Evidence map›Paper›PMID 22527341›Full record

ArticleEuropean journal of clinical pharmacology2012

Bleeding adverse drug reactions (ADRs) in patients exposed to antiplatelet plus serotonin reuptake inhibitor drugs: analysis of the French Spontaneous Reporting Database for a controversial ADR.

Franck Maschino, Caroline Hurault-Delarue, Leila Chebbane, Vincent Fabry, Jean Louis Montastruc, Haleh Bagheri, French Association of Regional Pharmacovigilance Centers

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Article in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 30% of its field
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

6 citing papers in PubMed, 14 citations in OpenAlex.

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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

7 authors at 2 institutions in 1 country.

Franck MaschinoService de Pharmacologie Clinique, Equipe de Pharmacoépidémiologie, INSERM U 1027, Faculté de Médecine, Université de Toulouse, 37 allées Jules Guesde, 31000, Toulouse, France.
Caroline Hurault-Delarue
Leila Chebbane
Vincent Fabry
Jean Louis Montastruc
Haleh Bagheri
French Association of Regional Pharmacovigilance Centers
Inserm · FRUniversité de Toulouse · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim of the present study was to investigate bleeding adverse drug reactions (ADRs) in patients exposed to serotonin reuptake inhibitors (SRI) plus antiplatelet agents using the French Pharmacovigilance Database (FPVDB) regarding the controversial data in the literature.

methodsThe case/non-case method was used to measure the association between bleedings and exposure to SRIs plus antiplatelet agents versus antiplatelet drugs alone.

resultsOver 3 years, a total of 1,977 spontaneous reports of ADRs were collected with antiplatelet drugs, and antiplatelet agents plus SRIs in patients aged over 50 years, of which 1,331 (67.3 %) concerned bleeding. Multivariate logistic regression analysis failed to show any significant association [adjusted ROR = 0.8 (0.5-1.2)].

conclusionThe data did not demonstrate any significant association between bleeding ADRs and exposure to SRI + antiplatelet agents versus antiplatelets alone. Considering other conflicting results, this risk should be kept in mind by physicians when treating patients with several risk factors.

Indexed as

Adverse Drug Reaction Reporting SystemsAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalCase-Control StudiesCerebral HemorrhageDrug InteractionsFemaleFranceGastrointestinal HemorrhageHemorrhageHumansLogistic ModelsMaleMiddle AgedMultivariate AnalysisAnti-Inflammatory Agents, Non-SteroidalPlatelet Aggregation InhibitorsSelective Serotonin Reuptake Inhibitors

Identifiers

PMID22527341
OpenAlexW2066626688

What OpenQuestion holds

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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.