Hals-Nasen-Ohrenklinik, Technische Universität München, Munich 81675, Germany.
Expert Rev Clin Immunol. 2012 Nov;8(8):707-17. doi: 10.1586/eci.12.67.
Bradykinin is the key mediator of symptoms of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of edema of the skin, mucosa and muscle. Icatibant, a bradykinin B(2) receptor antagonist, is an effective and generally well-tolerated treatment option for acute attacks of type I and II HAE. A Phase III randomized, double-blind, placebo-controlled study, FAST-3 (NCT00912093), was designed to further evaluate the efficacy and safety of icatibant in patients presenting with moderate to very severe cutaneous and/or abdominal or mild-to-moderate laryngeal symptoms. Severe laryngeal attacks were treated with open-label icatibant. The controlled phase of FAST-3, completed in October 2010 with results published in December 2011, demonstrated that compared with placebo, icatibant evoked clinically meaningful and statistically significant efficacy across multiple end points in the treatment of type I and II HAE attacks. In addition, icatibant was generally well tolerated and no drug-related serious adverse events were experienced.
缓激肽是遗传性血管水肿（HAE）症状的关键介质，HAE 是一种罕见的遗传性疾病，其特征是皮肤、黏膜和肌肉反复出现水肿。艾替班特是一种缓激肽 B(2)受体拮抗剂，是治疗 I 型和 II 型 HAE 急性发作的有效且通常具有良好耐受性的治疗选择。一项 III 期随机、双盲、安慰剂对照研究 FAST-3（NCT00912093）旨在进一步评估艾替班特在中度至重度皮肤和/或腹部或轻度至中度喉部症状患者中的疗效和安全性。严重的喉部发作采用开放标签的艾替班特治疗。FAST-3 的对照阶段于 2010 年 10 月完成，结果于 2011 年 12 月公布，表明与安慰剂相比，艾替班特在治疗 I 型和 II 型 HAE 发作的多个终点上具有临床意义和统计学意义的疗效。此外，艾替班特通常具有良好的耐受性，没有发生与药物相关的严重不良事件。
