Post-operative atrial fibrillation is a common problem post cardiac surgery with rates exceeding 30%. Atrial fibrillation has multiple adverse effects on cardiac hemodynamics and can lead to hypotension, diminished end organ perfusion and lengthen the stay in ICU. Amiodarone is the medication of choice used for pharmacological cardioversion and can be used with vasoactive medications. Intravenous amiodarone is associated with hypotension and end organ perfusion requiring escalation in vasoactive support. Vernakalant is novel anti-arrhythmic agent approved in Canada for cardioversion of atrial fibrillation that primarily works on atrial channels and has no effect on contractility or vasodilation. Clinical trials have proved good efficacy of Vernakalant in conversion of paroxysmal atrial fibrillation however there is no comparison of Amiodarone to Vernakalant in post-operative cardiac surgery. We plan to perform a clinical trial comparing Vernakalant to amiodarone in post-cardiac surgery patients with a primary outcome of cardioversion at 90 minutes. Secondary outcomes will follow duration of vasoactive medications, days in ICU and economics.

开始日期2024-09-01

申办/合作机构

University of Calgary

NCT04485195

/ Completed临床4期IIT

RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department

The objective is to compare IV vernakalant to IV procainamide for the ED management of acute AF patients. If vernakalant proves to be more effective, faster, and safer than IV procainamide, this will give clinicians an important alternative for pharmacological cardioversion of acute AF. The investigators propose a pragmatic comparative effectiveness trial entailing an open label, randomized controlled trial at 12 large Canadian EDs. Study subjects will be randomized to 1 of 2 treatment arms: 1) Patients will receive an initial infusion of 3mg/kg of IV vernakalant over 10 minutes, followed by a second dose of 2mg/kg over 10 minutes, if necessary, or 2) Patients will receive a continuous infusion of 15mg/kg of IV procainamide over 60 minutes. The primary aim will be to compare conversion to normal sinus rhythm between the two drugs. The investigators will include stable patients presenting with an episode of acute AF of at least 3 hours duration, where symptoms require urgent management and where immediate cardioversion is a reasonable option. Using the integrated consent model, research assistants will obtain verbal consent from eligible patients.

开始日期2021-06-17

申办/合作机构

Ottawa Hospital Research Institute

NCT03005366

/ Completed临床4期IIT

Randomized Clinical Trial to Study Pharmacological Cardioversion of Paroxysmal Atrial Fibrillation by Vernakalant and Flecainide

* The main objective of this project is to study the efficacy and the mechanistic value of blocking both atrial specific and atria-preferential dynamics of ionic currents to terminate paroxysmal atrial fibrillation (AF).
* The hypothesis is that a drug blocking atrial specific and atria-preferential dynamics of ionic currents (IK,ACh - acetylcholine sensitive K+ current - and INa - inward sodium current - , respectively) will be more effective to terminate paroxysmal AF episodes with fast atrial activation rates, than a classical INa blocker, which will be more effective to terminate AF episodes with slower activation rates.
* The investigators will include patients without structural heart disease and short-lasting AF episodes (<48 h.). Double blind and single center study, in which patients will be randomly assigned to a cardioversion group using intravenous flecainide or to an atria-preferential and atrial-specific blockade group using intravenous vernakalant. Patients will be routinely monitored in the electrophysiology room to acquire both 12-lead digitized ECG signals and non-invasive body surface potential mapping. Atrial signals will be extracted from both the multisite body surface and ECG recordings to obtain temporal and spectral parameters, and measure organization and atrial rate in both groups. The results obtained in the clinical setting will be studied in mathematical models to understand their capability to terminate paroxysmal AF. The project expects to provide consistent, reliable and reproducible parameters that will assist clinicians to know what type of paroxysmal AF episodes will be more suitable to effectively terminate, upon administration of drugs with an atrial specific and atria-preferential profile.

开始日期2017-01-01

申办/合作机构

Hospital San Carlos, Madrid

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项与盐酸维那卡兰相关的文献（医药）

2025-08-01·Cardiovascular drugs and therapy

Safety and Effectiveness of Antidysrhythmic Drugs for Pharmacologic Cardioversion of Recent-Onset Atrial Fibrillation: a Systematic Review and Bayesian Network Meta-analysis

Review

作者: Thode, Henry ; Shrestha, Pragati ; deSouza, Ian S ; Allen, Robert ; Koos, Jessica

PURPOSE:

The available evidence to determine which antidysrhythmic drug is superior for pharmacologic cardioversion of recent-onset (onset within 48 h) atrial fibrillation (AF) is uncertain. We aimed to identify the safest and most effective agent for pharmacologic cardioversion of recent-onset AF in the emergency department.

