The effect of vortioxetine on overall patient functioning in patients with major depressive disorder

Ioana Florea, Henrik Loft, Natalya Danchenko, Benoît Rive, Melanie Brignone, Elizabeth Merikle, Paula L Jacobsen, David V Sheehan, Ioana Florea, Henrik Loft, Natalya Danchenko, Benoît Rive, Melanie Brignone, Elizabeth Merikle, Paula L Jacobsen, David V Sheehan

Abstract

Background: The objectives of this meta-analysis of data from randomized, placebo-controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD).

Methods: Data from nine short-term (6/8 weeks) pivotal studies that included patient functioning assessments were included in this random-effects meta-analysis, which used aggregated study-level data for all therapeutic vortioxetine doses and a mixed-effect model for repeated measures using the full analysis set.

Results: A total of 4,216 patients received ≥1 dose of study treatment (1,522 placebo, 2,694 vortioxetine 5-20 mg/day). At study end, the meta-analysis showed improvement for vortioxetine versus placebo (n = 911) in SDS total score (vortioxetine 5 mg, n =564, change from baseline versus placebo [Δ] -0.24, p = NS; 10 mg, n =445, Δ -1.68, p ≤.001; 15 mg, n =204, Δ -0.91, p = NS; 20 mg, n =340, Δ -1.94, p ≤.01). Functional remission (SDS total score ≤6) was observed with vortioxetine 10 mg (n =170/573; odds ratio [OR] relative to placebo 1.7, p <.001) and 20 mg (n =144/447; OR 1.6, p <.05), but not 5 mg (n =207/757; OR 1.1, p = NS) or 15 mg (n =92/295; OR 1.3, p = NS).

Conclusion: Vortioxetine 5-20 mg for 6/8 weeks improved overall patient functioning in patients with MDD. Relative to placebo, vortioxetine 10 and 20 mg demonstrated significant improvement in SDS total score and functional remission.

Keywords: Sheehan Disability Scale; functional impairment; major depressive disorder; quality of life; vortioxetine.

Figures

Figure 1
Figure 1
Meta‐analysis of the difference from placebo in Sheehan Disability Scale (SDS) total score change from baseline at week 6/8: Total population (full analysis set, mixed‐effect model for repeated measure). CRF, case report form; VOR, vortioxetine.*Primary meta‐analysis
Figure 2
Figure 2
Meta‐analysis of the difference from placebo in Sheehan Disability Scale (SDS) single‐item scores change from baseline at week 6/8: Total population (full analysis set, mixed‐effect model for repeated measure). VOR, vortioxetine
Figure 3
Figure 3
Meta‐analysis of the difference from placebo in Sheehan Disability Scale (SDS) total score change from baseline at week 6/8: Patients with baseline Montgomery‐Åsberg Depression Rating Scale (MADRS) ≥30 (full analysis set, mixed‐effect model for repeated measure). VOR, vortioxetine
Figure 4
Figure 4
Meta‐analysis of the difference from placebo in Sheehan Disability Scale (SDS) total score change from baseline at week 6/8: Patients with baseline SDS ≥18 (full analysis set, mixed‐effect model for repeated measure). VOR, vortioxetine
Figure 5
Figure 5
Meta‐analysis of the difference from placebo in Sheehan Disability Scale (SDS) total score change from baseline at week 6/8: Patients with baseline SDS ≥18 and baseline Montgomery‐Åsberg Depression Rating Scale (MADRS) ≥30 (full analysis set, mixed‐effect model for repeated measure). VOR, vortioxetine
Figure 6
Figure 6
Meta‐analysis of the difference from placebo in Sheehan Disability Scale (SDS) total score change from baseline at week 6/8: Patients with baseline Hamilton Anxiety Rating Scale (HAM‐A) ≥20 (full analysis set, mixed‐effect model for repeated measure). VOR, vortioxetine
Figure 7
Figure 7
Meta‐analysis of remission rates (Sheehan Disability Scale [SDS] ≤6) at week 6/8: Patients with baseline SDS >6 (full analysis set, last observation carried forward). VOR, vortioxetine. *Overall rate for meta‐analysis placebo population

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