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DOI: 10.1055/s-0037-1616456
Mono-, Kombinations- und Augmentationstherapie depressiver Patienten mit Agomelatin
Ergebnisse einer Subgruppenanalyse der Studie VIVREMono-, combination and augmentation therapy of depressive patients with agomelatineResults of a subgroup analysis of the study VIVREPublication History
eingegangen am:
08 February 2016
angenommen am:
21 September 2016
Publication Date:
10 January 2018 (online)
Zusammenfassung
Gegenstand und Ziel: Die Subgruppenanalyse der nicht interventionellen Studie VIVRE (Valdoxan® ImproVes depRession with anxiEty symptoms) evaluierte die Verbesserung von Angstsymptomen der Depression und sozialer Funktionsfähigkeit unter Agomelatin, abhängig von der antidepressiven bzw. psychotropen Komedikation. Methoden: Patienten von 4 Subgruppen (A–D) erhielten über 12 Wochen Agomelatin in Monotherapie (A, n = 965), Kombinationstherapie (B, n = 187), Augmentationstherapie (C, n = 549) oder in Kombinations- plus Augmentationstherapie (D, n = 190). Der klinische Verlauf wurde mit Clinical-Global-Impression (CGI), Patient-Global-Impressions (PGI), COVI- und Sheehan-Disability-Skala (SDS) dokumentiert. Ergebnisse: Die depressive Symptomatik verbesserte sich bei mehr als drei Viertel der Patienten aller Subgruppen mit Response-/Remissionsraten (CGI-I/S) von 83,0%/44,1% (A), 75,3%/23,2% (B), 86,1%/42,2% (C) und 70,3%/26% (D). Die Angstsymptome der Depression (COVI) verbesserten sich bei 92,7% (A), 91,3% (B), 94,8% (C) und 89,8% (D) und die soziale Funktionsfähigkeit (SDS) bei 94,3% (A), 93,2% (B), 95,8% (C) und 93,1% (D) der Patienten. Schlussfolgerung: Verbesserung von depressiven Symptomen, Angstsymptomen bei Depression und sozialer Funktionsfähigkeit konnten unter Agomelatin sowohl als Mono-, Kombinations- bzw. Augmentationstherapie bei guter Verträglichkeit im Praxisalltag beobachtet werden.
Summary
Objective: The subgroup analysis of the non-interventional study VIVRE investigated the improvements of agomelatine on depressive symptoms, depression-related anxiety symptoms and social functioning depending on antidepressant or psychotropic comedication. Methods: Patients were divided into 4 subgroups (A-D) with agomelatine for 12 weeks either in monotherapy (A, n = 965), combination- (B, n = 187), augmentation- (C, n = 549), or both combination- and augmentation- therapy (D, n = 190). Clinical effects were evaluated by use of Clinical Global Impressions- (CGI), Patient Global Impressions- (PGI), COVI- and Sheehan-Disability-Scale (SDS). Results: Depressive symptoms improved in more than three quarters of patients of all subgroups. The percentage of responder/remitters (CGI-I/S) was 83,0%/44.1% (A), 75.3%/23.2% (B), 86.1%/42.2% (C) and 70.3%/26% (D). Anxiety symptoms of depression (COVI) improved in 92.7% (A), 91.3% (B), 94.8% (C) and 89.8% (D) and social functioning (SDS) in 94.3% (A), 93.2% (B), 95.8% (C) und 93.1% (D) of patients. Conclusion: Improvements on depressive symptoms, depression-related anxiety symptoms and social functioning were observed under agomelatine in monotherapy, combination or augmentation together with a good safety profile in daily practice.
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