Lam R W, Andersen H F
University of British Columbia, Vancouver, British Columbia, Canada.
Pharmacopsychiatry. 2006 Sep;39(5):180-4. doi: 10.1055/s-2006-949148.
To determine the differences between escitalopram and citalopram in the treatment of patients with major depressive disorder across a range of baseline severity of depression using trend analysis.
Data from the three placebo-controlled studies comparing escitalopram to citalopram were analyzed. The pre-specified primary outcome variable was MADRS total score; secondary outcomes included Clinical Global Impression-Severity (CGI-S) and -Improvement (CGI-I) scores. All analyses were based on an intent-to-treat (ITT) population and all direct comparisons were done by ANCOVA adjusting for baseline value and centre.
Analyses of the pooled data (N=1203) show that, while the difference between citalopram and placebo was approximately constant across the range of baseline severity, the difference between escitalopram and placebo (p=0.0010 for no trend) and between escitalopram and citalopram (p=0.0012 for no trend) became greater, the more severely depressed the patients were at baseline. A similar pattern was apparent with the CGI-S and CGI-I results. There was a significant superiority of escitalopram over citalopram in response rate (defined as > or = 50% decrease in MADRS total score), and this difference increased with increasing baseline severity.
These trend analyses thus indicate that the superiority of escitalopram over citalopram is more apparent as the baseline severity of depression increases.
采用趋势分析确定艾司西酞普兰和西酞普兰在治疗不同基线抑郁严重程度的重度抑郁症患者中的差异。
分析了三项比较艾司西酞普兰和西酞普兰的安慰剂对照研究的数据。预先设定的主要结局变量是蒙哥马利-艾森伯格抑郁量表(MADRS)总分;次要结局包括临床总体印象-严重程度(CGI-S)和-改善程度(CGI-I)评分。所有分析均基于意向性治疗(ITT)人群,所有直接比较均通过协方差分析(ANCOVA)进行,对基线值和中心进行了校正。
对汇总数据(N = 1203)的分析表明,虽然西酞普兰与安慰剂之间的差异在基线严重程度范围内大致保持不变,但艾司西酞普兰与安慰剂之间的差异(无趋势时p = 0.0010)以及艾司西酞普兰与西酞普兰之间的差异(无趋势时p = 0.0012)随着患者基线抑郁越严重而变得越大。CGI-S和CGI-I结果也呈现出类似的模式。艾司西酞普兰在缓解率(定义为MADRS总分降低≥50%)方面显著优于西酞普兰,且这种差异随着基线严重程度的增加而增大。
因此,这些趋势分析表明,随着抑郁基线严重程度的增加,艾司西酞普兰相对于西酞普兰的优势更加明显。