自制鼻内注射依他阿米治疗症状性阵发性室上性心动过速播客：RAPID试验。

IF 3 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Cardiology and Therapy Pub Date : 2023-12-01 Epub Date: 2023-11-10 DOI:10.1007/s40119-023-00335-4

Bruce S Stambler, James E Ip

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引用次数: 0

摘要

阵发性室上性心动过速（PSVT）在临床实践中常见，对医疗系统和患者来说是一个重大负担。一线治疗包括钙通道阻滞剂（CCB），尽管它们是静脉注射的，需要医疗监督。依他阿米是一种用于无监督PSVT治疗的研究性自行给药的L型鼻内CCB。在本播客中，我们讨论了RAPID试验（NCT03464019），这是一项3期研究，评估了异搏定使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）记录的持续PSVT发作的成年人 ≥ 20分钟。耐受试验剂量异搏定的患者被1:1随机分配接受异搏定或安慰剂。在发现PSVT症状后，患者开始心电图监测并进行迷走神经活动。如果心律失常终止不成功，他们自行给药70 mg异搏定或安慰剂，10分钟后任选第二次给药。主要终点是PSVT在初始剂量后30分钟内转变为窦性心律的时间，并持续 ≥ 30秒。安全组包括所有自行接受研究治疗的患者。在692名入选者中，184人自行服用研究药物（99 etripamil，85安慰剂）治疗心电图证实的PSVT。在接受异搏定治疗的受试者中，64.3%的人在30分钟内将PSVT转换为窦性心律，而接受安慰剂治疗的受受试者为31.2%。与安慰剂组的53.5分钟相比，异搏定组的中位转化时间显著缩短了三倍，为17.2分钟。治疗后出现的不良事件为轻度或中度，主要包括短暂的鼻腔不适、鼻塞和鼻漏。如果etripamil获得美国食品药品监督管理局的批准，它可能会解决临床环境之外对PSVT治疗的重大未满足需求，从而减少需要医疗监督的静脉注射治疗的需求。播客可用于本文。

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

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.

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来源期刊

Cardiology and Therapy CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

5.30

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Cardiology and Therapy is an international, open access, peer reviewed (single-blind), rapid-publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of cardiovascular therapies and interventions, including devices. Studies relating to diagnosis and diagnostics, pharmacoeconomics, public health, quality of life, as well as patient care, management and education are also encouraged. Areas of focus include, but are not limited to, ischaemic heart disease and acute cardiac care, myocardial, valvular, pericardial and congenital heart disease, vascular and pulmonary disease (including hypertension), arrhythmias, heart failure, non-invasive diagnostic techniques, and invasive and interventional cardiology as well as cardiovascular surgery. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols and short communications such as commentaries and editorials. Cardiolology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of cardiovascular therapies. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. 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Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. 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