Evidence map›Paper›PMID 28770534›Full record

ArticleDrug safety2018

Antidepressant-Induced Acute Liver Injury: A Case-Control Study in an Italian Inpatient Population.

Carmen Ferrajolo, Cristina Scavone, Monia Donati, Oscar Bortolami, Giovanna Stoppa, Domenico Motola, Alfredo Vannacci, Alessandro Mugelli, Roberto Leone, Annalisa Capuano and 1 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.2field-weighted citation impact, top 14% 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

8 citing papers in PubMed, 18 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

11 authors at 4 institutions in 3 countries.

Carmen FerrajoloUnit of Clinical Pharmacology, Department of Experimental Medicine, Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", via de Crecchio 7, 80138, Naples, Italy. carmen.ferrajolo@unicampania.it.ORCID 0000-0002-6228-6548
Cristina ScavoneUnit of Clinical Pharmacology, Department of Experimental Medicine, Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", via de Crecchio 7, 80138, Naples, Italy.
Monia DonatiUnit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, via Irnerio 48, 40126, Bologna, Italy.
Oscar BortolamiSchool of Health and Related Research, University of Sheffield, Regent Street, S1 4DA, Sheffield, UK.
Giovanna StoppaPharmacology Unit, Department of Diagnostics and Public Health, University of Verona, p.le L.A. Scuro 10, 37134, Verona, Italy.
Domenico MotolaUnit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, via Irnerio 48, 40126, Bologna, Italy.
Alfredo VannacciUnit of Adverse Drug Reactions Monitoring and Pharmacoepidemiology, Department of Neurosciences, Psychology, Drug Research and Child Health (NeuroFarBa), Tuscan Regional Centre of Pharmacovigilance, University of Florence, Florence, Italy.
Alessandro MugelliUnit of Adverse Drug Reactions Monitoring and Pharmacoepidemiology, Department of Neurosciences, Psychology, Drug Research and Child Health (NeuroFarBa), Tuscan Regional Centre of Pharmacovigilance, University of Florence, Florence, Italy.
Roberto LeonePharmacology Unit, Department of Diagnostics and Public Health, University of Verona, p.le L.A. Scuro 10, 37134, Verona, Italy.
Annalisa CapuanoUnit of Clinical Pharmacology, Department of Experimental Medicine, Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", via de Crecchio 7, 80138, Naples, Italy.
DILI-IT Study Group
University of Campania "Luigi Vanvitelli" · ITUniversity of Verona · ITUniversity of Florence · ITUniversity of Sheffield · GB

Funding

Italian Medicines Agency (AIFA) FARM8B2TY7
6 · The paper itself

Abstract

introductionPre-marketing clinical trials show that antidepressant-induced liver injury seems to be a rare adverse event. Because of short follow-up trial duration, the incidence of liver injury due to antidepressant use could be underestimated.

objectivesWe aimed to quantify the risk of acute liver injury associated with antidepressant use through a case-control analysis among an inpatient population.

methodsA multicenter study was carried out in nine Italian hospitals from October 2010 to January 2014, within the DILI-IT (Drug-Induced Liver Injury in Italy) study project. After exclusion of all patients with a clear competing cause of liver injury, cases were defined as adults admitted to the hospital with a diagnosis of acute liver injury, while controls had any other acute clinical condition not related to the liver. Antidepressant exposure was evaluated within 90 days prior to the date of the first sign/symptom of liver injury. Odds ratio (OR) with 95% confidence interval (95% CI) was calculated as a measure of risk estimates for liver injury.

resultsWe included 17 cases exposed to antidepressants matched to 99 controls. According to the features of liver injury, all cases showed symptomatic liver function test abnormalities at hospital admission, with the main signs/symptoms represented by fatigue, nausea, asthenia, or dark urine. Citalopram was the antidepressant mostly involved in the increase of liver enzymes, mainly alanine aminotransferase. Compared with non-use, current use of antidepressants was associated with a significantly increased risk of liver injury (adjusted OR, OR

conclusionThe use of antidepressants is not as safe in terms of liver injury as expected; instead, the risk of antidepressant-induced liver injury is likely underestimated. The lack of significance does not reflect the absence of risk, but rather suggests the need to evaluate it in a wider setting of antidepressant users.

Indexed as

InpatientsAntidepressive AgentsCase-Control StudiesChemical and Drug Induced Liver InjuryDepressive DisorderFemaleHumansIncidenceItalyMaleMiddle AgedAntidepressive Agents

Identifiers

PMID28770534
OpenAlexW2741507568

What OpenQuestion holds

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Registered trials

None linked

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.