Subgroup analysis of the non-interventional study VIVALDI: Agomelatine in treatment-naïve patients, in combination therapy and after treatment switch

Abstract

Objective. Agomelatine has demonstrated antidepressant efficacy in randomized, controlled trials. This non-interventional study VIVALDI evaluated agomelatine treatment under practice conditions. Methods. Psychiatrists documented the treatment of 3,317 patients over 12 weeks. According to the treatment condition three subgroups were selected: Agomelatine in treatment-naïve patients as mono-therapy (A), in pretreated patients as add-on-therapy (B), and in pretreated patients switched to agomelatine (C). Effect on depressive symptoms was evaluated via svMADRS and CGI. Daytime functioning and sleep–wake rhythm were assessed by a patient-questionnaire. Results. The svMADRS decreased from values > 30 at baseline to 12.8 (total population), 10.3 (A), 15.1 (B), and 13.5 (C). 76.1%, 55.7%, and 62.5% of patients were responders in subgroups A, B, and C, respectively, 65.8% in the total population. Remission was achieved in 66.5% (A), 44.7% (B), and 50.9% (C) of patients. After 12 weeks, subjective sleep quality and daytime functioning improved in the majority of patients. Adverse drug reactions (ADR/serious ADR) were reported for 6.0%/0% (A), 11.0%/0.2% (B), and 12.6%/0.3% (C) of patients. Overall, 25.8% of patients discontinued treatment prematurely, 5.2% due to ADR. Conclusion. Agomelatine improved depressive symptoms, daytime functioning, and sleep–wake rhythm, and demonstrated good tolerability also in pretreated patients and combination therapy under routine practice.

Key words::

• Agomelatine
• non-interventional study
• depression
• circadian rhythms
• combination therapy
• treatment switch

Acknowledgments

The authors thank GKM Gesellschaft für Therapieforschung mbH, Munich, for their substantive contribution to data management and statistical analysis, and all investigators for their contributions to the study. The study was supported by Servier Deutschland GmbH, Munich.

Statement of interest

GL has received grants, and acted as consultant, advisor, or speaker for the following companies: Astra-Zeneca, Bayer, Boehringer Ingelheim, Janssen-Cilag, Lilly, Lundbeck, Merz, Novartis, Organon,Pfizer, Servier, Steigerwald, Teva, Wyeth.

NH is an employee of Servier Deutschland GmbH.