METHODS:

We searched MEDLINE, Embase, and Web of Science from inception to February 21, 2023 (PROSPERO: CRD42018083781). Eligible studies were randomized controlled trials that enrolled adult participants with AF ≤ 48 h, compared a guideline-recommended antidysrhythmic drug with another antidysrhythmic drug or a different formulation of the same drug or placebo and reported specific adverse events. The primary outcome was immediate, serious adverse event - cardiac arrest, sustained ventricular tachydysrhythmia, atrial flutter 1:1 atrioventricular conduction, hypotension, and bradycardia. Additional analyses included the outcomes of conversion to sinus rhythm within 4 h and 24 h. We extracted data according to PRISMA-NMA and appraised trials using Cochrane RoB 2. We performed Bayesian network meta-analysis (NMA) using a Markov Chain Monte Carlo method with random-effect model and vague prior distribution to calculate odds ratios with 95% credible intervals. We assessed confidence using CINeMA. We used surface under the cumulative ranking curve (SUCRA) to rank agent(s).

RESULTS:

The systematic review initially identified 5545 studies. Twenty-five studies met eligibility criteria, and 22 studies (n = 3082) provided data for NMA, which demonstrated that vernakalant (SUCRA = 70.9%) is most likely to be safest. Additional effectiveness NMA demonstrated that flecainide (SUCRA = 89.0%) is most likely to be superior for conversion within 4 h (27 studies; n = 2681), and ranolazine-amiodarone IV (SUCRA 93.7%) is most likely to be superior for conversion within 24 h (24 studies; n = 3213). Confidence in the NMA estimates is variable and limited mostly by within-study bias and imprecision.

CONCLUSIONS:

Among guideline-recommended antidysrhythmic drugs, the combination of digoxin IV and amiodarone IV is definitely among the least safe for cardioversion of recent onset AF; flecainide, vernakalant, ibutilide, propafenone, and amiodarone IV are definitely among the most effective for cardioversion within 4 h; flecainide is definitely among the most effective for cardioversion within 24 h. Further, randomized controlled trials with predetermined and strictly defined, hemodynamic adverse event outcomes are recommended.

2024-08-01·CLINICAL CARDIOLOGY

Effect of Obesity on the Use of Antiarrhythmics in Adults With Atrial Fibrillation: A Narrative Review

Review

作者: Castelino, Ronald L. ; Ferguson, Caleb ; Inglis, Sally C. ; Shaikh, Fahad ; Davidson, Patricia M. ; Wynne, Rochelle

ABSTRACT:

Background:

Atrial fibrillation (AF) and obesity coexist in approximately 37.6 million and 650 million people globally, respectively. The anatomical and physiological changes in individuals with obesity may influence the pharmacokinetic properties of drugs.

Aim:

This review aimed to describe the evidence of the effect of obesity on the pharmacokinetics of antiarrhythmics in people with AF.

Methods:

Three databases were searched from inception to June 2023. Original studies that addressed the use of antiarrhythmics in adults with AF and concomitant obesity were included.

Results:

A total of 4549 de‐duplicated articles were screened, and 114 articles underwent full‐text review. Ten studies were included in this narrative synthesis: seven cohort studies, two pharmacokinetic studies, and a single case report. Samples ranged from 1 to 371 participants, predominately males (41%–85%), aged 59–75 years, with a body mass index (BMI) of 23–66 kg/m2. The two most frequently investigated antiarrhythmics were amiodarone and dofetilide. Other drugs investigated included diltiazem, flecainide, disopyramide, propafenone, dronedarone, sotalol, vernakalant, and ibutilide. Findings indicate that obesity may affect the pharmacokinetics of amiodarone and sodium channel blockers (e.g., flecainide, disopyramide, and propafenone). Factors such as drug lipophilicity may also influence the pharmacokinetics of the drug and the need for dose modification.

Discussion:

Antiarrhythmics are not uniformly affected by obesity. This observation is based on heterogeneous studies of participants with an average BMI and poorly controlled confounding factors such as multimorbidity, concomitant medications, varying routes of administration, and assessment of obesity. Controlled trials with stratification at the time of recruitment for obesity are necessary to determine the significance of these findings.

2024-07-01·EBioMedicine

Advancing drug development for atrial fibrillation by prioritising findings from human genetic association studies

Article

作者: Providencia, Rui ; Lambiase, Pier D ; Finan, Chris ; Schilling, Richard ; Floriaan Schmidt, Amand ; Kukendrarajah, Kishore ; Farmaki, Aliki-Eleni

BACKGROUND:

Drug development for atrial fibrillation (AF) has failed to yield new approved compounds. We sought to identify and prioritise potential druggable targets with support from human genetics, by integrating the available evidence with bioinformatics sources relevant for AF drug development.

