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关于自我给药鼻内艾托咪尔治疗症状性阵发性室上性心动过速的播客:RAPID试验

Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial.

作者信息

Stambler Bruce S, Ip James E

机构信息

Piedmont Heart Institute, Atlanta, GA, USA.

Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY, USA.

出版信息

Cardiol Ther. 2023 Dec;12(4):545-555. doi: 10.1007/s40119-023-00335-4. Epub 2023 Nov 10.

Abstract

Paroxysmal supraventricular tachycardia (PSVT) is commonly seen in clinical practice and represents a significant burden to the healthcare system and to patients. First-line treatments include calcium channel blockers (CCB), although they are intravenous and require medical supervision. Etripamil is an investigational self-administered intranasal L-type CCB for unsupervised treatment of PSVT. In this podcast, we discuss the RAPID trial (NCT03464019), which was a phase 3 study that evaluated the safety and efficacy of etripamil in terminating PSVT episodes using a repeat-dosing regimen. RAPID was a multicenter, randomized trial that enrolled adults with electrocardiograph (ECG)-documented PSVT episodes lasting ≥ 20 min. Patients who tolerated test doses of etripamil were randomized 1:1 to receive either etripamil or placebo. Upon perceiving PSVT symptoms, patients began ECG monitoring and performed a vagal maneuver. If arrhythmia termination was unsuccessful, they self-administered 70 mg of etripamil or placebo, followed by an optional second dose after 10 min. The primary endpoint was time to conversion of PSVT to sinus rhythm within 30 min of the initial dose and sustained for ≥ 30 s. The safety group included all patients who self-administered the study treatment. Of 692 enrollees, 184 self-administered the study drug (99 etripamil, 85 placebo) for ECG-confirmed PSVT. Conversion of PSVT to sinus rhythm within 30 min was achieved in 64.3% of etripamil-treated subjects versus 31.2% of placebo-treated subjects. A significant threefold reduction in the median time to conversion of 17.2 min was observed in the etripamil group versus 53.5 min in the placebo group. Treatment-emergent adverse events were mild or moderate and primarily included transient nasal discomfort, nasal congestion, and rhinorrhea. If etripamil is approved by the US FDA, it can potentially address a significant unmet need for PSVT treatment outside a clinical setting, reducing the need for intravenous treatments that require medical supervision.Podcast available for this article.

摘要

阵发性室上性心动过速(PSVT)在临床实践中较为常见,给医疗系统和患者带来了沉重负担。一线治疗方法包括钙通道阻滞剂(CCB),不过它们是静脉注射用药,需要医疗监护。依曲帕米是一种正在研究的可自行给药的鼻内用L型CCB,用于无监护情况下治疗PSVT。在本播客中,我们讨论了RAPID试验(NCT03464019),这是一项3期研究,评估了依曲帕米采用重复给药方案终止PSVT发作的安全性和有效性。RAPID是一项多中心随机试验,纳入了心电图(ECG)记录的PSVT发作持续时间≥20分钟的成年人。耐受依曲帕米试验剂量的患者按1:1随机分组,接受依曲帕米或安慰剂治疗。一旦察觉到PSVT症状,患者便开始进行ECG监测并实施迷走神经手法。如果心律失常终止未成功,他们自行服用70毫克依曲帕米或安慰剂,10分钟后可选择再服一剂。主要终点是初始剂量后30分钟内PSVT转为窦性心律的时间,且持续≥30秒。安全组包括所有自行服用研究药物的患者。在692名受试者中,184人自行服用了研究药物(99人服用依曲帕米,85人服用安慰剂)用于ECG确诊的PSVT。依曲帕米治疗组64.3%的受试者在30分钟内实现了PSVT转为窦性心律,而安慰剂治疗组这一比例为31.2%。依曲帕米组与安慰剂组相比,转为窦性心律的中位时间显著缩短了三倍,分别为17.2分钟和53.5分钟。治疗中出现的不良事件为轻度或中度,主要包括短暂的鼻部不适、鼻塞和流涕。如果依曲帕米获得美国食品药品监督管理局(FDA)批准,它有可能满足临床环境之外PSVT治疗的一项重大未满足需求,减少对需要医疗监护的静脉治疗的需求。本文配有播客。

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