Fu Alex Z, Christensen Dale B, Hansen Richard A, Liu Gordon G
Department of Quantitative Health Sciences, The Cleveland Clinic, Cleveland, Ohio 44195, and Division of Pharmaceutical Outcomes and Policy, University of North Carolina, Chapel Hill, USA.
Clin Ther. 2006 Jun;28(6):979-89. doi: 10.1016/j.clinthera.2006.06.011.
To date, few postmarketing studies have addressed whether long-term prophylactic treatment with second-generation antidepressants (ADs) delays depressive episodes in patients with bipolar disorder.
The aim of this study was to compare the risk of depressive relapse between patients with bipolar disorder who took second-generation ADs>-6 months after depressive remission with those who discontinued AD use early.
Using a large US managed-care claims database, continuously enrolled bipolar subjects who took second-generation ADs after a depressive remission were identified between January 1, 1998, and December 31, 2002. Duration of AD and concurrent mood stabilizer use were based on coded diagnoses and pharmacy records. A Cox proportional hazards model was developed to predict time from depressive remission to next depressive relapse with continuous AD use, categorized as either >or=6 months or <6 months. Propensity scoring with greedy matching was used to help balance the observed background covariates and baseline disease severity between groups.
Five hundred eighty-nine subjects met the inclusion criteria. A Kaplan-Meer estimate found that the median depressive relapse times for the continuous (ie, >or=6 months) and early discontinuation (ie, <6 months) AD treatment groups were 16.5 and 6.8 months, respectively (P<0.05). The Cox proportional hazards model with propensity score matching identified a significantly lower risk of depressive relapse over a 2-year period among those who continued AD treatment>or=6 months after remission, compared with those who discontinued treatment within 6 months (hazard ratio, 0.61 [95% CI, 0.42-0.88]; continuous vs early discontinuation, P<0.01).
Continuous second-generation AD therapy for >or=6 months after depressive remission was associated with a lower risk of depressive relapse over a 2-year period in patients with bipolar depression. Given concerns regarding the risk of AD users with bipolar disorder switching to mania, an optimal prophylactic treatment after depressive remission should balance the risks between manic switching and depressive relapse.
迄今为止，很少有上市后研究探讨第二代抗抑郁药（ADs）的长期预防性治疗是否能延缓双相情感障碍患者的抑郁发作。
本研究旨在比较抑郁缓解后服用第二代ADs超过6个月的双相情感障碍患者与早期停用ADs的患者之间抑郁复发的风险。
利用美国一个大型管理式医疗索赔数据库，确定1998年1月1日至2002年12月31日期间在抑郁缓解后持续服用第二代ADs的双相情感障碍患者。ADs和同时使用心境稳定剂的持续时间基于编码诊断和药房记录。建立Cox比例风险模型，以预测从抑郁缓解到下一次抑郁复发的时间，持续使用ADs分为≥6个月或<6个月。采用贪婪匹配的倾向评分法来平衡两组间观察到的背景协变量和基线疾病严重程度。
589名受试者符合纳入标准。Kaplan-Meier估计发现，持续（即≥6个月）和早期停药（即<6个月）AD治疗组的中位抑郁复发时间分别为16.5个月和6.8个月（P<0.05）。倾向评分匹配的Cox比例风险模型显示，与在6个月内停药的患者相比，缓解后持续服用ADs≥6个月的患者在2年内抑郁复发的风险显著降低（风险比，0.61[95%CI，0.42 - 0.88]；持续用药与早期停药，P<0.01）。
双相抑郁患者在抑郁缓解后持续使用第二代ADs≥6个月与2年内较低的抑郁复发风险相关。鉴于对双相情感障碍AD使用者转为躁狂风险的担忧，抑郁缓解后的最佳预防性治疗应平衡躁狂转换和抑郁复发之间的风险。
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