Limits...
Profile of vortioxetine in the treatment of major depressive disorder: an overview of the primary and secondary literature.

Kelliny M, Croarkin PE, Moore KM, Bobo WV - Ther Clin Risk Manag (2015)

Bottom Line: This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults.Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants.Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.

ABSTRACT
This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults. The efficacy of vortioxetine for treating MDD in adults is supported by eight positive short-term (6- to 12-weeks) randomized, placebo-controlled trials, and one positive randomized, double-blind, 52-week relapse prevention trial. Based on pooled data from short-term randomized trials and from longer-term studies, vortioxetine appears to be well tolerated and to have a low incidence of adverse effects on sexual functioning. Vortioxetine also appears to be effective for treating symptoms of MDD in the elderly based on the results of one randomized trial for which recruitment was focused on this specific population. Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants. Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

No MeSH data available.


Related in: MedlinePlus

Frequency of selected treatment-emergent adverse effects, based on pooled data from short-term randomized trials of vortioxetine in adults with major depression.Notes: This graph displays the pooled frequency of selected treatment-emergent adverse effects by vortioxetine dose from short-term (6–8 weeks) placebo-controlled studies in adults with major depression (2,616 were treated with vortioxetine), as reported in the vortioxetine drug label. Only selected adverse effects that occurred in ≥2% of vortioxetine-treated patients at any dose and occurred ≥2% more frequently with vortioxetine than with placebo are shown.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4542474&req=5

f2-tcrm-11-1193: Frequency of selected treatment-emergent adverse effects, based on pooled data from short-term randomized trials of vortioxetine in adults with major depression.Notes: This graph displays the pooled frequency of selected treatment-emergent adverse effects by vortioxetine dose from short-term (6–8 weeks) placebo-controlled studies in adults with major depression (2,616 were treated with vortioxetine), as reported in the vortioxetine drug label. Only selected adverse effects that occurred in ≥2% of vortioxetine-treated patients at any dose and occurred ≥2% more frequently with vortioxetine than with placebo are shown.

Mentions: Pooled randomized trial data addressing the incidence of specific adverse effects are provided in the vortioxetine drug label (Figure 2), which summarizes safety data from 4,746 patients (aged 19–88 years) with MDD enrolled in short-term randomized trials.45 Of these, 2,616 received treatment with vortioxetine (5–20 mg/day) over 6–8 weeks. The most common adverse effect attributable to vortioxetine treatment was nausea, the frequency of which increased in a dose-dependent manner from 21% at 5 mg/day to 32% at 15 mg and 20 mg/day, and was substantially higher than that on placebo (9%) across all vortioxetine doses (Figure 1). Although treatment-emergent nausea tended to be mild or moderate in intensity and persisted for a median duration of 2 weeks, it was still the most common adverse effect leading to vortioxetine discontinuation. Other commonly reported adverse effects across vortioxetine doses included diarrhea (7%–10%), dizziness (6%–9%), vomiting (3%–6%), dry mouth (6%–8%), constipation (3%–6%), and pruritus (1%–3%). With the exception of nausea, vomiting, and constipation, the incidence rates for these adverse effects were comparable between vortioxetine and placebo.


Profile of vortioxetine in the treatment of major depressive disorder: an overview of the primary and secondary literature.

Kelliny M, Croarkin PE, Moore KM, Bobo WV - Ther Clin Risk Manag (2015)

Frequency of selected treatment-emergent adverse effects, based on pooled data from short-term randomized trials of vortioxetine in adults with major depression.Notes: This graph displays the pooled frequency of selected treatment-emergent adverse effects by vortioxetine dose from short-term (6–8 weeks) placebo-controlled studies in adults with major depression (2,616 were treated with vortioxetine), as reported in the vortioxetine drug label. Only selected adverse effects that occurred in ≥2% of vortioxetine-treated patients at any dose and occurred ≥2% more frequently with vortioxetine than with placebo are shown.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4542474&req=5

f2-tcrm-11-1193: Frequency of selected treatment-emergent adverse effects, based on pooled data from short-term randomized trials of vortioxetine in adults with major depression.Notes: This graph displays the pooled frequency of selected treatment-emergent adverse effects by vortioxetine dose from short-term (6–8 weeks) placebo-controlled studies in adults with major depression (2,616 were treated with vortioxetine), as reported in the vortioxetine drug label. Only selected adverse effects that occurred in ≥2% of vortioxetine-treated patients at any dose and occurred ≥2% more frequently with vortioxetine than with placebo are shown.
Mentions: Pooled randomized trial data addressing the incidence of specific adverse effects are provided in the vortioxetine drug label (Figure 2), which summarizes safety data from 4,746 patients (aged 19–88 years) with MDD enrolled in short-term randomized trials.45 Of these, 2,616 received treatment with vortioxetine (5–20 mg/day) over 6–8 weeks. The most common adverse effect attributable to vortioxetine treatment was nausea, the frequency of which increased in a dose-dependent manner from 21% at 5 mg/day to 32% at 15 mg and 20 mg/day, and was substantially higher than that on placebo (9%) across all vortioxetine doses (Figure 1). Although treatment-emergent nausea tended to be mild or moderate in intensity and persisted for a median duration of 2 weeks, it was still the most common adverse effect leading to vortioxetine discontinuation. Other commonly reported adverse effects across vortioxetine doses included diarrhea (7%–10%), dizziness (6%–9%), vomiting (3%–6%), dry mouth (6%–8%), constipation (3%–6%), and pruritus (1%–3%). With the exception of nausea, vomiting, and constipation, the incidence rates for these adverse effects were comparable between vortioxetine and placebo.

Bottom Line: This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults.Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants.Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.

ABSTRACT
This article reviews the pharmacological profile and available efficacy and tolerability/safety data for vortioxetine, one of the most recent antidepressant drugs to be approved in the USA for the treatment of major depressive disorder (MDD) in adults. The efficacy of vortioxetine for treating MDD in adults is supported by eight positive short-term (6- to 12-weeks) randomized, placebo-controlled trials, and one positive randomized, double-blind, 52-week relapse prevention trial. Based on pooled data from short-term randomized trials and from longer-term studies, vortioxetine appears to be well tolerated and to have a low incidence of adverse effects on sexual functioning. Vortioxetine also appears to be effective for treating symptoms of MDD in the elderly based on the results of one randomized trial for which recruitment was focused on this specific population. Nevertheless, effectiveness studies that directly compare the clinical effects of vortioxetine with other established antidepressant drugs are lacking, and there is no evidence as yet that vortioxetine is more clinically effective than other types of antidepressants. Some preliminary suggestions concerning the place of vortioxetine among the broad range of pharmacological treatments for adults with MDD are provided.

No MeSH data available.


Related in: MedlinePlus