Baldwin David S, Reines Elin Heldbo, Guiton Christina, Weiller Emmanuelle
Clinical Neuroscience Division, University Department of Mental Health, Royal South Hants Hospital, Southampton, England.
Ann Pharmacother. 2007 Oct;41(10):1583-92. doi: 10.1345/aph.1K089. Epub 2007 Sep 11.
Randomized controlled clinical trials have demonstrated that escitalopram is efficacious in a range of mood and anxiety disorders, but the individual trials are insufficiently large to allow a full exploration of its tolerability.
To assess the tolerability and safety of escitalopram through analysis of all randomized controlled clinical trials in major depressive disorder and anxiety disorders.
Analyses of tolerability were based on data from all available randomized, double-blind, controlled studies completed by December 2006 in which escitalopram was compared with placebo or active compounds (citalopram, fluoxetine, paroxetine, sertraline, venlafaxine). Adverse events (AEs) that occurred more frequently with escitalopram than with placebo were listed, and tolerability and safety were evaluated.
Nausea was the only AE with an incidence greater than or equal to 10% and 5 percentage points greater than with placebo during short-term treatment. In general, AEs were mild to moderate in severity. AEs related to sexual dysfunction were similarly frequent with escitalopram and citalopram, but were higher with paroxetine. No suicide occurred among escitalopram-treated patients, and there were no significant differences between escitalopram and placebo in incidence of suicidal behavior, measured by self-harm and suicidal thoughts. The 8 week withdrawal rate due to AEs was higher with escitalopram than with placebo (7.3% vs 2.8%; p < 0.001) but lower than with paroxetine (6.6% vs 9.0%; p < 0.01) or venlafaxine (6.1% vs 13.2%; p < 0.01) (Fisher's Exact test, 2 tailed). Compared with paroxetine, escitalopram resulted in significantly fewer discontinuation symptoms (average increase in Discontinuation Emergent Signs and Symptoms Scale of 1.6 vs 3.9; p < 0.01). There were no clinically relevant changes in clinical laboratory values in patients treated with escitalopram. Mean weight change after 6 months of treatment with escitalopram (0.58 +/- 2.63 kg) was similar to that with placebo (0.15 +/- 2.33 kg). The incidence of cardiovascular events was similar to that with placebo. The risk of AEs was no higher in special patient populations, such as the elderly (> or =65 y of age) or those with hepatic dysfunction.
Based on data from randomized controlled trials involving more than 4000 escitalopram-treated patients, escitalopram (10-20 mg/day) is safe and well tolerated in short- and long-term treatment.
随机对照临床试验已证明艾司西酞普兰在一系列情绪和焦虑障碍中有效，但各个试验规模不足以全面探究其耐受性。
通过分析重度抑郁症和焦虑症的所有随机对照临床试验来评估艾司西酞普兰的耐受性和安全性。
耐受性分析基于2006年12月前完成的所有可用随机、双盲、对照研究的数据，其中将艾司西酞普兰与安慰剂或活性化合物（西酞普兰、氟西汀、帕罗西汀、舍曲林、文拉法辛）进行比较。列出了艾司西酞普兰组比安慰剂组更频繁出现的不良事件（AE），并评估了耐受性和安全性。
恶心是短期治疗期间唯一发生率大于或等于10%且比安慰剂组高5个百分点的AE。一般来说，AE的严重程度为轻度至中度。与性功能障碍相关的AE在艾司西酞普兰组和西酞普兰组中同样常见，但在帕罗西汀组中更高。接受艾司西酞普兰治疗的患者中未发生自杀事件，并且在以自残和自杀念头衡量的自杀行为发生率方面，艾司西酞普兰组与安慰剂组之间无显著差异。因AE导致的8周撤药率艾司西酞普兰组高于安慰剂组（7.3%对2.8%；p<0.001），但低于帕罗西汀组（6.6%对9.0%；p<0.01）或文拉法辛组（6.1%对13.2%；p<0.01）（Fisher精确检验，双侧）。与帕罗西汀相比，艾司西酞普兰导致的撤药症状明显更少（撤药后出现的体征和症状量表平均增加1.6对3.9；p<0.01）。接受艾司西酞普兰治疗的患者临床实验室值无临床相关变化。艾司西酞普兰治疗6个月后的平均体重变化（0.58±2.63kg）与安慰剂组（0.15±2.33kg）相似。心血管事件发生率与安慰剂组相似。特殊患者群体，如老年人（≥65岁）或肝功能不全者，AE风险并不更高。
基于涉及4000多名接受艾司西酞普兰治疗患者的随机对照试验数据，艾司西酞普兰（10 - 20mg/天）在短期和长期治疗中安全且耐受性良好。
