Liver Function Test Abnormalities in Depressed Patients Treated with Antidepressants: A Real-World Systematic Observational Study in Psychiatric Settings

Voican, Cosmin Sebastian; Martin, Séverine; Verstuyft, Céline; Perlemuter, Gabriel; Colle, Romain

doi:10.1371/journal.pone.0155234

Cited by 8 publications

(4 citation statements)

References 34 publications

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“…In fact, a study conducted by the French Competent Authority (ANSM) on a cohort of more than 3.8 million subjects has established there was no argument supporting an increased risk of serious hepatic impairment related to the initiation of agomelatine treatment (taken in accordance with the SmPC) compared with selective serotonin reuptake inhibitors [ 48 ]. As hepatic transaminase elevation is seen with most antidepressants, their monitoring during, and on discontinuation of, treatment could be seen in general health care for depressed patients [ 49 ].…”

Section: Discussionmentioning

confidence: 99%

Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France

et al. 2020

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Background and Objectives Non-interventional studies are a valuable source of evidence that is complementary to traditional randomised, blinded and controlled clinical trials, for evaluating antidepressants in a real-world setting. The aim of the present study was to document the use of agomelatine in current medical practice and evaluate its effectiveness and safety in outpatients prescribed agomelatine to treat their current depressive episode. Methods This 12-month observational French study included patients initiating agomelatine treatment. The intensity and severity of depression were assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17) total score and the Clinical Global Impression-Severity of Illness (CGI-S) scale. Patients’ quality of life and functioning were measured using the Quality of Life in Depression Scale and the Sheehan Disability Scale, respectively. The safety measures included emergent adverse events and biological samplings, with a focus on liver acceptability. Results A total of 1484 patients (70% of women; 49.6 ± 15.4 years of age) were enrolled in the study. Most patients (62.3%) were treated with agomelatine for at least 6 months and 28.8% were treated for at least 1 year. Mean HAM-D17 total score and mean CGI-S scores decreased by 13.6 ± 8.1 and 2.1 ± 1.5 points, respectively, from baseline to last visit on agomelatine. Rates of responders (i.e. with a decrease in HAM-D17 total score by at least 50%) and remitters (HAM-D total score < 7) at the last visit were 90.7% and 56.0%, respectively. The mean HAM-D total score decreased after agomelatine withdrawal (− 4.1 ± 6.7) until the last visit. The quality of life and daily functioning of patients improved, while the numbers of days lost and underproductive days decreased over the follow-up period. Safety findings were in accordance with the known information regarding agomelatine. Conclusion In the current medical practice, this study confirms the effectiveness and good tolerability of agomelatine administered for a treatment period in agreement with guideline recommendations. Trial registration number ISRCTN53570733 on 27 August 2010.

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Section: Discussionmentioning

confidence: 99%

Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France

et al. 2020

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“…As consequence, the monitoring of transaminases values required since 2012 with respect of contra indications are the most effective ways of minimising hepatic risk. In general health care, such measures are considered adapted to ensure an optimal follow‐up of depressed patients (Voican et al, 2016). A recent analysis in a cohort comprising 3.2 million new users of antidepressants has shown that, in routine clinical practice, agomelatine did not increase the risk of hospitalisation due to acute liver injury when compared to citalopram (Pladevall‐Vila et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

The safety of agomelatine in standard medical practice in depressed patients: A 26‐week international multicentre cohort study

Gorwood

Bénichou

Moore

et al. 2020

Human Psychopharmacology

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ObjectiveThe present observational cohort study documented the safety of agomelatine in current medical practice in out‐patients suffering from major depressive disorder.MethodThe 6‐month evolution of agomelatine‐treated patients was assessed with a focus on safety (emergent adverse events, liver acceptability), severity of depression using the Clinical Global Impression Severity (CGI‐S) score, and functioning measured by the Sheehan Disability Scale (SDS).ResultsA total of 8453 depressed patients from 761 centres in 6 countries were analysed (female: 67.7%; mean age: 49.1 ± 14.8 years). Adverse events reported were in accordance with the known safety profile of agomelatine. Cutaneous events were reported in 1.7% of the patients and increased hepatic transaminases values were reported in 0.9 % of the patients. The incidence of events related to suicide/self‐injury was 1.0%. Two completed suicides, not related to the study drug, were reported. CGI‐S total scores and SDS sub‐scores improved and numbers of days lost or underproductive decreased over the treatment period.ConclusionsIn standard medical practice, agomelatine treatment was associated with a low incidence of side effects. No unexpected events were reported. A decrease in the severity of the depressive episode and improved functioning were observed.Trial registration nameObservational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients. A prospective, observational (non‐interventional), international, multicentre cohort study.Trial registration numberISRCTN53570733

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“…In our study SGOT and SGPT were elevated in the control group of patients as compared to patient group. [18] …”

Section: Discussionmentioning

confidence: 99%

Levels of Serum Folate and Cobalamine in Clinically Depressed Patients in North Indian Population

Baradia¹,

Kumar²,

Seth³

et al. 2018

AIMDR

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Background: Depression, the most common type of mental illness is the second leading cause of disability worldwide next to CAD. Vitamin B6, folate and vitamin B12 are involved in a series of methylation reaction that produce monoamine neurotransmitters, phospholipids and nucleotide. Therefore the present study was planned to assay the blood levels of vitamin B12 and folate in patients with depression. The objective of this was to study if metabolites are affected by diet and may be helpful in the prevention of depression. Methods: Current study was an experimental case control study, was conducted at Santosh Medical College. A total of 88 cases (44 patients and 44 controls) both males and females in the age between 18 -65 years were included in the study. Hamilton depression rating scale (HDRS) -17 items scale was used to rate the level of depression. Results: In the present study a total of 88 subjects including 45 females and 43 males participated, out of which 44 were control, 24 males and rest 20 were females. Majority 55 patients were of no depression category, 11 were of mild depression category, 10 were of severe depression and rest 9, were of moderate depression category. Mean value of B12 were found lowest in 'moderate' depressed patients (115), than in 'most severe depressed' (137), followed by 'severe' and 'mild' depressed patients category. Value of HDRS increases with severity of depression, it was found lowest in the 'mild' (10.64), then it steadily increases with severity, moderate (15.11), severe (21.20) and most severe (27.55). Conclusion: This study showed that majority of the patients with clinical depression had vitamin B12 deficiency.

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Liver Function Test Abnormalities in Depressed Patients Treated with Antidepressants: A Real-World Systematic Observational Study in Psychiatric Settings

Cited by 8 publications

References 34 publications

Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France

Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France

The safety of agomelatine in standard medical practice in depressed patients: A 26‐week international multicentre cohort study

Levels of Serum Folate and Cobalamine in Clinically Depressed Patients in North Indian Population

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