PMH9 Effectiveness of Vortioxetine in Daily Practice in China. Interim Results from the Real-Life Effectiveness of Vortioxetine in China (RELIEVE CHINA) Study

Wang, G.; Ge, Haixia; Ma, Ji; Hammer-Helmich, Lene; Ren, Hongye

doi:10.1016/j.jval.2020.08.1087

Cited by 2 publications

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“…Therefore, any prescribed dosage of >10 mg to 20 mg of vortioxetine has been coded as a prescribed overdose in the context of this study, even though this dosing regimen was approved in many jurisdictions outside China. However, the interim results of this study 35 demonstrated safety of the higher dose, and the need for higher dosing to achieve adequate effectiveness in some patients, directly supporting the need for an expanded label for vortioxetine in China.…”

Section: Discussionmentioning

confidence: 61%

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

Wang¹,

Xiao²,

Ren³

et al. 2022

NDT

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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.

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Section: Discussionmentioning

confidence: 61%