and 4.80, respectively). Moreover, the probability of thromboembolic events was significantly lower for subjects aged > 75 years (ROR for 75-84 years 0.55; ROR for ≥ 85 years 0.50). DISCUSSION: In real-world, ADRs associated with idarucizumab and andexanet alfa use are generally serious, resulting in death in a high percentage of subjects.

conclusionClinicians should pay particular attention when managing individuals needing these drugs, especially if vulnerable and requiring polytherapy.

Indexed as

Antibodies, Monoclonal, HumanizedAnticoagulantsDrug-Related Side Effects and Adverse ReactionsFactor XaFactor Xa InhibitorsAdministration, OralAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overFemaleHumansMaleMiddle AgedRecombinant ProteinsRetrospective StudiesThromboembolismAntibodies, Monoclonal, HumanizedAnticoagulantsFactor XaFactor Xa InhibitorsidarucizumabPRT064445Recombinant ProteinsAdverse drug reactionAndexanet AlfaIdarucizumabObservational studyPharmacovigilance.

Identifiers

PMID40192996
PMCPMC11976745

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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.