Wang Gang, Xiao Le, Ren Hongye, Simonsen Kenneth, Ma Jingdong, Xu Xiangdong, Guo Ping, Wang Zhiren, Bai Ludong, Heldbo Reines Elin, Hammer-Helmich Lene
The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital & the Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, People's Republic of China.
Medical Affairs, H. Lundbeck A/S, Valby, Denmark.
Neuropsychiatr Dis Treat. 2022 Aug 30;18:1939-1950. doi: 10.2147/NDT.S358253. eCollection 2022.
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.
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.
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.
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 (<0.0001). Improvements in other functioning, cognitive, and anxiety assessments were also observed (all <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.
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.
重度抑郁症（MDD）影响着全球超过1.63亿人，是中国致残的主要原因。功能损害与认知症状、焦虑和抑郁同时出现，降低了MDD患者的生活质量和生产力。
多模式抗抑郁药伏硫西汀在随机对照试验（RCT）中已证明对缓解MDD的抑郁和功能症状有效。中国缓解研究旨在调查伏硫西汀在中国的真实疗效。
这是一项在中国进行的观察性前瞻性队列研究，研究对象为经医生判断开始使用伏硫西汀治疗的MDD患者。参与者随访24周，并在3个时间点进行评估：基线、第8周和第24周。主要目的是评估以希恩残疾量表（SDS）总分衡量的从基线到第8周和第24周功能损害的变化。额外评估包括SDS子领域、抑郁严重程度、焦虑和认知的测量。还检查了伏硫西汀的安全性和耐受性。
总共859名患者纳入分析。研究期间观察到功能损害持续且显著改善，基线时SDS总分平均为（16.7分），在第8周和第24周分别下降了5.42（标准误，0.22）和8.71（标准误，0.226）分（<0.0001）。在其他功能、认知和焦虑评估方面也观察到改善（均<0.0001）。共有74.7%的患者有反应，63.9%的患者在第24周达到缓解。伏硫西汀在这一真实人群中的耐受性与该药物既定的耐受性一致。
本研究证明了伏硫西汀在中国真实环境中对MDD患者的短期和长期有效性及耐受性。这些发现与RCT期间观察到的疗效和安全性概况一致。
