ترجمه مقاله بررسی اثربخشی ورتکسیتین در بیماران مبتلا به اختلال افسردگی شدید - نشریه الزویر

Background: Coexisting anxiety is common in major depressive disorder (MDD) and more difficult to treat than depression without anxiety. This analysis assessed the efficacy, safety, and tolerability of vortioxetine in MDD patients with high levels of anxiety (baseline Hamilton Anxiety Rating Scale [HAMA] total score Z20). Methods: Efficacy was assessed using an aggregated, study-level meta-analysis of 10 randomized, placebo-controlled, 6/8-week trials of vortioxetine 5–20 mg/day in adults (18–75 years), with a study in elderly patients (Z65 years) analyzed separately. Outcome measures included mean differences from placebo in change from baseline to endpoint (D) in the Montgomery-Åsberg Depression Rating Scale (MADRS), HAM-A total, and HAM-A subscales. Safety and tolerability were assessed by treatmentemergent adverse events (TEAEs). Results: A total of 1497 (48.6%) vortioxetine-treated and 860 (49.1%) placebo-treated patients had baseline HAM-AZ20. There were significant differences from placebo in MADRS (vortioxetine 5 mg/day, n¼415, D2.68, P¼0.005; 10 mg/day, n¼373, D3.59, Po0.001; 20 mg/day, n¼207, D4.30, P¼0.005) and HAM-A total (5 mg/day, n¼419, D1.64, P¼0.022; 10 mg/day, n¼373, D2.04, P¼0.003; 20 mg/ day, n¼207, D2.19, P¼0.027). There were significantly greater improvements versus placebo on the HAM-A psychic subscale for all doses. The most common TEAEs (Z5.0%) were nausea, headache, dizziness, dry mouth, diarrhea, nasopharyngitis, constipation, and vomiting. Incidence of serious TEAEs was 1.3% (placebo) and r1.3% (vortioxetine, across doses). Limitations: Study heterogeneity limits this analysis. Patients with baseline HAM-AZ20 were not directly compared to baseline HAM-Ao20 or total MDD population. Conclusions: Vortioxetine was efficacious in reducing depressive and anxiety symptoms in patients with MDD and high levels of anxiety. Crow