METHODS:

Genetic hits for AF and related traits were identified through structured search of MEDLINE. Genes derived from each paper were cross-referenced with the OpenTargets platform for drug interactions. Confirmation/validation was demonstrated through structured searches and review of evidence on MEDLINE and ClinialTrials.gov for each drug and its association with AF.

FINDINGS:

613 unique drugs were identified, with 21 already included in AF Guidelines. Cardiovascular drugs from classes not currently used for AF (e.g. ranolazine and carperitide) and anti-inflammatory drugs (e.g. dexamethasone and mehylprednisolone) had evidence of potential benefit. Further targets were considered druggable but remain open for drug development.

INTERPRETATION:

Our systematic approach, combining evidence from different bioinformatics platforms, identified drug repurposing opportunities and druggable targets for AF.

FUNDING:

KK is supported by Barts Charity grant G-002089 and is mentored on the AFGen 2023-24 Fellowship funded by the AFGen NIH/NHLBI grant R01HL092577. RP is supported by the UCL BHF Research Accelerator AA/18/6/34223 and NIHR grant NIHR129463. AFS is supported by the BHF grants PG/18/5033837, PG/22/10989 and UCL BHF Accelerator AA/18/6/34223 as well as the UK Research and Innovation (UKRI) under the UK government's Horizon Europe funding guarantee EP/Z000211/1 and by the UKRI-NIHR grant MR/V033867/1 for the Multimorbidity Mechanism and Therapeutics Research Collaboration. AF is supported by UCL BHF Accelerator AA/18/6/34223. CF is supported by UCL BHF Accelerator AA/18/6/34223.

