Evaluation Efficacy and Safety of Vortioxetine 20 mg/d versus Placebo for Treatment Major Depressive Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

• 作者: Abouzar Keshavarzi Ali Akbari Sari Hamidreza Dehghan Korush Saki Maryam Saran Masoud Behzadifar Meysam Behzadifar
• 来源期刊: 药理与制药(英文)
• 学科: 医学
• 关键词: MAJOR DEPRESSIVE DISORDER Vortioxetine 20 mg Systematic Review META-ANALYSIS
• 年，卷（期）: 2015,（4）
• 页码范围: 221-231
• 页数: 11页
• 分类号: R73

摘要

Major depressive disorder, a common debilitating illness, is one of the leading causes of disability and disease worldwide. Different drugs for the treatment of patients with major depression can be used. Vortioxetine for the treatment of major depressive disorder was approved by the Food and Drug Administration (FDA) in 2013. This study aimed to evaluation efficacy and safety Vortioxetine 20 mg/d compared placebo in major depressive disorder. To conduct this study, we searched Pub Med, Cochrane library, Scopus, and Central Register of Controlled Trials. This study by including randomized controlled trials (RCTs) that evaluated this study by including randomized controlled trials (RCTs) that evaluated Vortioxetine 20 mg/d in patients with major depressive disorder. Data analysis was conducted by standard mean different ratios (SMD) with 95% confidence intervals (CIs), P values and odds ratios (ORs) for adverse events with 95% confidence intervals (CIs) and P values;heterogeneity testing and sensitivity analysis was also performed in this study. We found that 4 articles met the inclusion criteria and were finally used for this meta-analysis. Results showed statistical significance in the MADRS (Montgomery-&Aringsberg Depression Rating Scale), SMD = -4.75 with 95% CI [-6.84, -2.65] and P value < 0.00001), for Clinical Global Impression Scale-Improvement (CGI-I) SMD was -4.34 with 95% CI [-6.41, -2.27] and P value < 0.00001, and for Sheehan Disability Scale (SDS) SMD was -2.62 with 95% CI [-3.99, -1.25] and P value < 0.00001. The pooled analysis for safety demonstrated for diarrhea OR = 0.92 with 95% CI [0.46, 1.83] , P value = 0.09, for dry mouth OR = 1.74 with 95% CI [1.07, 2.83] , P value = 0.80, for dizziness OR = 1.62 with 95% CI [0.72, 3.66] , P value = 0.05, for fatigue OR = 1.17 with 95% CI [0.34, 4.08], P value = 0.07, for headache OR = 1.28 with 95% CI [0.91, 1.79], P value = 0.60 and for nausea OR = 4.78 with 95% CI [3.43, 6.67], P value = 0.61. Vortioxetine 20 mg/d versus placebo showed a significant dif