The safety of agomelatine in standard medical practice in depressed patients : A 26-week international multicentre cohort study
Gorwood, Philip (Université de Paris & INSERM U1266)
Benichou, Jacques (Unité de Biostatistiques. Centre Hospitalier Universitaire de Rouen)
Moore, Nicholas (Bordeaux PharmacoEpi CIC Bordeaux CIC1401 INSERM U1219 Hôpital Pellegrin)
Álvarez Martínez, Enric (Institut d'Investigació Biomèdica Sant Pau)
Mertens, Joost (De Velse GGZ)
Aguglia, Eugenio (AOU Policlinico Vittorio-Emanuele. Clinica Psichiatrica)
Figueira, Maria-Luisa (University of Lisbon)
Falkai, Peter (University of Munich)
Olivier, Valérie (Institut de Recherches Internationales Servier (IRIS))
Wattez, Marine (Institut de Recherches Internationales Servier (IRIS))
Picarel-Blanchot, Françoise (Institut de Recherches Internationales Servier (IRIS))
de Bodinat, Christian (Institut de Recherches Internationales Servier (IRIS))
Universitat Autònoma de Barcelona

Date:	2020
Abstract:	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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Agomelatine ; Liver acceptability ; Observational ; Safety-medical practice ; Skin events
Published in:	Human Psychopharmacology, Vol. 36 (september 2020) , ISSN 1099-1077

DOI: 10.1002/hup.2759
PMID: 32976677

11 p, 314.7 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles