Mattingly Gregory W, Ren Hongye, Christensen Michael Cronquist, Katzman Martin A, Polosan Mircea, Simonsen Kenneth, Hammer-Helmich Lene
St Charles Psychiatric Associates & Midwest Research Group, St Charles, MO, United States.
Medical Affairs, H. Lundbeck A/S, Valby, Denmark.
Front Psychiatry. 2022 Mar 9;13:824831. doi: 10.3389/fpsyt.2022.824831. eCollection 2022.
Randomized controlled clinical trials have shown vortioxetine to be efficacious and well tolerated for the treatment of major depressive disorder (MDD). The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study was undertaken to demonstrate the effectiveness and safety of vortioxetine for the treatment of MDD in routine clinical practice.
RELIEVE was a 24-week, observational, prospective cohort study in outpatients with MDD initiating treatment with vortioxetine at their physician's discretion in routine care settings in Canada, France, Italy, and the USA (NCT03555136). The primary study outcome was patient functioning assessed by the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity [9-item Patient Health Questionnaire (PHQ-9)], cognitive symptoms [5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5)], and cognitive performance [Digit Symbol Substitution Test (DSST)]. Mixed models of repeated measures were used to assess change from baseline at week 24, adjusted for relevant confounders.
A total of 737 patients were eligible for inclusion in the full analysis set. Most patients (73.7%) reported at least one comorbid medical condition, 56.0% had comorbid anxiety and 24.4% had comorbid generalized anxiety disorder. Improvement in least-squares (LS) mean SDS score from baseline to week 24 was 8.7 points. LS mean PHQ-9, PDQ-D-5 and DSST scores improved by 7.4, 4.6, and 6.2 points, respectively. Adverse events were observed in 21.2% of patients [most commonly, nausea (8.2% of patients)].
These results demonstrate the effectiveness and tolerability of vortioxetine for the treatment of MDD in a large and heterogeneous patient population representative of that encountered in routine clinical practice.
随机对照临床试验表明，伏硫西汀对治疗重度抑郁症（MDD）有效且耐受性良好。开展伏硫西汀治疗抑郁症的真实生活有效性（RELIEVE）研究，以证明伏硫西汀在常规临床实践中治疗MDD的有效性和安全性。
RELIEVE是一项为期24周的观察性前瞻性队列研究，研究对象为加拿大、法国、意大利和美国常规护理机构中由医生酌情决定开始使用伏硫西汀治疗的MDD门诊患者（NCT03555136）。主要研究结局是通过希恩残疾量表（SDS）评估的患者功能。次要结局包括抑郁严重程度[9项患者健康问卷（PHQ-9）]、认知症状[5项感知缺陷问卷-抑郁（PDQ-D-5）]和认知表现[数字符号替换测验（DSST）]。采用重复测量混合模型评估第24周时相对于基线的变化，并对相关混杂因素进行校正。
共有737例患者符合纳入全分析集的条件。大多数患者（73.7%）报告至少有一种合并内科疾病，56.0%合并焦虑症，24.4%合并广泛性焦虑症。从基线到第24周，最小二乘（LS）平均SDS评分改善了8.7分。LS平均PHQ-9、PDQ-D-5和DSST评分分别改善了7.4分、4.6分和6.2分。21.2%的患者观察到不良事件[最常见的是恶心（占患者的8.2%）]。
这些结果证明了伏硫西汀在代表常规临床实践中所遇到的大量异质性患者群体中治疗MDD的有效性和耐受性。
