Abstract
Analysis of efficacy and tolerability of vortioxetine 20mg/day, and optimal timing of dose adjustment, in patients with major depressive disorder (MDD). Pooled analysis of six randomized, fixed-dose studies of vortioxetine 5 to 20mg/day. Mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score was analyzed by vortioxetine dose using a mixed model for repeated measures. Tolerability was assessed over the 8-week treatment period and from day8 (ie, following dose increase to 20mg/day). Data from three randomized, flexible-dose studies were examined for frequency and timing of dose adjustment. A clear dose-response relationship for vortioxetine was confirmed in terms of improvement in MADRS total score. Significant differences vs placebo were seen for vortioxetine 20mg/day from week2 onwards; vortioxetine 10mg did not separate from placebo until week4. At week8, mean change in MADRS total score from baseline was significantly greater for vortioxetine 20mg/day vs 10mg/day (difference, -1.03 points; P<.05). Incidence of adverse events was not increased in patients who received vortioxetine 20mg/day vs 10mg/day. In flexible-dose studies, dosage was increased to 20mg/day after 1week in 48.0% of patients; final dosage was 20mg/day in 64.3% of patients. Vortioxetine 20mg is significantly more effective than vortioxetine 10mg in patients with MDD, with a similar tolerability profile. In flexible-dose studies, almost half of all patients received 20mg/day after 1week and two-thirds received 20mg/day as their final dosage.
Highlights
Vortioxetine is a multimodal antidepressant with a unique mechanism of action.[1]
Significant differences in mean change from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS) total score between vortioxetine 20 mg/day and placebo were observed from week 2 onwards (P < .05 vs placebo at week 2 and P < .001 vs placebo at weeks 4, 6, and 8)
A statistically significant difference vs placebo for mean change in MADRS total score from baseline after 8 weeks of treatment was seen for vortioxetine 10 mg/day (À3.11, P < .001) and 20 mg/day (À4.32, P < .001) (Table 2)
Summary
Vortioxetine is a multimodal antidepressant with a unique mechanism of action.[1]. First approved by the U.S Food and Drug Administration for the treatment of adults with major depressive disorder (MDD) in 2013, vortioxetine has since been licensed in more than 80 countries worldwide. In 2019, vortioxetine was approved in Japan following completion of a specific local program of randomized controlled studies using fixed doses of 5, 10, and 20 mg/day. Analysis of efficacy and tolerability of vortioxetine 20 mg/day, and optimal timing of dose adjustment, in patients with major depressive disorder (MDD). At week 8, mean change in MADRS total score from baseline was significantly greater for vortioxetine 20 mg/day vs 10 mg/day (difference, À1.03 points; P < .05). In flexible-dose studies, dosage was increased to 20 mg/day after 1 week in 48.0% of patients; final dosage was 20 mg/day in 64.3% of patients. In flexible-dose studies, almost half of all patients received 20 mg/day after 1 week and two-thirds received 20 mg/day as their final dosage
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