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The safety of agomelatine in standard medical practice in depressed patients : a 26‐week international multicentre cohort study

2020Artigo científico Acesso aberto
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dc.contributor.authorGorwood, Philip
dc.contributor.authorBenichou, Jacques
dc.contributor.authorMoore, Nicholas
dc.contributor.authorÁlvarez Martínez, Enric
dc.contributor.authorMertens, Joost
dc.contributor.authorAguglia, Eugenio
dc.contributor.authorFigueira, Maria Luísa
dc.contributor.authorFalkai, Peter
dc.contributor.authorOlivier, Valérie
dc.contributor.authorWattez, Marine
dc.contributor.authorPicarel‐Blanchot, Françoise
dc.contributor.authorde Bodinat, Christian
dc.date.accessioned2021-06-01T13:56:05Z
dc.date.available2021-06-01T13:56:05Z
dc.date.issued2020
dc.description© 2020 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.pt_PT
dc.description.abstractObjective: The present observational cohort study documented the safety of agomelatine in current medical practice in out-patients suffering from major depressive disorder. Method: 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). Results: 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. Conclusions: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationHum Psychopharmacol. 2021 Jan;36(1):1-11pt_PT
dc.identifier.doi10.1002/hup.2759pt_PT
dc.identifier.eissn1099-1077
dc.identifier.issn0885-6222
dc.identifier.urihttp://hdl.handle.net/10451/48294
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherJohn Wiley & Sons, Inc.pt_PT
dc.relation.publisherversionhttps://onlinelibrary.wiley.com/journal/10991077pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectAgomelatinept_PT
dc.subjectLiver acceptabilitypt_PT
dc.subjectObservationalpt_PT
dc.subjectSafety-medical practicept_PT
dc.subjectSkin eventspt_PT
dc.titleThe safety of agomelatine in standard medical practice in depressed patients : a 26‐week international multicentre cohort studypt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage11pt_PT
oaire.citation.issue1pt_PT
oaire.citation.startPage1pt_PT
oaire.citation.titleHuman Psychopharmacology: Clinical and Experimentalpt_PT
oaire.citation.volume36pt_PT
person.familyNameFigueira
person.givenNameMaria Luisa
person.identifier.ciencia-id4018-A916-81EC
person.identifier.orcid0000-0002-7921-5375
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationdd3c81c3-e160-4582-ba61-0c7d9548cf43
relation.isAuthorOfPublication.latestForDiscoverydd3c81c3-e160-4582-ba61-0c7d9548cf43

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