The Antidepressant Agomelatine in Daily Practice: Results of the Non-Interventional Study VIVALDI

Laux, G.

doi:10.1055/s-0032-1309003

Cited by 36 publications

(23 citation statements)

References 7 publications

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“…Similar efficacy of agomelatine (25–50 mg daily) in severe depression was shown in the 12-week, non-interventional effectiveness open-label study VIVALDI (ValdoxAn Improves depressiVe symptoms And normaLizes circaDIan rhythms) 48. Prior to this study, 70.2% of patients were on other antidepressants.…”

Section: Efficacysupporting

confidence: 63%

Efficacy and tolerability of agomelatine in the treatment of depression

Plesničar¹

2014

PPA

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Depression is a severe and usually recurrent mental disorder which often leads to a significant impairment of everyday functioning, a reduced quality of life, and also great suffering of the patients. The treatment of a depressive disorder is not only limited to acute treatment; it also requires prolonged management. Patient compliance is of utmost importance. Unpleasant adverse effects and their impact on everyday living often lead to a premature discontinuation of antidepressant treatment and result in an unfavorable treatment outcome. The new antidepressant agomelatine, a melatonergic MT1/MT2 agonist and 5-HT2C receptor antagonist, has exhibited good antidepressant efficacy in acute, short-term, and long-term treatment. The adverse effect profile of agomelatine has been proven to be favorable and comparable to placebo, which is very important for good treatment compliance and adherence.

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Section: Efficacysupporting

confidence: 63%

Efficacy and tolerability of agomelatine in the treatment of depression

Plesničar¹

2014

PPA

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“…In the analyzed population of the present paper the vast majority demonstrated asymptomatic increase of liver enzymes. Although an AGMrelated elevation of the γ-GT serum levels was reported to occur infrequently according to results of the large VIVALDI study [ 42 ] , in the present analysis increased γ-GT serum levels were involved in 81 % of all reports of AGM-related elevations of liver enzymes. 10 % of the included cases developed AGM-related toxic hepatitis, underscoring the potential of AGM to cause serious ADR.…”

Section: Forms Of Agm-related Hepatotoxic Adrcontrasting

confidence: 55%

“…Considering AGM-related hepatotoxic ADR there is a considerable discrepancy between the common clinical knowledge of the potential of AGM to cause hepatotoxic ADR and the factual availability of published data regarding AGM-related hepatotoxicity [ 41 ] . Nevertheless, results of a recent non-interventional, observational study involving n = 3 317 depressed outpatients treated with AGM for 12 weeks indicated a comparatively low incidence of elevation of liver enzymes (> 3-fold upper the limit of normal range) of 0.2 % [ 42 ] . Still, most likely as a consequence of increasing empirical evidence for AGM-related hepatotoxicity in terms of unpublished reports of hepatotoxic ADR, the manufacturer of AGM released a safety warning pointing out to the possibility of AGM-related hepatotoxic ADR in October 2012, and the prescribing information has been modifi ed accordingly.…”

mentioning

confidence: 97%

Agomelatine and Hepatotoxicity: Implications of Cumulated Data Derived from Spontaneous Reports of Adverse Drug Reactions

et al. 2013

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Considering the antidepressant agomelatine (AGM) there is a discrepancy between the widespread knowledge of the potential of AGM to cause hepatotoxic adverse drug reactions (ADR) and the availability of corresponding published data. This impedes an adequate assessment of the hepatotoxicity profile of AGM. We conducted a query of the database of a German Medical Regulatory Body (BfArM) and analyzed spontaneous reports of hepatotoxic ADR. We identified n=58 cases of AGM-related hepatotoxic ADR. Most frequent ADR was asymptomatic increase of liver enzymes (79%); n=6 patients (10%) with AGM-related toxic hepatitis were reported. Characteristics of patients: female sex (69%), age > 50 years (mean 54 years), polypharmacy (57%), and presence of cardiovascular risk factors (58.5%). Most of the hepatotoxic ADR (90%) were reported to have improved/recovered after discontinuation of AGM. Our evaluation suggests that AGM features a potential to cause severe forms of hepatotoxicity and emphasizes that a pre-existing liver disease is a contraindication for treatment with AGM. Secondly, increased age, female sex and polypharmacy may be risk factors for the development of AGM-related hepatotoxic ADR.

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“…In a 12-week study of patients by Laux and the VIVALDI Study Group 2 [42], significant elevations in liver enzymes specifically reported as an adverse drug reaction were noted in eight patients (0.2%). For five patients, it was possible for the authors to assess the evolution of abnormal liver enzyme values as both baseline and at least one follow-up value were available.…”

Section: Reviewmentioning

confidence: 99%

A systematic review of agomelatine-induced liver injury

Freiesleben

Furczyk

2015

J Mol Psychiatr

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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.

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The Antidepressant Agomelatine in Daily Practice: Results of the Non-Interventional Study VIVALDI

Cited by 36 publications

References 7 publications

Efficacy and tolerability of agomelatine in the treatment of depression

Efficacy and tolerability of agomelatine in the treatment of depression

Agomelatine and Hepatotoxicity: Implications of Cumulated Data Derived from Spontaneous Reports of Adverse Drug Reactions

A systematic review of agomelatine-induced liver injury

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