A systematic review of agomelatine-induced liver injury

Journal of Molecular Psychiatry

Karolina Furczyk¹  Silka Dawn Freiesleben¹ 

[1] Department of Psychiatry, University of Rostock, Gehlsheimerstraße 20, Rostock, 18147, Germany

关键词: Melatonin analogue;    Hepatotoxicity;    Depression;    Clinical recommendations;    Antidepressant;    Adverse event;   

Others  :  1180745
DOI  :  10.1186/s40303-015-0011-7

 received in 2014-11-30, accepted in 2015-04-11,  发布年份 2015

【 摘 要 】

Agomelatine is an antidepressant with a unique mechanism of action. Since its marketing in 2009, concerns have been raised regarding its potential to induce liver injury. The authors therefore address the need to comprehensively evaluate the potential risk posed by agomelatine of inducing liver injury by reviewing data from published and unpublished clinical trials in both the pre- and postmarketing settings, as well as data from non-interventional studies, pharmacovigilance database reviews and one case report. Recommendations for clinicians are also provided.

In this review, agomelatine was found to be associated with higher rates of liver injury than both placebo and the four active comparator antidepressants used in the clinical trials for agomelatine, with rates as high as 4.6% for agomelatine compared to 2.1% for placebo, 1.4% for escitalopram, 0.6% for paroxetine, 0.4% for fluoxetine, and 0% for sertraline. The review also provides evidence for the existence of a positive relationship between agomelatine dose and liver injury. Furthermore, rates of liver injury were found to be lower in non-interventional studies. Findings from pharmacovigilance database reviews and one case report also highlight the risk of agomelatine-induced liver injury.

As agomelatine does pose a risk of liver injury, clinicians must carefully monitor liver function throughout treatment. However, agomelatine’s unique mechanism of action and favourable safety profile render it a valuable treatment option.

A quantitative analysis of agomelatine-induced liver injury is lacking in the literature and would be welcomed.

【 授权许可】

   
2015 Freiesleben and Furczyk et al.; licensee BioMed Central.

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