Great Ormond Street Hospital, University College London, London, UK.
Eur Heart J. 2010 Nov;31(21):2650-9. doi: 10.1093/eurheartj/ehq133. Epub 2010 May 21.
The DoUble-blind Atorvastatin AmLodipine (DUAAL) trial investigated whether atorvastatin decreases ischaemia by a vascular benefit, independent of low-density lipoprotein cholesterol lowering, in patients with coronary artery disease (CAD), both alone and in combination with the traditional anti-anginal therapy, amlodipine.
Randomized, double-blind, parallel-group, multicountry trial (2 weeks run-in and 24 weeks active therapy) comparing three treatments: amlodipine, atorvastatin, and amlodipine + atorvastatin; in 311 patients (78% male; mean age 62 years) with stable angina (≥ 2 attacks/week), CAD history, ≥ 3 transient myocardial ischaemia (TMI) episodes, and/or ≥ 15 min ischaemia on 48 h ambulatory electrocardiographic (AECG) monitoring. Efficacy variables were change in TMI by AECG, exercise ischaemia, angina diary data, and inflammatory biomarkers at Week 26. There was a comparable, highly significant decrease in TMI with amlodipine and atorvastatin, but no additional benefit for the combination. More than 50% of patients became TMI-free in all three groups and this was accompanied by a comparable, marked reduction in angina and nitroglycerin consumption. High-sensitivity C-reactive protein fell by 40% in patients receiving atorvastatin but there was no change with amlodipine. Adverse events were comparable among groups.
Atorvastatin was as potent an anti-ischaemic agent as amlodipine. Future studies of combination therapies will be instructive.
National clinical trial number: NCT00159718, protocol number A0531031 listed on http://clinicaltrials.gov/.
双联阿托伐他汀氨氯地平（DUAAL）试验旨在研究阿托伐他汀是否通过血管获益降低缺血，而不依赖于降低低密度脂蛋白胆固醇，在患有冠心病（CAD）的患者中，无论是单独使用还是与传统抗心绞痛治疗氨氯地平联合使用。
这是一项随机、双盲、平行分组、多国试验（2 周导入期和 24 周活性治疗期），比较了三种治疗方法：氨氯地平、阿托伐他汀和氨氯地平+阿托伐他汀；共纳入 311 例（78%为男性；平均年龄 62 岁）稳定性心绞痛（每周≥2 次发作）、CAD 病史、≥3 次短暂性心肌缺血（TMI）发作和/或 48 小时动态心电图（AECG）监测时≥15 分钟的缺血患者。疗效变量是通过 AECG 检测的 TMI 变化、运动缺血、心绞痛日记数据和炎症生物标志物在第 26 周的变化。氨氯地平和阿托伐他汀均可显著降低 TMI，且疗效相当，但联合治疗无额外获益。三组中超过 50%的患者 TMI 消失，且同时伴有心绞痛和硝化甘油消耗量的显著减少。阿托伐他汀治疗组的高敏 C 反应蛋白下降 40%，而氨氯地平组无变化。各组不良反应相当。
阿托伐他汀与氨氯地平一样有效，是一种有效的抗缺血药物。未来的联合治疗研究将具有指导意义。
国家临床试验编号：NCT00159718，方案编号 A0531031，可在 http://clinicaltrials.gov/ 上查询。
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