ArticleCNS drugs2019
Risk of Acute Liver Injury in Agomelatine and Other Antidepressant Users in Four European Countries: A Cohort and Nested Case-Control Study Using Automated Health Data Sources.
Article in CNS drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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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.
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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.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Efficacy of Agomelatine 25-50 mg for the Treatment of Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder: A Meta-Analysis of Three Placebo-Controlled Studies.Advances in therapy · 2021Pooled it
- Melatonergic Modulation of SIRT1-Nrf2 Signaling Protects Against Doxorubicin-Induced Hepatic Injury in Rats.Biomedicines · 2026Article
- Agomelatine and the potential inverse risk of metabolic disorders: a nationwide cohort study with an active comparator design in Taiwan.Diabetology & metabolic syndrome · 2026Article
- Pharmacological Monotherapy for Depressive Disorders: Current and Future-A Narrative Review.Medicina (Kaunas, Lithuania) · 2025Review
- Efficient analysis of drug interactions in liver injury: a retrospective study leveraging natural language processing and machine learning.BMC medical research methodology · 2024Article
- Hepatotoxicity Score: A New Method to Adjust for Use of Potentially Hepatotoxic Medications by Chronic Liver Disease Status.Pharmacoepidemiology and drug safety · 2024Article
- Utilization and safety of trastuzumab emtansine (T-DM1): a nationwide population-based study using the French National Health Data System.ESMO real world data and digital oncology · 2024Article
- Validation of diagnoses of liver disorders in users of systemic azole antifungal medication in Sweden.BMC gastroenterology · 2024Article
- Sertraline induced acute hepatocellular liver injury in patient with major depressive disorder: a case report.Frontiers in psychiatry · 2024Article
- Chronic Insomnia Disorder across Europe: Expert Opinion on Challenges and Opportunities to Improve Care.Healthcare (Basel, Switzerland) · 2023Review
- Agomelatine for the treatment of generalized anxiety disorder: focus on its distinctive mechanism of action.Therapeutic advances in psychopharmacology · 2022Review
- Acute Hepatitis Due to Agomelatine Use in Elderly Women with Depression: Case Series.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2021Article
- CYP1A2 polymorphism may contribute to agomelatine-induced acute liver injury: Case report and review of the literature.Medicine · 2021Review
- The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study.Human psychopharmacology · 2021Observational
- Validity of ICD-9 and ICD-10 codes used to identify acute liver injury: A study in three European data sources.Pharmacoepidemiology and drug safety · 2019Article
Corrections and comments
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Authors and funding
24 authors at 9 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAgomelatine is a melatonin receptor agonist and serotonin 5-HT
objectiveThe goal was to estimate the risk of ALI associated with agomelatine and other antidepressants (fluoxetine, paroxetine, sertraline, escitalopram, mirtazapine, venlafaxine, duloxetine, and amitriptyline) when compared with citalopram in routine clinical practice.
methodA nested case-control study was conducted using data sources in Denmark, Germany, Spain, and Sweden (study period 2009-2014). Three ALI endpoints were defined using International Classification of Diseases (ICD) codes: primary (specific codes) and secondary (all codes) endpoints used only hospital discharge codes; the tertiary endpoint included both inpatient and outpatient settings (all codes). Validation of endpoints was implemented. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for current use were estimated for each data source and combined.
resultsWe evaluated 3,238,495 new antidepressant and 74,440 agomelatine users. For the primary endpoint, the OR for agomelatine versus citalopram was 0.48 (CI 0.13-1.71). Results were also < 1 when no exclusion criteria were applied (OR 0.37; CI 0.19-0.74), when all exclusion criteria except alcohol and drug abuse were applied (OR 0.47; CI 0.20-1.07), and for the secondary (OR 0.40; CI 0.05-3.11) and tertiary (OR 0.79; CI 0.50-1.25) endpoints. Regarding other antidepressants versus citalopram, most OR point estimates were also below one, although with varying widths of the 95% CIs. The result of the tertiary endpoint and the sensitivity analyses of the primary endpoint were the most precise.
conclusionIn this study, using citalopram as a comparator, agomelatine was not associated with an increased risk of ALI hospitalisation. The results for agomelatine should be interpreted in the context of the European risk minimisation measures in place. Those measures may have induced selective prescribing and could explain the lower risk of ALI for agomelatine when compared with citalopram. Most other antidepressants evaluated had ORs suggesting a lower risk than citalopram, but additional studies are required to confirm or refute these results.
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Registered trials
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