CHU de Montpellier, Université Montpellier 1, France.
Curr Med Res Opin. 2010 Mar;26(3):605-14. doi: 10.1185/03007990903482467.
To investigate if treatment outcome for severely depressed patients depends on their baseline level of anxiety.
Patients with a primary diagnosis of severe major depressive disorder (n = 459) were randomised to 24 weeks of double-blind treatment with escitalopram (20 mg) or paroxetine (40 mg). Post hoc analyses of efficacy in patients with a baseline HAM-A total score < or =20 (n = 171) or >20 (n = 280) were based on analysis of covariance (ANCOVA) (ITT, LOCF).
At week 24, the mean change from baseline in MADRS total scores was -24.2 for escitalopram-treated patients (n = 141) and -21.5 for paroxetine-treated patients (n = 139) (p < 0.05) in high baseline anxiety patients and the mean change from baseline in HAM-A total score was -17.4 (escitalopram) and -15.1 (paroxetine) (p < 0.05). When examining the proportion of complete remitters (CGI-S = 1) after 24 weeks of treatment, there was an increasing treatment difference as a function of baseline HAM-A total score in favour of escitalopram (ITT, LOCF). There was no treatment difference in the low baseline anxiety group. Significantly more patients (p < 0.01) withdrew from the paroxetine group (31%) than from the escitalopram group (17%), partly as the result of significantly more withdrawals due to AEs (p < 0.05). Incidence of AEs and withdrawals were not related to baseline anxiety and there were no significant differences in the incidence of individual AEs with escitalopram compared to paroxetine.
The post hoc nature of these analyses, the absence of placebo control group, and the requirement that patients should be suffering from severe depression, limit the generalisability of the results.
Patients with severe depression together with comorbid anxiety symptoms responded significantly better to treatment with escitalopram 20 mg compared with paroxetine 40 mg. Contrary to paroxetine, escitalopram maintained its efficacy with increasing baseline anxiety levels.
探讨严重抑郁患者的治疗结果是否取决于其基线焦虑水平。
将 459 例原发性严重抑郁症患者随机分为 24 周的艾司西酞普兰(20mg)或帕罗西汀(40mg)双盲治疗。根据协方差分析(ITT,LOCF)对基线 HAM-A 总分<或=20 分(n=171)或>20 分(n=280)患者的疗效进行事后分析。
第 24 周时,艾司西酞普兰治疗组(n=141)和帕罗西汀治疗组(n=139)的 MADRS 总分自基线的平均变化分别为-24.2 和-21.5(p<0.05),高基线焦虑患者的 HAM-A 总分自基线的平均变化分别为-17.4(艾司西酞普兰)和-15.1(帕罗西汀)(p<0.05)。当检查 24 周治疗后的完全缓解者比例(CGI-S=1)时,艾司西酞普兰的治疗效果随基线 HAM-A 总分的增加而增加(ITT,LOCF)。在低基线焦虑组中,治疗效果没有差异。帕罗西汀组(31%)的患者退出率明显高于艾司西酞普兰组(17%)(p<0.01),部分原因是由于 AEs 导致的退出人数明显增多(p<0.05)。AE 和退出的发生率与基线焦虑无关,艾司西酞普兰与帕罗西汀相比,AE 的发生率没有显著差异。
这些分析的事后性质、缺乏安慰剂对照组以及要求患者患有严重抑郁症,限制了结果的普遍性。
患有严重抑郁症并伴有共病焦虑症状的患者对艾司西酞普兰 20mg 的治疗反应明显优于帕罗西汀 40mg。与帕罗西汀相反,艾司西酞普兰的疗效随着基线焦虑水平的升高而保持。