Efficacy and tolerability of vortioxetine vs agomelatine, categorized by previous treatment, in patients with major depressive disorder switched after an inadequate response
Journal of Psychiatric Research Mar 08, 2018
Papakostas GI, et al. - Researchers here aimed at evaluating if efficacy and tolerability of switching to vortioxetine are independent of previous SSRI or SNRI treatment in patients who had been inadequately treated for their current major depressive episode. Findings revealed statistical superiority of vortioxetine to agomelatine for patients previously treated with SSRIs and demonstrated statistically not significant improvements for the smaller SNRI subgroup. Vortioxetine was as equally well tolerated as agomelatine. Evidence from the subgroup analyses supported switching of inadequate responders to vortioxetine.
Methods
- Researchers randomized patients from a double-blind, 12-week comparator study (1:1) to vortioxetine (10–20 mg/day) or agomelatine (25–50 mg/day).
- Change from baseline to week 8 in MADRS total score analyzed by MMRM was the pre-defined primary efficacy endpoint.
- They conducted an ANCOVA-LOCF as a sensitivity analysis.
- They repeated these analyses in subgroups according to previous antidepressant treatment.
Results
- Vortioxetine (n = 252) was markedly superior to agomelatine (n = 241) by -2.2 MADRS points (p < 0.01) at week 8 in the overall population.
- With an SSRI (citalopram, escitalopram, paroxetine, sertraline), nearly 77% (n = 189/vortioxetine, n = 188/agomelatine) were previously treated and with an SNRI (duloxetine, venlafaxine), nearly 23% (n = 62/vortioxetine, n = 52/agomelatine) were previously treated.
- All subgroups were similar in terms of baseline characteristics.
- At weeks 8 and 12, treatment differences (MMRM) in MADRS total score were -2.6 and -2.3 (n = 164/vortioxetine, n = 150/agomelatine) (p < 0.01) for patients switching from an SSRI; the values were -1.8 and -1.5, respectively, (n = 56/vortioxetine, n = 40/agomelatine) (p > 0.05) for patients switching from an SNRI; non-significant improvements were seen for each of the 6 previous antidepressants.
- They observed that improvements in HAM-A, CGI-I, and EQ-5D scales were significant for the SSRI subgroup and non-significant for the SNRI subgroup.
- Regardless of previous SSRI or SNRI treatment, withdrawal and adverse event rates were similar.
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