New York Medical College, 11 Medical Park Drive, Suite 106, Pomona, Valhalla, NY 10970, USA.
Expert Opin Pharmacother. 2011 Dec;12(17):2751-8. doi: 10.1517/14656566.2011.632368. Epub 2011 Oct 28.
Olanzapine-fluoxetine combination is one of only two products currently approved by the US FDA for the acute treatment of depressive episodes associated with bipolar disorder.
This treatment evaluation reviews double-blind randomized controlled trials of olanzapine-fluoxetine combination for bipolar depression. A total of three primary study reports are found in the peer-reviewed literature. Additional data regarding the trials are obtained from study synopses disclosed on the internet by the manufacturer and from product labeling.
Number needed to treat for antidepressant response for olanzapine-fluoxetine combination versus placebo in the 8-week trials was 4 (95% CI 3 - 8), and that for remission was 5 (95% CI 3 - 8). Single-digit numbers needed to harm (NNH) values were observed for the treatment-emergent adverse events of weight gain (NNH 7, 95% CI 5 - 16) and diarrhea (NNH 9, 95% CI 5 - 30). NNH versus placebo for weight gain ≥ 7% from baseline was 6 (95% CI 4 - 10). When contrasted with lamotrigine, olanzapine-fluoxetine combination demonstrates statistically significantly greater improvement in depressive and manic symptoms but there is a higher incidence of treatment-emergent adverse events, weight gain and elevation in metabolic factors. Studies that directly compare quetiapine monotherapy with olanzapine-fluoxetine combination, the only two approved products for the treatment of bipolar depression, are not available. Nonetheless, indirect comparisons indicate similar efficacy outcomes but different tolerability profiles, with quetiapine principally being associated with sedation. Additional approved treatment options would be welcome.
奥氮平-氟西汀合剂是目前唯一两种获得美国 FDA 批准用于治疗双相情感障碍相关抑郁发作的产品之一。
本治疗评价综述了奥氮平-氟西汀合剂治疗双相抑郁的双盲随机对照试验。在同行评议文献中发现了总共 3 项主要研究报告。关于这些试验的其他数据来自制造商在互联网上披露的试验概要和产品标签。
在 8 周试验中，奥氮平-氟西汀合剂与安慰剂相比，抗抑郁反应的需要治疗数（NNT）为 4（95%CI 3-8），缓解的 NNT 为 5（95%CI 3-8）。治疗中出现的体重增加（NNH7，95%CI 5-16）和腹泻（NNH9，95%CI 5-30）等不良事件的需要治疗数（NNH）值为个位数。与安慰剂相比，体重增加≥7%的 NNH 为 6（95%CI 4-10）。与拉莫三嗪相比，奥氮平-氟西汀合剂在改善抑郁和躁狂症状方面显示出统计学上的显著优势，但治疗中出现的不良事件、体重增加和代谢因素升高的发生率更高。目前没有直接比较喹硫平单药治疗与奥氮平-氟西汀合剂的研究，后者是唯一两种获得批准用于治疗双相情感障碍的产品。尽管如此，间接比较表明两种药物具有相似的疗效，但耐受性特征不同，喹硫平主要与镇静作用有关。还需要更多的治疗选择。
