阿齐尔沙坦作为日本6岁以下儿童的抗高血压治疗:一项第3期开放式长期研究
Shuichi Ito1, Masakazu Miyamoto2, Yuki Mizuta2
1Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan.
概括
阿齐尔沙坦在52周的时间内表现出良好的耐受性和持续的血压降低,在患有高血压的2至6岁的日本儿童中. 没有发现新的安全问题,这表明它有可能成为一种治疗选择.
科学领域:
- 儿科脏病学 儿科脏病学
- 心血管药理学心血管药理学
- 临床药物试验 临床药物试验
背景情况:
- 儿科高血压管理具有挑战性.
- 以前的研究证实了阿齐尔沙坦在6至15岁儿童的安全性.
- 在6岁以下的儿童中,疗效和安全性尚未评估.
研究的目的:
- 评估阿齐尔沙坦在2至6岁的日本儿童高血压患者中的安全性和有效性.
- 评估治疗出现的不良事件 (TEAE) 和其他安全参数.
- 为了确定药物在52周内对血压的影响.
主要方法:
- 第三阶段,开放标签研究设计.
- 九名日本儿科患者 (2至6岁以下) 患有高血压,每天接受阿齐尔沙坦.
- 剂量范围从0.1毫克/千克,如果没有达到目标血压,则定位至0.8毫克/千克.
- 治疗持续时间为52周.
主要成果:
- 所有患者都经历了轻度至中度的TEAE;33.3%有与药物相关的TEAE (急性损伤,贫血,功能障碍).
- 急性损伤是唯一严重的与药物相关的TEAE,在治疗中断时得到解决.
- 在第12周和第52周观察到持续下降的静缩和静缩血压.
- 由于TEAE,没有死亡或研究中断.
结论:
- 亚齐尔沙坦在2岁至6岁以下的日本儿科患者中一般耐受良好.
- 这种药物与52周的持续血压降低有关.
- 阿齐尔沙坦代表了小儿高血压的潜在治疗选择,可能改善长期心血管结果.
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