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.
Acetamides
/ adverse effects
Adolescent
Antidepressive Agents
/ adverse effects
Case-Control Studies
Chemical and Drug Induced Liver Injury
/ etiology
Depression
/ drug therapy
Depressive Disorder, Major
/ drug therapy
Europe
Female
Humans
Information Storage and Retrieval
Liver
/ drug effects
Longitudinal Studies
Male
Retrospective Studies
Selective Serotonin Reuptake Inhibitors
/ adverse effects
Journal
CNS drugs
ISSN: 1179-1934
Titre abrégé: CNS Drugs
Pays: New Zealand
ID NLM: 9431220
Informations de publication
Date de publication:
04 2019
04 2019
Historique:
pubmed:
5
3
2019
medline:
4
8
2020
entrez:
5
3
2019
Statut:
ppublish
Résumé
Agomelatine is a melatonin receptor agonist and serotonin 5-HT The 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. A 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. We 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. In 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.
Sections du résumé
BACKGROUND
Agomelatine is a melatonin receptor agonist and serotonin 5-HT
OBJECTIVE
The 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.
METHOD
A 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.
RESULTS
We 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.
CONCLUSION
In 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.
Identifiants
pubmed: 30830574
doi: 10.1007/s40263-019-00611-9
pii: 10.1007/s40263-019-00611-9
pmc: PMC6441103
doi:
Substances chimiques
Acetamides
0
Antidepressive Agents
0
Serotonin Uptake Inhibitors
0
agomelatine
137R1N49AD
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
383-395Références
BMC Gastroenterol. 2015 Oct 14;15:134
pubmed: 26467777
Pharmacoepidemiol Drug Saf. 2016 Mar;25 Suppl 1:21-8
pubmed: 26147715
J Clin Psychiatry. 2014 Dec;75(12):e1428-32
pubmed: 25551239
Pharmacoepidemiol Drug Saf. 2019 Jul;28(7):965-975
pubmed: 31172633
Am J Epidemiol. 2009 May 15;169(10):1182-90
pubmed: 19363102
Am J Manag Care. 2005 Jul;11(7):449-57
pubmed: 16044982
BMJ. 2003 Jul 5;327(7405):18-22
pubmed: 12842950
Curr Drug Saf. 2013 Jul;8(3):207-23
pubmed: 23914755
Br J Psychiatry. 2015 Sep;207(3):221-6
pubmed: 26159603
J Clin Psychopharmacol. 2011 Aug;31(4):517-22
pubmed: 21694615
Expert Opin Drug Saf. 2014 Jan;13(1):67-81
pubmed: 24073714
Scand J Public Health. 2011 Jul;39(7 Suppl):30-3
pubmed: 21775347
Drug Saf. 2013 Aug;36(8):651-61
pubmed: 23670723
Eur J Clin Pharmacol. 2014 Oct;70(10):1227-35
pubmed: 25066450
Pharmacoepidemiol Drug Saf. 2013 Feb;22(2):190-8
pubmed: 23258383
J Clin Pharmacol. 2016 Jun;56(6):769-78
pubmed: 26470856
Clin Epidemiol. 2012;4:303-13
pubmed: 23204870
J Hepatol. 2015 Aug;63(2):503-14
pubmed: 25912521
J Clin Psychopharmacol. 2014 Jun;34(3):327-30
pubmed: 24561328
J Clin Epidemiol. 1993 Nov;46(11):1323-30
pubmed: 8229110
NCHS Data Brief. 2017 Aug;(283):1-8
pubmed: 29155679
Basic Clin Pharmacol Toxicol. 2010 Feb;106(2):86-94
pubmed: 19961477
Int J Epidemiol. 2018 Apr 1;47(2):382-384f
pubmed: 29346556
Am J Psychiatry. 2014 Apr;171(4):404-15
pubmed: 24362450
Int J Epidemiol. 2017 Jun 1;46(3):798-798f
pubmed: 27789670
Pharmacotherapy. 2014;34(4):336-49
pubmed: 24865821
Drug Saf. 2017 Jun;40(6):505-515
pubmed: 28194654
Pharmacoepidemiol Drug Saf. 2015 Jul;24(7):676-83
pubmed: 25866286
Eur J Clin Pharmacol. 2017 Jan;73(1):105-113
pubmed: 27752752
BMJ Open. 2016 Oct 8;6(10):e012182
pubmed: 27855095
CNS Drugs. 2018 Jul;32(7):673-684
pubmed: 29959758
Mayo Clin Proc. 2014 Jan;89(1):95-106
pubmed: 24388027
Alcohol Clin Exp Res. 2015 Feb;39(2):371-9
pubmed: 25597432
Int J Epidemiol. 2008 Apr;37(2):382-5
pubmed: 18184671
Clin Epidemiol. 2015 Nov 17;7:449-90
pubmed: 26604824
Pharmacoepidemiol Drug Saf. 2013 Aug;22(8):861-72
pubmed: 23801638
Eur J Epidemiol. 2014 Aug;29(8):541-9
pubmed: 24965263
Clin Pharmacol Ther. 2011 Jun;89(6):806-15
pubmed: 21544079
Ann Ist Super Sanita. 1999;35(3):429-33
pubmed: 10721209
BMC Public Health. 2011 Jun 09;11:450
pubmed: 21658213
Curr Drug Saf. 2014 Mar;9(1):23-8
pubmed: 24111729
Pharmacoepidemiol Drug Saf. 2007 Jul;16(7):726-35
pubmed: 16897791
Br J Clin Pharmacol. 2015 Jun;79(6):988-99
pubmed: 25444550
Pharmacoepidemiol Drug Saf. 2008 Mar;17(3):215-23
pubmed: 18200610
Drug Saf. 2018 Jan;41(1):95-102
pubmed: 28770534
Am J Gastroenterol. 2007 Nov;102(11):2437-43
pubmed: 17662100