Horn J, de Haan R J, Vermeulen M, Limburg M
Department of Neurology, Academic Medical Center, University of Amsterdam (Netherlands).
Stroke. 2001 Feb;32(2):461-5. doi: 10.1161/01.str.32.2.461.
The Very Early Nimodipine Use in Stroke (VENUS) trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on survival and functional outcome after stroke. This was suggested in a previous meta-analysis on the use of nimodipine in stroke. However, in a recent Cochrane review we were unable to reproduce these positive results. This led to the early termination of VENUS after an interim analysis.
In this randomized, double-blind, placebo-controlled trial, treatment was started by general practitioners or neurologists within 6 hours after stroke onset (oral nimodipine 30 mg QID or identical placebo, for 10 days). Main analyses included comparisons of the primary end point (poor outcome, defined as death or dependency after 3 months) and secondary end points (neurological status and blood pressure 24 hours after inclusion, mortality after 10 days, and adverse events) between treatment groups. Subgroup analyses (on final diagnosis and based on the per-protocol data set) were performed.
At trial termination, after inclusion of 454 patients (225 nimodipine, 229 placebo), no effect of nimodipine was found. After 3 months of follow-up, 32% (n=71) of patients in the nimodipine group had a poor outcome compared with 27% (n=62) in the placebo group (relative risk, 1.2; 95% CI, 0.9 to 1.6). A treatment effect was not found for secondary outcomes and in the subgroup analyses.
The results of VENUS do not support the hypothesis of a beneficial effect of early nimodipine in stroke patients.
急性卒中早期使用尼莫地平（VENUS）试验旨在验证以下假设：卒中后早期使用尼莫地平对生存及功能转归具有积极作用。此前一项关于卒中时使用尼莫地平的荟萃分析提示了这一点。然而，在近期一项Cochrane综述中，我们未能重现这些阳性结果。这导致在中期分析后VENUS试验提前终止。
在这项随机、双盲、安慰剂对照试验中，由全科医生或神经科医生在卒中发作后6小时内开始治疗（口服尼莫地平30毫克，每日4次，或相同的安慰剂，持续10天）。主要分析包括比较治疗组之间的主要终点（不良转归，定义为3个月后死亡或依赖）和次要终点（纳入后24小时的神经状态和血压、10天后的死亡率以及不良事件）。进行了亚组分析（基于最终诊断并根据符合方案数据集）。
在试验终止时，纳入454例患者（225例使用尼莫地平，229例使用安慰剂）后，未发现尼莫地平有效果。随访3个月后，尼莫地平组32%（n = 71）的患者转归不良，而安慰剂组为27%（n = 62）（相对危险度，1.2；95%可信区间，0.9至1.6）。在次要结局及亚组分析中未发现治疗效果。
VENUS试验结果不支持早期尼莫地平对卒中患者有益的假设。
