Analysis Group, Inc., Boston, MA, United States.
Pharmacoepidemiol Drug Saf. 2012 May;21 Suppl 2:130-7. doi: 10.1002/pds.3246.
To illustrate a matching-adjusted indirect comparison by comparing the efficacy of guanfacine extended release (GXR) and atomoxetine (ATX) in reducing oppositional symptoms in children with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder.
Individual patient data were used from a GXR trial; only published summary data were used from ATX trials. In a matching-adjusted indirect comparison, individual patients from the GXR trial were weighted such that their mean baseline characteristics matched those published for ATX trials. Placebo-arm outcomes were then compared to further assess balance between the matched populations. Changes in the Conners' Parent Rating Scale-Revised Short Form Oppositional Subscale from baseline to endpoint among GXR-treated and ATX-treated patients were then compared.
Before matching, the GXR (n = 143) and ATX (n = 98) trial populations had significant differences in baseline characteristics and placebo-arm outcomes. After matching, baseline characteristics were well balanced across trials, and placebo-arm outcomes became nearly identical. Comparing active treatment arms across the matched populations, GXR was associated with a significantly greater reduction in mean Conners' Parent Rating Scale-Revised Short form oppositional subscale compared with ATX {-5.0 [95% confidence interval (CI): -6.6 to -3.4] vs. -2.4 [CI: -3.7 to -1.1], p = 0.01, effect size = 0.58}.
In the absence of head-to-head randomized trials, matching-adjusted indirect comparisons can provide timely and reliable comparative evidence for decision makers and can be applied even when very few trials are available for the treatments of interest.
通过比较胍法辛缓释剂(GXR)和托莫西汀(ATX)在减少伴有对立违抗障碍的注意缺陷多动障碍儿童的对立症状方面的疗效,来说明匹配调整间接比较。
使用 GXR 试验的个体患者数据;仅使用 ATX 试验的已发表汇总数据。在匹配调整间接比较中,GXR 试验中的个体患者被加权,以使他们的平均基线特征与 ATX 试验发表的数据相匹配。然后比较安慰剂组的结果,以进一步评估匹配人群之间的平衡。然后比较 GXR 治疗和 ATX 治疗患者从基线到终点时康纳斯父母评定量表修订短表对立分量表的变化。
在匹配之前,GXR(n=143)和 ATX(n=98)试验人群在基线特征和安慰剂组结果方面存在显著差异。匹配后,试验之间的基线特征得到很好的平衡,安慰剂组结果变得几乎相同。在匹配人群中比较活性治疗组,与 ATX 相比,GXR 与更显著的减少平均康纳斯父母评定量表修订短表对立分量表相关{-5.0 [95%置信区间(CI):-6.6 至-3.4] vs. -2.4 [CI:-3.7 至-1.1],p=0.01,效应大小=0.58}。
在没有头对头随机试验的情况下,匹配调整间接比较可以为决策者提供及时可靠的比较证据,即使对于感兴趣的治疗方法,只有很少的试验可用,也可以应用。