Nervenheilkunde 2015; 34(10): 809-817
DOI: 10.1055/s-0038-1627629
Übersichtsartikel
Schattauer GmbH

Effekte von Agomelatin bei depressiven Patienten im Praxisalltag

Ergebnisse der nicht interventionellen Studie VIVREEffects of agomelatine in depressive patients in daily medical practiceResults of the non-interventional study VIVRE
H.-P. Volz
1   Krankenhaus für Psychiatrie, Psychotherapie und Psychosomatische Medizin, Schloss Werneck, Werneck
,
M.-L. Escafit-Schülke
2   SERVIER Deutschland GmbH, Medical Affairs, München
› Author Affiliations
Further Information

Publication History

eingegangen am: 09 March 2015

Akzeptiert nach Revision: 28 May 2015

Publication Date:
22 January 2018 (online)

Zusammenfassung

Gegenstand und Ziel: Die nicht interventionelle Studie VIVRE (Valdoxan® ImproVes depRession with anxiEty symptoms) untersuchte, inwieweit das Antidepressivum Agomelatin (Valdoxan®) unter Praxisbedingungen auch soziale Funktionsfähigkeit und Angstsymptome depressiver Patienten beeinflusst. Methoden: 1 891 depressive Patienten wurden mit Agomelatin von 616 Ärzten drei Monate behandelt. Clinical-Global-Impressions (CGI) Skala, Patient-Global-Impressions (PGI) Skala, COVIAngst-Skala und Sheehan-Disability-Scale (SDS) wurden eingesetzt. Ergebnisse: Laut CGI und PGI lag die Responderrate jeweils bei 82,1% bzw. 73,1%, die Remissionrate jeweils bei 39,9% bzw. 47,6%. Angstsymptome der Depression verbesserten sich in allen COVIItems bei über 80% der Patienten. Die soziale Funktionsfähigkeit verbesserte sich in den SDSBereichen Arbeit/Schule, soziale Kontakte und Familienleben/Häusliche Verpflichtungen bei über 90% der Patienten. Die Verträglichkeit von Agomelatin wurde bei 98,2% der Patienten als “sehr gut/gut” bewertet. UAWs traten bei 2,6% der Patienten auf. Schlussfolgerung: Agomelatin zeigte im Praxisalltag eine umfassende Wirkung auf depressive Symptome, Angstsymptome der Depression und soziale Funktionsfähigkeit bei guter Verträglichkeit.

Summary

Objective: The non-interventional study VIVRE investigated under naturalistic conditions the antidepressant effects of agomelatine (Valdoxan®), as well as its effects on psychosocial functioning and depression-related anxiety symptoms. Methods: 1 891 depressive patients were treated with agomelatine by 616 physicians for three months. The Clinical Global Impressions (CGI) Scale, the Patient Global Impressions (PGI) Scale, the COVI Anxiety Scale and the Sheehan Disability Scale (SDS) were implemented. Results: According to CGI and PGI, the responder rates were 82.1% and 73.1%, respectively and the remitter rates were 39.9% and 47.6%, respectively. Anxiety symptoms of depression improved for all COVI items in more than 80% of patients. Social functioning improved according to SDS in the domains work/school, social life and family life/home responsibilities in more than 90% of patients. Tolerability of agomelatine was rated as “very good/good” in 98.2% of the patients. ADRs were reported in 2.6% of patients. Conclusion: Agomelatine shows a broad effect on depressive symptoms, on depression-related anxiety symptoms and social functioning together with a good safety profile in daily practice.

 
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