项与盐酸维那卡兰相关的新闻（医药）

2025-11-08

·心在线

GW-ICC/AHS.25 | 国建萍教授：抗心律失常药物的过去、现在和未来

在心血管介入治疗技术飞速发展的当下，导管消融在疗效提升、能量优化、技术革新及术者操作水平精进等方面均取得了显著进展。即便如此，抗心律失常药物治疗在临床实践中依然占据至关重要的地位。第36届长城心脏病学大会暨亚洲心脏大会2025期间，中国人民解放军总医院国建萍教授围绕抗心律失常药物的过去、现在与未来展开了深度分享，为参会者梳理了该领域的发展脉络与前沿方向。抗心律失常药物的过去 20世纪70年代，来自英国牛津大学的Vaughan Williams教授首次对抗心律失常药物进行了分类（即Vaughan Williams分类法）： Ⅰ类，钠通道阻滞剂：主要作用是降低心肌兴奋性，当时对其认识较为局限，仅知晓其作用于钠离子通道。 Ⅱ类，G蛋白信号调节剂（β受体阻滞剂）：核心功能是降低交感神经兴奋性，最初被简单地归为β受体抑制剂。 Ⅲ类，钾通道阻滞剂：能够延长复极时间，早期已知的代表药物有胺碘酮、决奈达隆，但对其作用机制的认知较为浅显。 Ⅳ类，钙通道阻滞剂：通过影响钙离子发挥作用，当时并未对其进行更细致的分类研究。当时，电生理刚刚起步，心电图为主要诊断手段，受标测条件和对心脏认知的限制，人们对这四类抗心律失常药物的认识有限。在1975年之后的半个世纪里，随着医学技术的不断进步和对心脏生理机制研究的深入，学者们逐渐发现这四类抗心律失常药物存在诸多亚型，它们分别作用于不同的心脏离子通道、G蛋白偶联的不同受体以及钙离子相关通路，抗心律失常药物分类也随之不断扩展。抗心律失常药物的现在 1.抗心律失常药物使用框架《2025欧洲心律协会（EHRA）抗心律失常药物实用纲要》指出，抗心律失常药物治疗依然占据至关重要的地位，并给出了在不同场景下进行抗心律失常药物使用的框架（ABC指示）： A - Appropriate（适当治疗）：对于部分患者，药物治疗仍是最佳治疗方案；对于部分因经济条件受限或无法接受消融治疗的患者，药物治疗或为唯一选择。 B - Backup（备用治疗）：当导管消融失败或不可行时，抗心律失常药物治疗可作为后备治疗策略。 C - Complementary（互补治疗）：药物治疗可与导管消融/器械等治疗手段协同应用，具有“1 + 1＞2”的效果。 2.抗心律失常药物分类拓展与特点表1：《2025 EHRA抗心律失常药物实用纲要》给出的简化抗心律失常药物新分类随着研究的不断深入，抗心律失常药物分类逐渐扩展，目前已有8类：【0类】HCN通道阻滞剂作用机制：制窦房结（SAN）自律性，阻断超极化激活的环核苷门控通道（HCN）If电流，对心室肌没有影响。代表药物：伊伐布雷定。【Ⅰ类】电压门控钠离子通道阻断剂既往仅知道Ⅰ类抗心律失常药物作用于钠离子通道，近年来随着对钠离子通道结合和解离动力学等的了解，明确了不同药物对钠离子的解离速度不同，从而产生了不同的抗心律失常效果；并将Ⅰ类抗心律失常药物分为不同亚类。 Ⅰa类：机制：降低异位心房、心室自律性，减慢旁路传导，延长有效不应期，减少折返倾向。代表药物：奎尼丁、阿义马林、丙吡胺。 Ⅰb类：机制：降低异位心房、心室自律性；减低DAD诱导触发活动；单向和双向阻滞减少折返。代表药物：利多卡因、美西律。 Ⅰc类：机制：降低异位心房、心室自律性；减低DAD诱导触发活动；单向和双向阻滞减少折返，快速心室率时降低传导和兴奋性，阻断折返旁路。代表药物：普鲁帕酮、氟卡胺。 Ⅰd类：机制：减少动作电位恢复时间，减少早后除极和延迟后除极的触发活动。代表药物：雷诺嗪。【Ⅱ类】自主神经抑制剂和激动剂既往仅知道Ⅱ类抗心律失常药物是β受体抑制剂，现在已明确其可作用于G蛋白偶联的β受体、M受体及腺苷受体。 Ⅱa类：β肾上腺素受体阻滞剂，如阿替洛尔、比索洛尔、美托洛尔。 Ⅱb类：β肾上腺素能受体激动剂，如异丙肾上腺素。 Ⅱc类：毒蕈碱型M2受体抑制剂，如阿托品。 Ⅱd类：毒蕈碱型M2受体激动剂，如地高辛、洋地黄毒苷。 Ⅱe类：腺甘A1受体激动剂，如腺苷。【Ⅲ类】钾离子通道阻滞与开放剂既往仅知道Ⅲ类抗心律失常药物为钾离子通道阻滞剂，包括胺碘酮、决奈达隆等药物，随着研究的深入，目前明确其可作用于多靶点，不仅作用于钾离子，还可作用于钠离子和钙离子等。 Ⅲa类：非选择性钾通道阻滞剂，如胺碘酮。 HERG通道介导的快速钾离子电流阻滞剂，如多非利特、伊布利特、索他洛尔。 IKur钾离子通道阻滞剂，如维纳卡兰（Vernakalant）。 Ⅲb类：KATP钾离子通道开放剂，如尼可地平。 Ⅲc类：GIRK1和GIRK4阻滞剂，尚无获批药物。【Ⅳ类】钙离子触控调节剂 Ⅳa：表面膜非选择性及Cav1.2和Cav1.3通道介导的L型钙通道阻滞剂，如维拉帕米、地尔硫䓬。 Ⅳb：细胞内钙通道阻滞剂，无批准药物。【Ⅴ类】机械敏感性通道阻滞剂无获批药物，正在研发中。【Ⅵ类】缝隙连接通道阻滞剂无获批药物，正在研发中。【Ⅶ类】上游靶向调节剂代表药物包括血管紧张素转换酶抑制剂（ACEI）、血管紧张素受体脑啡肽酶抑制剂（ARNI）、盐皮质激素受体拮抗剂、钠-葡萄糖共转运蛋白-2（SGLT-2）抑制剂、他汀类药物等。