Effectiveness and Safety of Vortioxetine for Major Depressive Disorder in Real-World Clinical Practice: Results from the Single-Arm RELIEVE China Study

Abstract

Background Major depressive disorder (MDD) affects >163 million people worldwide and is a leading cause of disability in China. Functional impairment occurs alongside cognitive symptoms, anxiety, and depression, reducing quality of life and productivity in patients with MDD. Purpose The multimodal antidepressant vortioxetine has demonstrated efficacy in relieving depressive and functional symptoms of MDD in randomized controlled trials (RCTs). The RELIEVE China study aimed to investigate the real-world effectiveness of vortioxetine in China. Patients and Methods This was an observational, prospective cohort study in patients with MDD initiating treatment with vortioxetine at physician’s discretion in China. Participants were followed up for 24 weeks and assessed at 3 time points: baseline, week 8, and week 24. The primary objective was to assess the change from baseline to weeks 8 and 24 in functional impairment as measured by Sheehan Disability Scale (SDS) total score. Additional assessments included SDS subdomains, measures of depression severity, anxiety, and cognition. The safety and tolerability of vortioxetine were also examined. Results In total, 859 patients were included in the analysis. A consistent and significant improvement in functional impairment was observed during the study, with baseline mean SDS total score (16.7 points) decreasing by 5.42 (SE, 0.22) and 8.71 (SE, 0.226) points at week 8 and week 24, respectively ( P <0.0001). Improvements in other functioning, cognitive, and anxiety assessments were also observed (all P <0.0001). A total of 74.7% of patients had responded, and 63.9% had reached remission at week 24. The tolerability profile of vortioxetine in this real-world population was consistent with the established tolerability profile for this drug. Conclusion This study demonstrated the short- and long-term effectiveness and tolerability of vortioxetine for patients with MDD in a real-world setting in China. These findings are consistent with the efficacy and safety profile observed during RCTs.

Effectiveness of vortioxetine for major depressive disorder in real-world clinical practice: US cohort results from the global RELIEVE study

“…The improved functioning observed in this US cohort of patients with MDD treated with vortioxetine was consistent with previous observations in other real-world populations, with the 8.2-point reduction in SDS total score presented here as comparable to the 8.6- and 8.7-point reductions reported in the RELIEVE Global and RELIEVE China studies, respectively ( 22 , 26 ). This suggests that the efficacy of vortioxetine remained consistent in the US cohort compared with the RELIEVE global study population despite differences in patient characteristics.…”

Safety and effectiveness of vortioxetine for major depressive disorder: Real-world evidence from a population-based study in South Korea

“…Similarly, patients reported significant improvements in cognitive function via both DSST and PDQ-K. These results echoed the significant improvements in clinical symptoms and patient reported cognitive function reported in RCTs and/or real-world studies of vortioxetine (19,25,26,33,35,36).…”

“…Furthermore, another patient characteristic that has previously been suggested to be associated with poorer antidepressant treatment response and tolerability is female sex (39). This is particularly important as MDD can often be more prevalent in females than males (61.97% versus 38.03% at baseline in the current study and 65.9% versus 34.1% at baseline in the RELEIVE China study) (3,33). However, in this study, no significant differences were observed between males and females in either AEs or effectiveness estimates.…”

“…These differences may be attributable to differences between real-world and experimental clinical settings, such as more heterogeneous patient populations and less frequent follow-up visits in the real-world, leading to lower rates of AEs (34). Overall, the tolerability profile of vortioxetine was consistent with its known profile in the real-world setting (23,25,33).…”

“…The overall rate of AEs was 17.13%, with the most frequent types being nausea (5.12%), dizziness (1.32%) and headache (1.23%). The rate of overall AEs as well as that of frequent AEs was lower than observed in RCTs (overall AEs: 65.3%, nausea: 23.6%, dizziness: 5.6%, headache: 12.7%) (21), however, this is more comparable to rates observed in other real-world studies of vortioxetine in Western (RELIEVE: overall AEs of 21.2%, nausea of 8.2%, headache of 1.5% over 6 months) or Asian settings (TREVIDA: overall AEs of 6.7%, nausea of 1.2%, dizziness of 0.8% over 3 months; RELIEVE China: overall AEs of 42.1%, nausea of 18.3%, dizziness of 3.2%, headache of 1.3% over 6 months) (23,25,33). These differences may be attributable to differences between real-world and experimental clinical settings, such as more heterogeneous patient populations and less frequent follow-up visits in the real-world, leading to lower rates of AEs (34).…”