The effect of vortioxetine on health-related quality of life in patients with major depressive disorder.
OBJECTIVE
Major depressive disorder (MDD) has detrimental effects on health-related quality of life (HRQoL). We describe the effect of vortioxetine on HRQoL in MDD patients by using patient-reported outcome instruments.


METHODS
HRQoL was evaluated in 5 short-term (6-8 weeks), randomized studies of vortioxetine (5-20 mg/d; n = 2155) versus placebo (n = 1316) in adults with MDD by using the 36-item Short-Form Health Survey (SF-36), the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, the EuroQol 5-Dimension Questionnaire (EQ-5D), and the 12-item Health Status Questionnaire in 1 study in elderly patients. Only patients receiving the approved doses of vortioxetine 5, 10, 15, or 20 mg/d were included in the analysis. A random effects meta-analysis was performed on the 4 adult MDD studies that used the SF-36. A within-studies mixed model for repeated measures analysis based on the full analysis set (FAS) was used unless otherwise specified. Standardized effect size (SES) was calculated to reflect clinical relevance, based on a Cohen's d of 0.2.


RESULTS
Vortioxetine produced significantly better results compared with placebo in the SF-36 mental component summary score (5 mg: 2.6, P = 0.001, SES of 0.22, n = 604; 10 mg: 4.8, P < 0.001, SES of 0.42, n = 328) and 4 domain scores (vitality, social functioning, role emotional, and mental health). Vortioxetine was also significantly better in the EuroQoL-5 Dimension Questionnaire Health State score (10 mg: 7.5, P < 0.05, SES of 0.33, n = 86) and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form total score (15 mg: 3.3, P < 0.01, SES of 0.38, n = 127; 20 mg: 4.5, P < 0.0001, SES of 0.52, n = 134) (FAS, last-observation-carried-forward). In the study of elderly patients, vortioxetine 5 mg (n = 136) improved 12-item Health Status Questionnaire scores significantly more than placebo (n = 148) for the domains of health perception (10.4, P < 0.0001, SES of 0.54), mental health (7.9, P < 0.001, SES of 0.44), and energy (6.4, P < 0.05, SES of 0.28) (FAS, mixed model for repeated measures).


CONCLUSIONS
Vortioxetine yielded significant, meaningful HRQoL improvements in 6 MDD studies of 6 to 8 weeks' duration.
H. Lundbeck A/S, Valby, Denmark.
Ioana
I
Florea
Lundbeck SAS, Paris, France. Electronic address: NADO@lundbeck.com.
Natalya
N
Danchenko
Lundbeck SAS, Paris, France.
Melanie
M
Brignone
H. Lundbeck A/S, Valby, Denmark.
Henrik
H
Loft
Lundbeck SAS, Paris, France.
Benoit
B
Rive
Patient-Centered Outcomes Assessments Ltd, United Kingdom.
Linda
L
Abetz-Webb
D000328:Adult; D000368:Aged; D003865:Major Depressive Disorder / Q000188:drug therapy*; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013440:Sulfides / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D000078784:Vortioxetine
D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D013440:Sulfides; D000078784:Vortioxetine
antidepressant; health-related quality of life; major depressive disorder; patient-reported outcomes; vortioxetine