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.

Keywords:

• China
• cognition
• functioning
• major depressive disorder
• real-world evidence
• vortioxetine

Data Sharing Statement

The authors confirm that the data supporting the findings of this study are available within the article. The authors may be contacted for further data sharing.

Ethics Approval and Informed Consent

The study was conducted in accordance with Good Clinical Practice guidelines, the principles of the Declaration of Helsinki, and local laws; as there was no central IRB available in China, the study was approved by the independent ethics committee of each participating study site. All participants provided written informed consent prior to enrollment.

Consent for Publication

This manuscript does not contain patient-sensitive material; therefore, no consent is needed.

Acknowledgments

The authors wish to thank all participants in the study, as well as the investigators and sites involved in conducting the trial including Yuping Ning, Tianmei Si, Yanqing Tang, Yonggui Yuan, Xiancang Ma, Hanping Bai, Daihui Peng, Lina Wang, Tao Li, Chunxue Wang, Lingjiang Li, Bin Zhang, and Yi Xu.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

GW has received honoraria for being an advisor to or providing educational talks for Lundbeck, Pfizer, Sumitomo, Johnson & Johnson, and Eli Lilly. JM is a full-time employee of Lundbeck China. EHR and LHH are full-time employees of H. Lundbeck A/S. HR and KS were employees of H. Lundbeck A/S at the time of the study. ZW, LB, XX, and PG report costs for conducting clinical study from Lundbeck, during the conduct of the study. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by H. Lundbeck A/S. Medical writing assistance was provided by Syneos Health Medical Communications LLC, and was supported by H. Lundbeck A/S.