Vortioxetine treatment for generalised anxiety disorder: a meta-analysis of anxiety, quality of life and safety outcomes

Abstract

Objectives: The aim of this study was to investigate the efficacy, tolerability, safety, and impact on quality of life (QoL) and functional status of vortioxetine treatment for patients with generalised anxiety disorder (GAD) by performing a meta-analysis of randomised controlled trials (RCTs).

Design: Systematic review and meta-analysis.

Data sources: Data mining was conducted in January 2019 across PubMed, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials Cochrane Library, Web of science and ClinicalTrials.gov.

Eligibility criteria for selecting studies: All published RCTs, which assessed the effect of vortioxetine treatment for patients with GAD when compared with a placebo group, were included.

Data extraction and synthesis: Relevant data were extracted and synthesised narratively. Results were expressed as standardised mean differences or ORs with 95% CIs.

Results: Our meta-analysis showed that multiple doses (2.5, 5 and 10 mg/day) of vortioxetine did not significantly improve the response rates, compared with placebo (OR 1.16, 95% CI 0.84 to 1.60, p=0.38; OR 1.41, 95% CI 0.82 to 2.41, p=0.21; and OR 1.05, 95% CI 0.76 to 1.46, p=0.75). Moreover, there was no statistically significant difference regarding the remission rates, discontinuation for any reason rates, discontinuation due to adverse events rates, Short-Form 36 Health Survey scores or Sheehan Disability Scale scores between administration of multiple doses (2.5, 5 and 10 mg/day) of vortioxetine and placebo.

Conclusions: Although our results suggest that vortioxetine did not improve the GAD symptoms, QoL and functional status impairment of patients with GAD, it was safe and well tolerated. Clinicians should interpret and translate our data with caution, as the meta-analysis was based on a limited number of RCTs.

Keywords: generalized anxiety disorder; meta-analysis; multimodal therapy; vortioxetine.

Figure 1

ORs and 95% CIs of the individual studies and the pooled data, comparing the response rates between the vortioxetine-treated and placebo groups. (A) 2.5 mg/day vortioxetine vs placebo, (B) 5 mg/day vortioxetine versus placebo and (C) 10 mg/day vortioxetine versus placebo. M-H, Mantel-Haenszel; IV, Inverse Variance.

Figure 2

ORs and 95% CIs of the individual studies and the pooled data, comparing the remission rates between the vortioxetine and placebo groups. (A) 2.5 mg/day vortioxetine versus placebo, (B) 5 mg/day vortioxetine versus placebo and (C) 10 mg/day vortioxetine versus placebo. M-H, Mantel-Haenszel; IV, Inverse Variance.

Figure 3

Standardised mean differences and 95% CIs of the individual studies and the pooled data, comparing the mean change from baseline in total scores on the HAM-A, between the vortioxetine and placebo groups. (A) 2.5 mg/day vortioxetine versus placebo, (B) 5 mg/day vortioxetine versus placebo and (C) 10 mg/day vortioxetine versus placebo. HAM-A, Hamilton Anxiety Rating Scale; M-H, Mantel-Haenszel; IV, Inverse Variance.

Figure 4

Standardised mean differences and 95% CIs of the individual studies and the pooled data, comparing the Short-Form 36 Health Survey scores between the vortioxetine and placebo groups. (A) 2.5 mg/day vortioxetine versus placebo, (B) 5 mg/day vortioxetine versus placebo and (C) 10 mg/day vortioxetine versus placebo. M-H, Mantel-Haenszel; IV, Inverse Variance.

Figure 5

Standardised mean differences and 95% CIs of the individual studies and the pooled data, comparing the Sheehan Disability Scale scores between the vortioxetine and placebo groups. (A) 2.5 mg/day vortioxetine versus placebo, (B) 5 mg/day vortioxetine versus placebo and (C) 10 mg/day vortioxetine versus placebo. M-H, Mantel-Haenszel; IV, Inverse Variance.