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Does agomelatine have a place in the treatment of depression?

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2157 (Published 20 March 2014) Cite this as: BMJ 2014;348:g2157

Rapid Response:

Re: Does agomelatine have a place in the treatment of depression?

A4: Avoid Agomelatine As Americans

Taylor and colleagues concluded that agomelatine is an effective antidepressant with similar efficacy to standard antidepressants.(1) As a raw Frenchman, I guess it could be an understatement for Agomelatine offers no benefit over other antidepressants.

Ambresin and Gunn called for use “only as an alternative second line therapy for those with severe symptoms”. Advocates of EBM are not aware of randomized controlled trials evaluating agomelatine as a second line treatment. Whose interests are served by Ambresin and Gunn when they contradict basic official recommendations? (http://www.elmmb.nhs.uk/formularies/joint-medicines-formulary/4/4-3/)

Agomelatine has been commercialised since 2009. Since then, it has been the subject of a European Medicines Agency Risk Management Plan and reinforced monitoring which confirms agomelatine’s adverse effects profile, already a cause for concern during clinical trials. Some are particularly severe: liver and pancreatic damage, neuropsychological disorders, muscular damage, cutaneous reactions and cardiovascular disorders.(3)

The absence of clinically significant advantages to standard antidepressants combined with limitations (patients taking drugs that inhibit cytochrome P450 1A2 or with impaired liver function), disadvantages (laboratory monitoring of liver function), and such an adverse effects profile indicated that the harm-benefit balance is unfavourable.

Avoid agomelatine, Novartis listed the drug as scheduled for submission to the FDA no earlier than 2012 (Servier sold the rights to market in the United States to Novartis in 2006) but the development for the US market was discontinued in October 2011…

1 Taylor D, Sparshatt A, Varma S, Olofinjana O. Antidepressant efficacy of agomelatine: meta-analysis of published and unpublished studies. BMJ 2014;348:g1888.

2 Ambresin G, Gunn J. Does agomelatine have a place in the treatment of depression? BMJ 2014;348:g2157.

3 Collective. Agomelatine: a review of adverse effects. Prescrire Int 2013; 22: 70-71.

Competing interests: No competing interests

28 March 2014
Alain Braillon
public health
Northern hospital
80000 Amiens. France