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

Abstract

Introduction 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. Supplementary Information The online version of this article (10.1007/s12325-020-01583-9) contains supplementary material, which is available to authorized users.

Agomelatine for the treatment of generalized anxiety disorder: focus on its distinctive mechanism of action

“…49 – 51 The positive outcome of these respective studies was recently reprised by a pooled meta-analysis that underpinned evidence for robust efficacy both in alleviating symptoms and in enhancing global patient function. 27 , 28 Efficacy of agomelatine was comparable to the active control, escitalopram (an SSRI), and secondary analysis supported effectiveness in severe GAD (Hamilton Anxiety Scale > 21). 28 , 49 – 52 Although its precise onset of efficacy remains to be further characterized, clinical studies suggest activity within the 1–3 weeks after commencing administration in at least some patients.…”

“… 26 Potential therapeutic efficacy in GAD was subsequently assessed within the framework of controlled clinical trials over 2008 to 2018, and these observations constitute the basis for a dossier in preparation for submission to the appropriate Health Authorities. 27 , 28 These observations are consecutively summarized below and then its potential mechanisms of action are considered in greater detail.…”

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“…The primary efficacy measure was the treatment response, defined according to other studies, as at least a 20% reduction in PANSS total score from baseline to the endpoint [ 53 ]. Secondary efficacy variables included the response according to a decrease in the total score ≥ 50% in HDRS [ 54 ], HAM-A [ 55 ], and YMRS [ 56 ] scales.…”

The clinical characterization of the adult patient with an anxiety or related disorder aimed at personalization of management

“…However, there has been relatively little subsequent evidence to support the selective response of psychic and somatic symptoms to different pharmacotherapies. A range of medications that are efficacious for GAD improve both psychic and somatic symptoms [76][77][78][79] .…”