图1. 抗心律失常药物的作用靶点相较于1975年发表的Vaughan Williams分类，抗心律失常药物新分类呈现出诸多新特点：从“单一靶点” 到 “多靶点协同” 以胺碘酮、决奈达隆为代表，既往人们对这类药物的作用靶点认知较为单一，如今发现其可作用于多靶点，不仅影响钾离子通道，还对钠离子、钙离子通道等产生作用，通过多靶点协同发挥抗心律失常效果。从 “下游干预” 到 “上游预防” 除针对心律失常发作本身进行治疗外，一些既往用于其他疾病治疗的药物也被发现具有抗心律失常的上游预防作用，如SGLT2抑制剂（既往用于降糖）、ACEI/ARB类药物（既往用于降压）、他汀类药物（既往用于调脂、抗炎）等，能够抑制炎症，抑制心肌纤维化，从源头减少心律失常的发生风险。从“电生理主导”到“结构代谢-信号整合” 心律失常药物分类中预留了第Ⅴ类和第Ⅵ类药物的席位，分别针对机械敏感通道（结构-电耦合）和缝隙连接通道（细胞间通讯）。目前这两类药物仍处于研发阶段，尚未应用于临床。从“药物研发”到“药物再定位” 即“老药新用”，一些原本用于其他疾病治疗的药物，在临床应用中被发现具有抗心律失常作用，如雷诺嗪最初用于抗心绞痛治疗，如今发现其可用于治疗心律失常。抗心律失常药物的发展 1.心房选择性机制药物研发选择性作用于心房，对心室没有影响或影响非常小，从而避免了抗心律失常药物导致的心律失常副作用，如AP30663和Doxapram。 (1) 小电导钙激活钾通道抑制剂（AP30663）其作用机制为抑制参与心房复极的通道，延长心房不应期。在实验模型中，该药物能够终止对维那卡兰抵抗的房颤，核心优势在于安全性高（对心室影响小）且具有心房选择性，主要应用于房颤转复。 (2) 多沙普仑多沙普仑是“老药新用”的代表药物之一，其为一种心房选择性药物，可通过抑制在房颤中表达上调的TASK1钾通道，延长心房不应期，减少房颤负荷，目前处于Ⅱ期临床试验阶段，主要用于房颤复律。 2.多离子通道组织剂探索临床医生一直期待能研发出一种 “胺碘酮升级版” 的多离子通道阻滞剂。这主要是因为胺碘酮的作用非常强大，疗效显著，但副作用限制了其临床应用。 (1) Sulcardine Sulcardine是一种多离子通道阻滞剂，能够抑制钠离子、钾离子等多个离子通道，作用类似雷诺嗪。可以缩短J点至T波峰的间隔，抑制早后除极（EADs）。 Sulcardine主要用于室性心律失常和房颤治疗，可通过静脉输注用于房颤终止。目前正在进行剂量探索研究，评估其终止房颤的疗效和安全性，且研究显示其可能降低尖端扭转型室性心动过速（TdP）风险（不显著延长QT间期）。值得一提的是，由于在相关研究报告中Sulcardine具有一些安全事件，因此之后未在更新Sulcardine相关研究报道。 (2) 布尼达隆（Budiodarone）布尼达隆是胺碘酮的改良版，其半衰期短，累积毒性相对较小，主要用于房颤预防。近期，该药物再次引起了研究人员的关注，计划开展更多临床研究，其快速清除的特性使其安全性优于胺碘酮。 3.快速起效药物开发快速起效药物对于新发心律失常的转复具有重要意义，能够及时缓解患者症状，为治疗争取时间。 (1) 依曲帕米（Etripamil）依曲帕米是一种新型L型钙通道阻滞剂，具有快速起效（Tmax≤7 min）和半衰期短的特点，可通过鼻喷雾给药，方便患者院外使用，有望成为“口袋药物”，但其具有局部鼻刺激等缺点。值得一提的是，依曲帕米除可转复房室结折返性心动过速外，对于新发房颤也有转复作用，目前仍在进行Ⅲ期临床试验，我们拭目以待。 (2) 吸入型氟卡尼吸入型氟卡尼可用于房颤转复，其可通过肺部快速吸收，能够显著缩短房颤转复时间，中位转复时间约12.8 min，优于口服制剂。然而，其或存在房扑转换伴1:1房室传导等潜在风险。该药物或可避免首过代谢，提高生物利用度，目前仍处于Ⅲ期临床试验阶段，结果如何我们拭目以待。 4.基因指导的个性化治疗推进精准医疗是未来医学发展的重要趋势，在抗心律失常药物领域，基因指导的个性化治疗（即精准治疗）能够根据患者的基因类型选择合适的药物，提高治疗效果，减少不良反应。 (1) 布新洛尔（Bucindolol）布新洛尔是一种非选择性β受体阻滞剂，可同时抑制α1肾上腺素能受体，引起血管舒张。研究发现，其可减少特定基因型（ADRB1 Arg/Arg）患者的新发房颤风险，主要用于心衰伴房颤患者的房颤预防。目前，该药物在特定人群（如心衰患者）中已显示出有效性，但尚未获得广泛批准，未来有望在基因检测指导下实现更精准的临床应用。 5.重新利用现有药物进一步挖掘现有药物的抗心律失常潜力，探索 “老药新用”的可能性。在临床实践中，密切关注药物使用过程中出现的意外治疗效果，及时开展相关研究，为抗心律失常治疗提供更多选择（如如Doxapram）。总体而言，关于新型抗心律失常药物的未来发展，可从优化现有药物、深化精准医疗和验证新型疗法三个方向努力，迈向更快速、更精准、更安全、更便捷的新时代。（特别鸣谢媒体合作伙伴：医脉通） GW-ICC/AHS 2025 点击阅读原文关注最新资讯

