Iskandrian Ami E, Bateman Timothy M, Belardinelli Luiz, Blackburn Brent, Cerqueira Manuel D, Hendel Robert C, Lieu Hsiao, Mahmarian John J, Olmsted Ann, Underwood S Richard, Vitola João, Wang Whedy
University of Alabama at Birmingham, Birmingham, AL 35294-0006, USA.
J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58. doi: 10.1016/j.nuclcard.2007.06.114.
Earlier phase 1 and 2 studies have shown that regadenoson has desirable features as a stress agent for myocardial perfusion imaging.
This multicenter, double-blinded phase 3 trial involved 784 patients at 54 sites. Each patient underwent 2 sets of gated single photon emission computed tomography myocardial perfusion imaging studies: an initial qualifying study with adenosine and a subsequent randomized study with either regadenoson (2/3 of patients) or adenosine. Regadenoson was administered as a rapid bolus (<10 seconds) of 400 mug. The primary endpoint was to demonstrate noninferiority by showing that the difference in the strength of agreement in detecting reversible defects, based on blinded reading, between sequential adenosine-regadenoson images and adenosine-adenosine images, lay above a prespecified noninferiority margin. Other prospectively defined safety and tolerability comparisons and supporting analyses were also performed. The average agreement rate based on the median of 3 independent blinded readers was 0.63 +/- 0.03 for regadenoson-adenosine and 0.64 +/- 0.04 for adenosine-adenosine-a 1% absolute difference with the lower limit of the 95% confidence interval lying above the prespecified noninferiority margin. Side-by-side interpretation of regadenoson and adenosine images provided comparable results for detecting reversible defects. The peak increase in heart rate was greater with regadenoson than adenosine, but the blood pressure nadir was similar. A summed symptom score of flushing, chest pain, and dyspnea was less with regadenoson than adenosine (P = .013).
This phase 3 trial shows that regadenoson provides diagnostic information comparable to a standard adenosine infusion. There were no serious drug-related side effects, and regadenoson was better tolerated than adenosine.
早期的1期和2期研究表明，雷加昔布作为心肌灌注成像的应激剂具有理想的特性。
这项多中心、双盲3期试验在54个地点纳入了784例患者。每位患者接受2组门控单光子发射计算机断层扫描心肌灌注成像研究：初始的腺苷资格研究以及随后使用雷加昔布（2/3的患者）或腺苷的随机研究。雷加昔布以400μg的快速推注（<10秒）给药。主要终点是通过显示基于盲法阅读，连续的腺苷-雷加昔布图像与腺苷-腺苷图像之间在检测可逆性缺损方面的一致性强度差异高于预先设定的非劣效性边界来证明非劣效性。还进行了其他预先定义的安全性和耐受性比较以及支持性分析。基于3名独立盲法阅读者中位数的平均一致性率，雷加昔布-腺苷为0.63±0.03，腺苷-腺苷为0.64±0.04，绝对差异为1%，95%置信区间下限高于预先设定的非劣效性边界。雷加昔布和腺苷图像的并排解读在检测可逆性缺损方面提供了可比的结果。雷加昔布使心率的峰值增加幅度大于腺苷，但血压最低点相似。雷加昔布引起的潮红、胸痛和呼吸困难的综合症状评分低于腺苷（P = 0.013）。
这项3期试验表明，雷加昔布提供的诊断信息与标准腺苷输注相当。没有严重的药物相关副作用，且雷加昔布的耐受性优于腺苷。
