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A pooled analysis of six month comparative efficacy and tolerability in four randomized clinical trials: agomelatine versus escitalopram, fluoxetine, and sertraline

Published online by Cambridge University Press:  11 March 2013

Koen Demyttenaere*
Affiliation:
Department of Psychiatry, University Psychiatric Center KU Leuven, Leuven, Belgium
Emanuelle Corruble
Affiliation:
Department of Psychiatry, INSERM U 669, Bicêtre University Hospital, Le Kremlin Bicêtre, France
Anthony Hale
Affiliation:
Department of Psychiatry, Trust Headquarters, St Martin's Hospital, Canterbury, Kent, UK
Maria-Antonia Quera-Salva
Affiliation:
Sleep Unit, Raymond Poincaré Hospital, Garches, APHP, France
Françoise Picarel-Blanchot
Affiliation:
IRIS, Suresnes, France
Siegfried Kasper
Affiliation:
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria
*
*Address for correspondence: Koen Demyttenaere, University Psychiatric Centre University of Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium. (Email koen.demyttenaere@med.kuleuven.be)

Abstract

Objective

A pooled-analysis on the long-term outcome in four head-to-head studies: agomelatine versus fluoxetine, sertraline, and (twice) escitalopram.

Method

A meta-analytic approach was used. Hamilton Depression Rating Scale (HAM-D) scores, response and remission rates, Clinical Global Impression of Improvement (CGI-I) scores, response and remission rates, and completion rates/discontinuation rates due to adverse events were analyzed.

Results

At the last post-baseline assessment on the 24-week treatment period, the final HAM-D-17 score was significantly lower in patients treated with agomelatine than in patients treated with selective serotonin reuptake inhibitors (SSRIs), as well in the total group of patients with severe depression (P = 0.014 and 0.040, respectively). HAM-D response rates at the end of 24 weeks were significantly higher in patients treated with agomelatine than in patients treated with SSRIs, as well in the total group of patients with severe depression (P = 0.031 and 0.048, respectively). HAM-D remission rates at the end of 24 weeks were numerically but not significantly higher in patients treated with agomelatine than in patients treated with SSRIs. Final CGI-I scores were significantly lower for agomelatine. CGI-I response as well as remission rates were numerically higher in patients treated with agomelatine, without statistical significance. The percentage of patients with at least one emergent adverse event leading to treatment discontinuation was 9.4% in patients treated with SSRIs and 6.6% in patients treated with agomelatine (P = 0.065).

Conclusion

The present pooled analysis shows that, from a clinical point of view, agomelatine is at least as efficacious as the investigated SSRIs with a trend to fewer discontinuations due to adverse events.

Type
Original Research
Copyright
Copyright © Cambridge University Press 2013 

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