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Cerebrovascular accidents in patients treated for choroidal neovascularization with ranibizumab in randomized controlled trials

机译：雷珠单抗治疗脉络膜新生血管的患者的脑血管意外随机对照试验

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PURPOSE: To analyze cerebrovascular accidents (CVAs) pooled from large, randomized, controlled clinical trials of ranibizumab treatment for neovascular age-related macular degeneration. METHODS: Events in five trials (FOCUS, MARINA, ANCHOR, PIER, and SAILOR) were analyzed using a standard safety monitoring process. Exact methods, stratified by study, were used to test for treatment differences based on odds ratios. A stepwise logistic regression model was fit to classify subjects' risk for CVA based on medical history. Treatment differences in CVA rates at 1 year or 2 years were evaluated within risk groups using stratified exact methods. RESULTS: Pooled 2-year CVA rates were <3%; odds ratios (95% confidence intervals) for CVA risk were 1.2 (0.4-4.4) for ranibizumab 0.3-mg versus control, 2.2 (0.8-7.1) for 0.5 mg versus control, and 1.5 (0.8-3.0) for 0.5-mg versus 0.3-mg ranibizumab. No substantial increased risk of CVA for 0.5 mg versus 0.3 mg was identified in pooled analyses or any of the individual trials. In pooled analyses, the difference between 0.5-mg ranibizumab and control was larger (7.7 [1.2-177]) among high-risk CVA patients. CONCLUSION: This analysis provided some evidence, although not definitive, of a potential increased risk of CVA with ranibizumab versus control or with 0.5-mg versus 0.3-mg ranibizumab. Continued monitoring for CVA within clinical trials seems warrented.
机译：目的：分析从兰尼单抗治疗新血管性年龄相关性黄斑变性的大型，随机，对照临床试验中收集的脑血管意外（CVA）。方法：使用标准的安全监控流程分析了五项试验（FOCUS，MARINA，ANCHOR，PIER和SAILOR）中的事件。通过研究分层的确切方法，用于基于比值比测试治疗差异。逐步逻辑回归模型适用于根据病史对受试者的CVA风险进行分类。使用分层精确方法在风险组中评估1年或2年时CVA率的治疗差异。结果：2年合并CVA率<3％;雷珠单抗0.3 mg与对照组的CVA风险比值比（95％置信区间）为1.2（0.4-4.4），0.5 mg与对照组相比为2.2（0.8-7.1），0.5 mg与对照组相比为1.5（0.8-3.0） 0.3毫克兰尼单抗。在合并分析或任何单独的试验中，没有发现0.5 mg和0.3 mg CVA的显着增加风险。在汇总分析中，高风险CVA患者中0.5 mg雷珠单抗与对照之间的差异更大（7.7 [1.2-177]）。结论：该分析提供了一些证据，尽管不是确切的证据，但雷珠单抗相对于对照或0.5 mg比0.3 mg雷尼单抗可能增加CVA的风险。在临床试验中继续监测CVA似乎是令人担忧的。

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