Letters to the Editor

Comments on the Use of Agomelatine in the Treatment of Depressive Disorder According to Clinical Guidelines in Colombia

Comentario sobre la calificación de agomelatina en el tratamiento del trastorno depresivo según guías clínicas en Colombia

Sidney H. Kennedy^*

Chair, CANMAT Depression Guidelines Group, Psychiatrist-in-Chief, UHN, Professor of Psychiatry, University of Toronto, Toronto, Canada

^*Corresponding author. Email: Sidney.Kennedy@uhn.ca (S.H. Kennedy).

Dear Editor,

As a proponent of guidelines for the treatment of Major Depressive Disorder (MDD), I read with interest the "Guía de atención Integral para la detección temprana y diagnóstico del episodio depresivo y trastorno depresivo recurrente en adultos", published in the December issue of Revista Colombiana de Psiquiatría,¹ and I congratulate the authors on this contribution to improving the lives of people with MDD.

However, I must take exception to the comments regarding agomelatine that "the use of agomelatine is not recommended because there is not enough evidence at this time to support its efficacy".

I am the author of an extensive review published in 2010 on the clinical evidence from published and unpublished trials up to 2010 involving placebo controlled trials and direct head to head comparisons with a broad range of currently prescribed antidepressants². The evidence to support clinical efficacy and excellent tolerability is robust. Since then, new clinical trials have been published and have been the subject of two additional reviews. In the first one, Kasper et al³ reported the results of a meta-analysis of individual patient data from the direct head-to-head double-blind randomized studies, from 6 to 12 weeks of duration, comparing agomelatine with other antidepressants where the HAM-D₁₇ was the primary outcome measure. These authors reported a greater reduction of the HAM-D₁₇ with agomelatine than with SSRI/SNRI (0.86±0.35, 95% confidence interval, 0.18-1.53; P=.013).

The second publication⁴, meta-analysis evaluated the efficacy of agomelatine at 24 weeks, compared with selective serotonin reuptake inhibitors (SSRIs), based on the results of four randomized clinical trials⁴. At the last post-baseline assessment of the 24-week treatment period, there was a significant difference on HAM-D₁₇ final scores in patients treated with agomelatine compared to those treated with SSRIs (P=.014). Quite appropriately, the Columbian guide places strong emphasis on HAM-D remission rates. Remission rates for agomelatine were numerically but not significantly higher in patients treated with SSRIs at 24 weeks. In this report, Demyttenaere et al⁴ concluded that "from a clinical point of view, agomelatine is at least as efficacious as the investigated SSRIs".

Given the overall disappointing rates of response and remission reported in STAR*D⁵, physicians should be made aware of all options to treat their depressed patients. Agomelatine, with a unique mode of action and a strong evidence base for efficacy and effectiveness, should certainly be included as a treatment option. I consider that there is adequate evidence to support the use of agomelatine as a first line treatment for major depressive episodes.

References

1. Bohórquez Peñaranda AP, García Valencia J, Rodríguez Guarín M, Arenas Borrero AE, Castro Díaz SM, De la Hoz Bradford AM et al. Guía de atención integral para la detección temprana y diagnóstico del episodio depresivo y trastorno depresivo recurrente en adultos. Atención integral de los adultos con diagnóstico de episodio depresivo o trastorno depresivo recurrente. Parte II: Aspectos generales del tratamiento, manejo de la fase aguda, continuación y mantenimiento del paciente con diagnóstico de depresión. Rev Colomb Psiquiatr. 2012;41:740-73.         [ Links ]

2. Kennedy SH, Rizvi SJ. Agomelatine in the treatment of major depressive disorder: potential for clinical effectiveness. CNS Drugs. 2010;24:479-99.         [ Links ]

3. Kasper S, Corruble E, Hale A, Lemoine P, Montgomery SA, Quera-Salva MA. Antidepressant efficacy of agomelatine versus SSRI/SNRI: results from a pooled analysis of head-to-head studies without a placebo control. Int Clin Psychopharmacol. 2013;28:12-9.         [ Links ]

4. Demyttenaere K, Corruble E, Hale A, Quera-Salva MA, Picarel-Blanchot F, Kasper S. A pooled analysis of six month comparative efficacy and tolerability in four randomized clinical trials: agomelatine versus escitalopram, fluoxetine, and sertraline. CNS Spectr. 2013;18:163-70.         [ Links ]

5. Warden D, Rush AJ, Trivedi MH, Fava M, Wisniewski SR. The STAR*D Project results: a comprehensive review of findings. Curr Psychiatry Rep. 2007;9:449-59.         [ Links ]