AHA会议

2024-12-02

·蒲公英Ouryao

最新粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录

转自：广东省药监局编辑：水晶 12月2日，广东省药监局网省消息，广东省药监局和广东省卫健委发布粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录（2024年）的通告。《通告》指出，本批目录收录34个上市药品及37个医疗器械。对已列入目录的药械产品，将于2024年12月1日起按照《条例》第九条进行管理。 34个药品：卡那奴单抗、维莫德吉胶囊、盐酸维那卡兰注射液、阿仑珠单抗、罗氟司特片、氨己烯酸薄膜衣片、卡博替尼薄膜衣片、阿培利司薄膜衣片、厄达替尼片、注射用羟钴胺素、布西珠单抗、伊匹木单抗注射液、巴氯芬注射液、艾沙妥昔单抗注射用浓缩液、肾上腺素注射液（预充笔）、莱博雷生片、瑞玛奈珠单抗、硫酸瑞美吉泮口崩片、注射用坦昔妥单抗、二十碳五烯酸乙酯软胶囊、阿扎胞苷片、曲美木单抗、注射用芦比替定、阿司福酶α注射液、阿伏利尤单抗、特泽利尤单抗、磷酸芦可替尼乳膏、罗莫佐单抗、重组人促卵泡素α/促黄体素α注射液、注射用重组人促卵泡素α/促黄体素α、艾普奈珠单抗、伊曲莫德片、依洛硫酸酯酶α注射液、维替索妥尤单抗。根据《广东省粤港澳大湾区内地九市进口港澳药品医疗器械管理条例》（以下简称《条例》）中对急需港澳药械实施目录管理的要求，广东省药品监督管理局、广东省卫生健康委员会经研究决定发布广东省粤港澳大湾区内地九市临床急需港澳药品医疗器械目录（2024年）。本批目录将按《国家药品监督管理局国家卫生健康委员会关于临床急需境外新药审评审批相关事宜的公告》（2018年第79号）发布并符合《条例》要求的港澳已上市药品及《条例》实施前已批准的共71个药品及医疗器械收录。对已列入目录的药械产品，将于2024年12月1日起按照《条例》第九条进行管理。特此通告。附件：1.广东省粤港澳大湾区内地九市临床急需进口港澳药品目录（2024年） 2.广东省粤港澳大湾区内地九市临床急需进口港澳医疗器械目录（2024年）广东省药品监督管理局广东省卫生健康委员会 2024年11月29日

2022-08-29

·BioSpace

Hypertrophic Cardiomyopathy Therapeutics Market is Expected To Reach USD 1.42 Billion By 2027 at a CAGR of 2.1%

