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A meta-analysis of the efficacy of vortioxetine in patients with major depressive disorder (MDD) and high levels of anxiety symptoms

A meta-analysis of the efficacy of vortioxetine in patients with major depressive disorder (MDD) and high levels of anxiety symptoms
A meta-analysis of the efficacy of vortioxetine in patients with major depressive disorder (MDD) and high levels of anxiety symptoms
Background: Comorbid anxiety is common in major depressive disorder (MDD) and more difficult to treat than depression without anxiety. This analysis assessed the efficacy, safety, and tolerability of vortioxetine in MDD patients with high levels of anxiety (baseline Hamilton Anxiety Rating Scale [HAM-A] total score ?20).

Methods: Efficacy was assessed using an aggregated, study-level meta-analysis of 10 randomized, placebo-controlled, 6/8-week trials of vortioxetine 5-20 mg/day in adults (18-75 years), with a study in elderly patients (?65 years) analyzed separately. Outcome measures included mean differences from placebo in change from baseline to endpoint (?) in the Montgomery-Åsberg Depression Rating Scale (MADRS), HAM-A total, and HAM-A subscales. Safety and tolerability were assessed by treatment-emergent adverse events (TEAEs).

Results: A total of 1497 (48.6%) vortioxetine-treated and 860 (49.1%) placebo-treated patients had baseline HAM-A?20. There were significant differences from placebo in MADRS (vortioxetine 5 mg/day, n=415, ??2.68, P=0.005; 10 mg/day, n=373, ??3.59, P<0.001; 20 mg/day, n=207, ??4.30, P=0.005) and HAM-A total (5 mg/day, n=419, ??1.64, P=0.022; 10 mg/day, n=373, ??2.04, P=0.003; 20 mg/day, n=207, ??2.19, P=0.027). There were significantly greater improvements versus placebo on the HAM-A psychic subscale for all doses. The most common TEAEs (?5.0%) were nausea, headache, dizziness, dry mouth, diarrhea, nasopharyngitis, constipation, and vomiting. Incidence of serious TEAEs was 1.3% (placebo) and ?1.3% (vortioxetine, across doses).

Limitations: Study heterogeneity limits this analysis. Patients with baseline HAM-A?20 were not directly compared to baseline HAM-A<20 or total MDD population.

Conclusions: Vortioxetine was efficacious in reducing depressive and anxiety symptoms in patients with MDD and high levels of anxiety.
0165-0327
140-150
Baldwin, David S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Jacobsen, Paula
99949509-58f7-493d-90a6-54c184b0ada5
Florea, Ioana
db1b3456-16d0-4777-9870-00eea2b23cdb
Zhong, Wei
35c19165-873e-4d99-8877-eb590ec3e90f
Nomikos, George G.
f1aae7f9-4eba-4afb-a7e9-45d4e51d3f7b
Baldwin, David S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Jacobsen, Paula
99949509-58f7-493d-90a6-54c184b0ada5
Florea, Ioana
db1b3456-16d0-4777-9870-00eea2b23cdb
Zhong, Wei
35c19165-873e-4d99-8877-eb590ec3e90f
Nomikos, George G.
f1aae7f9-4eba-4afb-a7e9-45d4e51d3f7b

Baldwin, David S., Jacobsen, Paula, Florea, Ioana, Zhong, Wei and Nomikos, George G. (2016) A meta-analysis of the efficacy of vortioxetine in patients with major depressive disorder (MDD) and high levels of anxiety symptoms. Journal of Affective Disorders, 206, 140-150. (doi:10.1016/j.jad.2016.07.015).

Record type: Article

Abstract

Background: Comorbid anxiety is common in major depressive disorder (MDD) and more difficult to treat than depression without anxiety. This analysis assessed the efficacy, safety, and tolerability of vortioxetine in MDD patients with high levels of anxiety (baseline Hamilton Anxiety Rating Scale [HAM-A] total score ?20).

Methods: Efficacy was assessed using an aggregated, study-level meta-analysis of 10 randomized, placebo-controlled, 6/8-week trials of vortioxetine 5-20 mg/day in adults (18-75 years), with a study in elderly patients (?65 years) analyzed separately. Outcome measures included mean differences from placebo in change from baseline to endpoint (?) in the Montgomery-Åsberg Depression Rating Scale (MADRS), HAM-A total, and HAM-A subscales. Safety and tolerability were assessed by treatment-emergent adverse events (TEAEs).

Results: A total of 1497 (48.6%) vortioxetine-treated and 860 (49.1%) placebo-treated patients had baseline HAM-A?20. There were significant differences from placebo in MADRS (vortioxetine 5 mg/day, n=415, ??2.68, P=0.005; 10 mg/day, n=373, ??3.59, P<0.001; 20 mg/day, n=207, ??4.30, P=0.005) and HAM-A total (5 mg/day, n=419, ??1.64, P=0.022; 10 mg/day, n=373, ??2.04, P=0.003; 20 mg/day, n=207, ??2.19, P=0.027). There were significantly greater improvements versus placebo on the HAM-A psychic subscale for all doses. The most common TEAEs (?5.0%) were nausea, headache, dizziness, dry mouth, diarrhea, nasopharyngitis, constipation, and vomiting. Incidence of serious TEAEs was 1.3% (placebo) and ?1.3% (vortioxetine, across doses).

Limitations: Study heterogeneity limits this analysis. Patients with baseline HAM-A?20 were not directly compared to baseline HAM-A<20 or total MDD population.

Conclusions: Vortioxetine was efficacious in reducing depressive and anxiety symptoms in patients with MDD and high levels of anxiety.

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More information

Accepted/In Press date: 6 July 2016
e-pub ahead of print date: 7 July 2016
Published date: December 2016
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 397923
URI: https://eprints.soton.ac.uk/id/eprint/397923
ISSN: 0165-0327
PURE UUID: 78e803b2-5131-4d9c-a33d-c1f406219d7a

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Date deposited: 12 Jul 2016 08:58
Last modified: 10 Dec 2019 06:28

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Contributors

Author: Paula Jacobsen
Author: Ioana Florea
Author: Wei Zhong
Author: George G. Nomikos

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