The safety of agomelatine in standard medical practice in depressed patients: A 26-week international multicentre cohort study.
agomelatine
liver acceptability
observational
safety-medical practice
skin events
Journal
Human psychopharmacology
ISSN: 1099-1077
Titre abrégé: Hum Psychopharmacol
Pays: England
ID NLM: 8702539
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
11
02
2020
revised:
12
05
2020
accepted:
08
09
2020
pubmed:
26
9
2020
medline:
17
12
2021
entrez:
25
9
2020
Statut:
ppublish
Résumé
The present observational cohort study documented the safety of agomelatine in current medical practice in out-patients suffering from major depressive disorder. The 6-month evolution of agomelatine-treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI-S) score, and functioning measured by the Sheehan Disability Scale (SDS). A total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.7%; mean age: 49.1 ± 14.8 years). Adverse events reported were in accordance with the known safety profile of agomelatine. Cutaneous events were reported in 1.7% of the patients and increased hepatic transaminases values were reported in 0.9 % of the patients. The incidence of events related to suicide/self-injury was 1.0%. Two completed suicides, not related to the study drug, were reported. CGI-S total scores and SDS sub-scores improved and numbers of days lost or underproductive decreased over the treatment period. In standard medical practice, agomelatine treatment was associated with a low incidence of side effects. No unexpected events were reported. A decrease in the severity of the depressive episode and improved functioning were observed. Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients. A prospective, observational (non-interventional), international, multicentre cohort study. ISRCTN53570733.
Identifiants
pubmed: 32976677
doi: 10.1002/hup.2759
pmc: PMC7816263
doi:
Substances chimiques
Acetamides
0
Antidepressive Agents
0
agomelatine
137R1N49AD
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-11Informations de copyright
© 2020 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons Ltd.
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