According to the current analysis of Reports and Data, the global Hypertrophic Cardiomyopathy Therapeutics Market valued at USD 1.20 Billion in 2019 and is expected to reach USD 1.42 billion by the year 2027, at a CAGR of 2.1%. Hypertrophic cardiomyopathy (HCM) alters the functioning of the heart. Increasing prevalence of cardiovascular disorders, lifestyle habits like smoking and consumption of alcohol, obesity, and growth in the geriatric populations are the factors driving the growth of the market. However, the high-cost expenditure of treatment is restraining the market. According to the report, the World Health Organization (WHO) estimated that 17.9 million people died from cardiovascular diseases in the year 2016, which includes approximately 31% of all global deaths. According to the WHO, in 2016, more than 1.9 billion adults aged 18 years and older were overweight. Regionally, in Africa, the number of overweight children under five has increased by nearly 50% since 2000. Approximately half of the children under five who were overweight or obese in 2018 lived in Asia. The prevalence of obesity among children and adolescents aged 5-19 has risen dramatically. According to Canadian Community Health Survey, in 2018, nearly 63.1% of Canadian adults were either obese or overweight, in which approximately 26.8%, i.e., 7.3 million adults, were obese and another 9.9 million, i.e., 36.3% of Canadian adults were overweight. In 2019 approximately 35% of Americans were obese or overweight in the United States. Access Free sample PDF Copy of the Report (To Understand the Complete Structure of this Report [Summary + TOC]) @ Asia Pacific region is likely to increase the market growth due to factors like an increase in the patient population, lifestyle habits like smoking and consumption of alcohol and, rise in the geriatric population, etc. Further key findings from the report suggest In the year 2019, Correvio Pharma had resubmitted the New Drug Application (NDA) for Brinavess (vernakalant hydrochloride) for the treatment of cardiac arrhythmias to the Food and Drug Administration. But the FDA issued a CRL letter to Correvio Pharma and rejected Brinavess (vernakalant hydrochloride) as it was seen that the drug had prolonged atrial refractoriness and slowed the impulse conduction in a rate-dependent fashion, but the data provided in the application did not provide reassurance of the safety. The NYIT College of Osteopathic Medicine (NYITCOM) researchers, offered a new treatment for patients with beta-blocker intolerance, here T3 (thyroid hormone therapy) was used in the treatment. It is an effective method for managing cardiovascular disorders, and showed better contraction and relaxation of the heart, and was found to be a better treatment for patients. Strokes are one of the causes of hypertrophic cardiomyopathy. In February 2020, the FDA had approved a clinical trial that on Abbott's Amplatzer Amulet, a stroke prevention device it was found to be more beneficial than the new class of blood thinners that are currently used in the treatment. It involves a minimally invasive procedure used for patients with atrial fibrillation. It is an effective non-prescription drug alternative for patients with arterial fibrillation who are at an increased risk for ischemic stroke. Medtronicin January 2020, had announced that it had received the CE Mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D).ICDs are used to monitor heart rhythms and supply proper therapy to correct heart rates that are too fast that lead to sudden cardiac arrest. CRT-Ds is a treatment option for some individuals with heart failure; it sends small electrical impulses to the lower chambers of the heart to support them beat in more synchronized patterns and to reduce arrhythmia symptoms. Merck in the year 2019 announced an acquisition of ArQule for arround USD 2.7 billion. This acquisition had strengthened Merck's pipeline it and also included ARQ 531 for the treatment of B-cell malignancies. By Drugs segment, the antiarrhythmic drugs have obtained the largest share of about 36.4% in the year 2019, due to the rise in the incidences of cardiac arrhythmias and also due to the lifestyle factors like smoking and consumption of alcohol On the basis of devices defibrillators accounted for USD 598.3 million for the year 2019. The ongoing pandemic is significantly changing the dynamics of the pharma and healthcare sector. Various countries are facing challenges such as shortage of medicines, vaccines, healthcare devices in hospitals. This is expected to open lucrative growth opportunities for market players in the coming years. For Inquiry Before Buying @ Competitive Landscape: The global market comprises various market players operating at regional and global levels. These key players are adopting various strategies such as R&D investments, license agreements, partnerships, merger and acquisitions, collaborations, and joint ventures to gain robust footing in the market. Top Companies Profiled in the Report: AstraZeneca, Merck, Pfizer, Sanofi, Gilead Sciences, Novartis, Teva Pharmaceutical, Correvio Pharma Industries, Abbot, Lupin limited Browse Full Report Description with Research Methodology, Table of Content and Infographics @ Hypertrophic Cardiomyopathy Therapeutics Market Segmentation: Drugs Outlook (Revenue in Million USD; (2017–2027) Antiarrhythmic Agents Anticoagulants Beta-Adrenergic Blocking Agents Calcium Channel Blockers Others Devices Outlook (Revenue in Million USD; (2017–2027) Defibrillators Pacemakers Other Medical Devices End Use Outlook (Revenue in Million USD; (2017–2027) Hospitals Clinics Others Regional Outlook: North America (U.S., Canada, Mexico) Europe (Germany, U.K., Italy, France, BENELUX, Rest of Europe) Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific) Latin America (Brazil, Rest of LATAM) Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa) Ask for Customize Research Report @ This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth. 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疫苗并购合作

100 项与盐酸维那卡兰相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06665	盐酸维那卡兰	C01BG11	DB06217

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心房颤动	欧盟	Advanz Pharma Corp. Ltd.	2010-09-01
心房颤动	冰岛	Advanz Pharma Corp. Ltd.	2010-09-01
心房颤动	列支敦士登	Advanz Pharma Corp. Ltd.	2010-09-01
心房颤动	挪威	Advanz Pharma Corp. Ltd.	2010-09-01
心律失常	加拿大	Cardiome UK Ltd.	-

