CNS spectrums · 2017
Efficacy of vortioxetine in working patients with generalized anxiety disorder.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Christensen Michael Cronquist, Loft Henrik, Florea Ioana, McIntyre Roger S
Аннотация
BACKGROUND: Vortioxetine is an approved antidepressant that has also demonstrated positive effects on anxiety symptoms in subjects with generalized anxiety disorder (GAD). This post-hoc analysis evaluates the efficacy of vortioxetine in GAD subjects who are working and/or pursuing an education.
METHODS: In study NCT00744627, 301 GAD subjects were randomized to vortioxetine 5 mg or placebo for 8 weeks. Efficacy measures included the Hamilton Anxiety Rating Scale (HAM-A) total score, response/remission, global functioning (Sheehan Disability Scale [SDS]), and quality of life (Short Form-36 Health Survey). In study NCT00788034, 687 GAD subjects were treated open-label with vortioxetine 5 or 10 mg for 20 weeks, after which subjects in remission were randomized to fixed-dose of vortioxetine (5 or 10 mg) or placebo for at least 24 weeks. The primary endpoint was time to relapse. Analyses were completed in subjects working and/or pursuing an education at study entry and the full analysis set.
RESULTS: In study NCT00744627, the effect of vortioxetine versus placebo on HAM-A total score was -4.3 (p=0.0005) in working subjects (60% of total), while the effect in the total population was -3.8 (p=0.0001). The effect was greatest in subjects in professional (-4.5, p=0.0130) and associate professional positions (-7.6, p=0.0086). Greater effects in terms of response, remission, and the SDS and SF-36 were also observed. In NCT00788034, working subjects (69% of total) randomized to placebo were significantly more likely to relapse than subjects treated with vortioxetine (hazard ratio=2.9; p<0.001), while the hazard ratio in the total population was 2.7 (p<0.0001).
CONCLUSIONS: The beneficial effects of vortioxetine on anxiety symptoms, functioning, and quality of life are greater in adults with GAD who are working and/or pursuing an education versus the full GAD study population.
METHODS: In study NCT00744627, 301 GAD subjects were randomized to vortioxetine 5 mg or placebo for 8 weeks. Efficacy measures included the Hamilton Anxiety Rating Scale (HAM-A) total score, response/remission, global functioning (Sheehan Disability Scale [SDS]), and quality of life (Short Form-36 Health Survey). In study NCT00788034, 687 GAD subjects were treated open-label with vortioxetine 5 or 10 mg for 20 weeks, after which subjects in remission were randomized to fixed-dose of vortioxetine (5 or 10 mg) or placebo for at least 24 weeks. The primary endpoint was time to relapse. Analyses were completed in subjects working and/or pursuing an education at study entry and the full analysis set.
RESULTS: In study NCT00744627, the effect of vortioxetine versus placebo on HAM-A total score was -4.3 (p=0.0005) in working subjects (60% of total), while the effect in the total population was -3.8 (p=0.0001). The effect was greatest in subjects in professional (-4.5, p=0.0130) and associate professional positions (-7.6, p=0.0086). Greater effects in terms of response, remission, and the SDS and SF-36 were also observed. In NCT00788034, working subjects (69% of total) randomized to placebo were significantly more likely to relapse than subjects treated with vortioxetine (hazard ratio=2.9; p<0.001), while the hazard ratio in the total population was 2.7 (p<0.0001).
CONCLUSIONS: The beneficial effects of vortioxetine on anxiety symptoms, functioning, and quality of life are greater in adults with GAD who are working and/or pursuing an education versus the full GAD study population.