PDF(Pubmed)
Abstract：
UNASSIGNED: Data demonstrating the real-world, long-term effectiveness of vortioxetine in elderly patients with major depressive disorder (MDD) are clinically useful to confirm findings from randomized trials.
UNASSIGNED: RELIEVE was a multinational, 24-week, observational, prospective study in outpatients with MDD initiating vortioxetine treatment in routine care settings (NCT03555136). Here, we report data from a subgroup of 130 patients aged ⩾ 65 years. The primary study outcome was changed from baseline in patient functioning assessed using the Sheehan Disability Scale (SDS). Other clinical outcomes included depression severity (Patient Health Questionnaire-9 [PHQ-9] and Clinical Global Impressions-Severity [CGI-S]), cognitive performance (Digit Symbol Substitution Test [DSST]) and symptoms (Perceived Deficits Questionnaire - Depression-5 item [PDQ-D-5]), and health-related quality of life (HRQoL) (EuroQoL 5 Dimensions 5 Levels [EQ-5D-5L]).
UNASSIGNED: Clinically meaningful and statistically significant improvements in patient functioning, depressive symptoms, cognitive function, and HRQoL were observed at week 24. Least squares mean SDS, PHQ-9, CGI-S, PDQ-D-5, DSST, and EQ-5D-5L scores improved from baseline by 6.5, 5.7, 1.2, 3.2, 4.4, and 0.11 points, respectively (p < 0.01 for all). Adverse events were observed in 23.1% of patients.
UNASSIGNED: Consistent with previous clinical studies of vortioxetine, this study supports the effectiveness and safety of vortioxetine in treating elderly patients with MDD in a real-world setting over a 6-month period. Patients showed clinically relevant and sustained improvements in psychosocial functioning, depressive symptoms, and cognitive function after receiving vortioxetine, which was generally well tolerated. Main study limitations include the open-label study design and lack of a placebo or comparator group.
UNASSIGNED: RELIEVE was a multinational, 24-week, observational, prospective study in outpatients with MDD initiating vortioxetine treatment in routine care settings (NCT03555136). Here, we report data from a subgroup of 130 patients aged ⩾ 65 years. The primary study outcome was changed from baseline in patient functioning assessed using the Sheehan Disability Scale (SDS). Other clinical outcomes included depression severity (Patient Health Questionnaire-9 [PHQ-9] and Clinical Global Impressions-Severity [CGI-S]), cognitive performance (Digit Symbol Substitution Test [DSST]) and symptoms (Perceived Deficits Questionnaire - Depression-5 item [PDQ-D-5]), and health-related quality of life (HRQoL) (EuroQoL 5 Dimensions 5 Levels [EQ-5D-5L]).
UNASSIGNED: Clinically meaningful and statistically significant improvements in patient functioning, depressive symptoms, cognitive function, and HRQoL were observed at week 24. Least squares mean SDS, PHQ-9, CGI-S, PDQ-D-5, DSST, and EQ-5D-5L scores improved from baseline by 6.5, 5.7, 1.2, 3.2, 4.4, and 0.11 points, respectively (p < 0.01 for all). Adverse events were observed in 23.1% of patients.
UNASSIGNED: Consistent with previous clinical studies of vortioxetine, this study supports the effectiveness and safety of vortioxetine in treating elderly patients with MDD in a real-world setting over a 6-month period. Patients showed clinically relevant and sustained improvements in psychosocial functioning, depressive symptoms, and cognitive function after receiving vortioxetine, which was generally well tolerated. Main study limitations include the open-label study design and lack of a placebo or comparator group.
摘要：
■数据展示了现实世界，沃替西汀对患有重度抑郁障碍(MDD)的老年患者的长期有效性在临床上有助于证实随机试验的结果.
■RELIEVE是一家跨国公司，24周,观察,在常规护理环境中开始沃替西汀治疗的MDD门诊患者的前瞻性研究(NCT03555136)。这里,我们报告了130名65岁患者的亚组数据.使用Sheehan残疾量表（SDS）评估的患者功能的主要研究结果与基线相比有所变化。其他临床结果包括抑郁严重程度（患者健康问卷-9[PHQ-9]和临床整体印象-严重程度[CGI-S]），认知表现（数字符号替代测试[DSST]）和症状（感知缺陷问卷-抑郁-5项目[PDQ-D-5]），和健康相关生活质量（HRQoL）（EuroQoL5维度5水平[EQ-5D-5L]）。
■临床上有意义且具有统计学意义的患者功能改善，抑郁症状,认知功能,在第24周观察HRQoL。最小二乘均值SDS，PHQ-9,CGI-S,PDQ-D-5,DSST,EQ-5D-5L得分比基线提高了6.5、5.7、1.2、3.2、4.4和0.11分，分别(p<0.01)。在23.1%的患者中观察到不良事件。
■与以前的沃替西汀临床研究一致，本研究支持沃替西汀在6个月内治疗老年MDD患者的有效性和安全性.患者在心理社会功能方面表现出临床相关和持续的改善，抑郁症状,接受沃替西汀后的认知功能，一般耐受性良好。主要研究限制包括开放标签研究设计和缺乏安慰剂或比较组。
■RELIEVE是一家跨国公司，24周,观察,在常规护理环境中开始沃替西汀治疗的MDD门诊患者的前瞻性研究(NCT03555136)。这里,我们报告了130名65岁患者的亚组数据.使用Sheehan残疾量表（SDS）评估的患者功能的主要研究结果与基线相比有所变化。其他临床结果包括抑郁严重程度（患者健康问卷-9[PHQ-9]和临床整体印象-严重程度[CGI-S]），认知表现（数字符号替代测试[DSST]）和症状（感知缺陷问卷-抑郁-5项目[PDQ-D-5]），和健康相关生活质量（HRQoL）（EuroQoL5维度5水平[EQ-5D-5L]）。
■临床上有意义且具有统计学意义的患者功能改善，抑郁症状,认知功能,在第24周观察HRQoL。最小二乘均值SDS，PHQ-9,CGI-S,PDQ-D-5,DSST,EQ-5D-5L得分比基线提高了6.5、5.7、1.2、3.2、4.4和0.11分，分别(p<0.01)。在23.1%的患者中观察到不良事件。
■与以前的沃替西汀临床研究一致，本研究支持沃替西汀在6个月内治疗老年MDD患者的有效性和安全性.患者在心理社会功能方面表现出临床相关和持续的改善，抑郁症状,接受沃替西汀后的认知功能，一般耐受性良好。主要研究限制包括开放标签研究设计和缺乏安慰剂或比较组。