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
房性心律失常	临床3期	美国	Advanz Pharma Corp. Ltd.	2004-06-01
房性心律失常	临床3期	美国	Astellas Pharma, Inc.	2004-06-01
房性心律失常	临床3期	阿根廷	Advanz Pharma Corp. Ltd.	2004-06-01
房性心律失常	临床3期	阿根廷	Astellas Pharma, Inc.	2004-06-01
房性心律失常	临床3期	加拿大	Astellas Pharma, Inc.	2004-06-01
房性心律失常	临床3期	加拿大	Advanz Pharma Corp. Ltd.	2004-06-01
房性心律失常	临床3期	丹麦	Advanz Pharma Corp. Ltd.	2004-06-01
房性心律失常	临床3期	丹麦	Astellas Pharma, Inc.	2004-06-01
房性心律失常	临床3期	印度	Astellas Pharma, Inc.	2004-06-01
房性心律失常	临床3期	印度	Advanz Pharma Corp. Ltd.	2004-06-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SPECTRUM (ESC2019)	N/A	心房颤动	-	Vernakalant	艱衊蓋憲糧遞艱鏇壓製(鏇鬱衊選壓壓鬱鹽蓋齋) = 觸製鏇醖淵膚夢鑰襯淵積淵積網夢鹽製繭蓋範 (範製餘糧顧襯壓獵繭醖, 68.1–72.2) 更多	-	2019-09-02
NCT01174160 (Pubmed \| Am J Cardiol) 人工标引	临床3期	心房颤动	111	Vernakalant	構艱襯窪壓膚觸醖鬱鏇(網壓鬱範糧積壓蓋膚窪) = 淵遞淵餘衊製憲觸遞鬱夢襯鏇窪夢獵醖範顧繭 (憲簾繭醖獵鏇鑰齋願膚 )	积极	2017-02-01
				Placebo	構艱襯窪壓膚觸醖鬱鏇(網壓鬱範糧積壓蓋膚窪) = 鏇夢鹽鹹遞襯襯壓壓顧夢襯鏇窪夢獵醖範顧繭 (憲簾繭醖獵鏇鑰齋願膚 )
NCT01447862 (Pubmed \| Europace)	临床4期	心房颤动	100	Vernakalant	廠鏇廠獵網壓繭鹽醖淵(醖簾窪願繭觸願選選鹹) = 壓襯遞遞鹽憲鏇壓願鏇觸淵夢網顧選糧蓋構艱 (積選積繭夢衊範繭簾獵 ) 更多	积极	2017-02-01
				Ibutilide	廠鏇廠獵網壓繭鹽醖淵(醖簾窪願繭觸願選選鹹) = 醖簾鏇憲壓繭餘蓋餘壓觸淵夢網顧選糧蓋構艱 (積選積繭夢衊範繭簾獵 ) 更多
NCT00989001 (ACT V, Pubmed \| BMC Cardiovasc Disord) 人工标引	临床3期	心房颤动	217	vernakalant	繭鏇獵餘膚壓蓋獵襯網(獵艱醖壓鏇夢鏇艱糧餘) = 鑰窪願築遞鏇獵廠衊壓鹽簾鑰繭範壓獵範壓壓 (齋夢築蓋繭網積顧製廠 )	积极	2016-05-28
				Placebo	繭鏇獵餘膚壓蓋獵襯網(獵艱醖壓鏇夢鏇艱糧餘) = 醖醖淵遞糧壓廠衊顧願鹽簾鑰繭範壓獵範壓壓 (齋夢築蓋繭網積顧製廠 )
NCT01174160 (CTgov)	临床3期	心房颤动	123	Placebo to vernakalent hydrochloride	鏇鹹餘鬱觸蓋鏇選醖糧 = 壓醖獵醖遞淵願鏇構顧鹽窪糧餘艱窪鹽鏇鹹積 (夢積遞願築觸網獵鏇襯, 築膚壓範範鏇觸餘遞積 ~ 艱衊觸構獵糧鏇鹹餘窪) 更多	-	2015-12-15
NCT00476112 (Pubmed \| Europace)	临床2/3期	心房扑动	60	Vernakalant	築鬱糧願窪醖觸鑰願淵(膚獵糧鬱積糧繭築網鬱) = 製齋簾鹹壓繭選鬱獵築廠願鬱夢齋艱鏇壓膚鑰 (衊淵簾積夢艱淵顧鏇範 )	不佳	2012-06-01
NCT00668759 (AVRO, Pubmed \| J Am Coll Cardiol)	临床3期	心房颤动	254	Vernakalant	壓遞繭簾構餘膚顧範齋(鹽艱醖齋觸蓋網繭鏇壓) = 顧範網遞齋願窪築構簾顧積築膚壓壓窪艱簾醖 (鏇鏇鹹衊衊蓋網膚廠網 )	积极	2011-01-18
				Amiodarone	壓遞繭簾構餘膚顧範齋(鹽艱醖齋觸蓋網繭鏇壓) = 鹹膚鏇積鑰鑰鑰醖觸夢顧積築膚壓壓窪艱簾醖 (鏇鏇鹹衊衊蓋網膚廠網 )
NCT00281554 \| NCT00468767 (ACT I and ACT IV, Pubmed \| Acad Emerg Med)	临床3期	心房颤动	290	Vernakalant	鏇遞糧繭蓋蓋襯憲衊積(鹽觸襯窪襯憲觸淵鬱選) = 壓艱壓顧鹹襯簾遞壓餘憲製壓糧醖簾遞遞襯廠 (壓顧簾醖齋齋遞構繭夢 )	积极	2010-11-01