The efficacy and safety of multiple doses of vortioxetine for generalized anxiety disorder: a meta-analysis - PubMed (original) (raw)

The efficacy and safety of multiple doses of vortioxetine for generalized anxiety disorder: a meta-analysis

Jie Fu et al. Neuropsychiatr Dis Treat. 2016.

Abstract

Objective: Vortioxetine is a novel antidepressant approved for the treatment of major depressive disorder by the US Food and Drug Administration in September 2013. This meta-analysis assessed the efficacy and safety of different doses of vortioxetine for generalized anxiety disorder of adults.

Methods: PubMed, Cochrane Library, PsycINFO, and Clinical Trials databases were searched from 2000 through 2015. The abstracts of the annual meetings of the American Psychiatric Association and previous reviews were searched to identify additional studies. The search was limited to individual randomized controlled trials (RCTs), and there was no language restriction. Four RCTs met the selection criteria. These studies included 1,843 adult patients. Results were expressed as odds ratios (ORs) and 95% confidence intervals (CIs). The data were pooled with a random-effects or fixed-effects model.

Results: The results showed that multiple doses (2.5, 5, and 10 mg/d) of vortioxetine did not significantly improve the generalized anxiety disorder symptoms compared to placebo (OR=1.16, 95% CI=0.84-1.60, Z=0.89, P=0.38; OR=1.41, 95% CI=0.82-2.41, Z=1.25, P=0.21; OR=1.05, 95% CI=0.76-1.46, Z=0.32, P=0.75, respectively). We measured the efficacy of 2.5 mg/d vortioxetine compared to 10 mg/d, and no significant differences were observed. The common adverse effects included nausea and headache. With increased dose, nausea was found to be more frequent in the vortioxetine (5 and 10 mg/d) group (OR=2.99, 95% CI=1.31-6.84, Z=2.60, P=0.009; OR=2.80, 95% CI=1.85-4.25, Z=4.85, P<0.00001, respectively), but no significant differences were observed for headache.

Conclusion: The results showed no significant improvement in the treatment of generalized anxiety disorder for vortioxetine compared to placebo, and nausea was more frequent with higher doses. So the current evidences do not support using vortioxetine for the treatment of generalized anxiety disorder. Few RCTs were included in our meta-analysis, and more studies are needed to verify our results in the future.

Keywords: generalized anxiety disorder; meta-analysis; placebo; vortioxetine.

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Figures

Figure 1

Figure 1

Search flow for the trial identification and selection process. Abbreviations: APA, American Psychiatric Association; RCT, randomized control trial.

Figure 2

Figure 2

Odds ratios (ORs) and 95% confidence intervals (CIs) of the individual studies and the pooled data for the included studies comparing the response rates between the groups treated with multiple doses of vortioxetine and placebo. Notes: (A) 2.5 mg/d vortioxetine vs placebo, (B) 5 mg/d vortioxetine vs placebo, (C) 10 mg/d vortioxetine vs placebo, and (D) 2.5 mg/d vortioxetine vs 10 mg/d vortioxetine. Abbreviations: M–H, Mantel–Haenszel; df, degrees of freedom.

Figure 2

Figure 2

Odds ratios (ORs) and 95% confidence intervals (CIs) of the individual studies and the pooled data for the included studies comparing the response rates between the groups treated with multiple doses of vortioxetine and placebo. Notes: (A) 2.5 mg/d vortioxetine vs placebo, (B) 5 mg/d vortioxetine vs placebo, (C) 10 mg/d vortioxetine vs placebo, and (D) 2.5 mg/d vortioxetine vs 10 mg/d vortioxetine. Abbreviations: M–H, Mantel–Haenszel; df, degrees of freedom.

Figure 3

Figure 3

Odds ratios (ORs) and 95% confidence intervals (CIs) of the individual studies and the pooled data for the included studies comparing the nausea rates between the groups treated with multiple doses of vortioxetine and placebo. Notes: (A) 2.5 mg/d vortioxetine vs placebo, (B) 5 mg/d vortioxetine vs placebo, and (C) 10 mg/d vortioxetine vs placebo. Abbreviations: M–h, Mantel–haenszel; df, degrees of freedom.

Figure 4

Figure 4

Odds ratios (ORs) and 95% confidence intervals (CIs) of the individual studies and the pooled data for the included studies comparing the headache rates between the groups treated with multiple doses of vortioxetine and placebo. Notes: (A) 2.5 mg/d vortioxetine vs placebo, (B) 5 mg/d vortioxetine vs placebo, and (C) 10 mg/d vortioxetine vs placebo. Abbreviations: M–H, Mantel–Haenszel; df, degrees of freedom.

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References

    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 5. Arlington, VA: American Psychiatric Publishing; 2013.
    1. Goorden M, Muntingh A, van Marwijk H, et al. Cost utility analysis of a collaborative stepped care intervention for panic and generalized anxiety disorders in primary care. J Psychosom Res. 2014;77(1):57–63. - PubMed
    1. Latas M, Stojković T, Bosnjak MC, et al. How do we treat generalized anxiety disorder? Srp Arh Celok Lek. 2014;142(3–4):204–212. - PubMed
    1. Bandelow B, Sher L, Bunevicius R, et al. Guidelines for the pharmacological treatment of anxiety disorders, obsessive-compulsive disorder and posttraumatic stress disorder in primary care. Int J Psychiatry Clin Pract. 2012;16:77e84. - PubMed
    1. Baldwin DS, Anderson IM, Nutt DJ, et al. Evidence-based pharmacological treatment of anxiety disorders, posttraumatic stress disorder and obsessive-compulsive disorder: a revision of the 2005 guidelines from the British Association for Psychopharmacology. J Psychopharmacol. 2014;28:403e39. - PubMed

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