Stein, D.J.Khoo, J-P.Picarel-Blanchot, F.Olivier, V.Van Ameringen, M.2024-05-052024-05-052021-03Stein DJ, Khoo JP, Picarel-Blanchot F, Olivier V, Van Ameringen M. Efficacy of Agomelatine 25-50 mg for the Treatment of Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder: A Meta-Analysis of Three Placebo-Controlled Studies. Adv Ther. 2021 Mar;38(3):1567-1583. doi: 10.1007/s12325-020-01583-9.10.1007/s12325-020-01583-9https://pubmed.ncbi.nlm.nih.gov/33537871/https://doi.org/10.1007/s12325-020-01583-9https://hdl.handle.net/11288/596060Introduction: The purpose of this study is to investigate the effects of agomelatine on anxious symptoms and functional impairment in a pooled dataset from randomized placebo-controlled trials for generalized anxiety disorder (GAD). Methods: Data from three randomized, placebo-controlled trials that evaluated the efficacy of agomelatine 25-50 mg were pooled. The short-term (12 weeks) efficacy of agomelatine was assessed in regards to (1) anxious symptoms using the Hamilton Anxiety Scale (HAM-A), and (2) functional impairment using the Sheehan Disability Scale (SDS). Meta-analysis using a random effect model was used to assess differences between groups. Remission and response rates for the HAM-A and SDS were calculated, and analyses were repeated in participants with more severe anxiety symptoms. Results: In total, 669 patients (340 on agomelatine; 329 on placebo) were included in the analyses. Compared to placebo, the agomelatine group had a significant reduction in HAM-A total score at week 12 (between group difference: 6.30 ± 2.51, p = 0.012). Significant effects were also found for symptom response on the HAM-A (67.1% of patients on agomelatine vs. 32.5% on placebo) and symptom remission (38.8% of patients on agomelatine vs. 17.3% on placebo). Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005). Significant effects were also found for functional response on the SDS (79.1% of patients on agomelatine vs. 43.2% of placebo) and functional remission (55.2% of patients on agomelatine vs. 25.4% on placebo). All findings for anxious symptoms and functional impairment were confirmed in the subset of more severely anxious patients. Agomelatine was well tolerated by patients. Conclusion: This meta-analysis confirms that agomelatine reduces anxiety symptoms and improves the global functioning of GAD patients.enAttribution 3.0 United Stateshttp://creativecommons.org/licenses/by/3.0/us/AgomelatineFunctioningGeneralized anxiety disorderImpairmentMeta-analysisNeurologyPlaceboShort-termSDG-03 Good health and wealthArticleAdvances in Therapy