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Last update 20 Mar 2025

Amiodarone Hydrochloride

Last update 20 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAmiodarone, also known as CORDARONE, is an antiarrhythmic drug developed in 1961 by chemists Tondeur and Binon. By 1980, it was commonly prescribed throughout Europe for the treatment of arrhythmias. In December 1985, due to the threat of a cut-off from European companies, amiodarone was approved by the FDA for the treatment of arrhythmias, even though it had not undergone rigorous randomized clinical trials. Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. It blocks sodium and myocardial potassium channels, contributing to slowing of conduction and prolongation of refractoriness. CORDARONE is indicated for the treatment of life-threatening ventricular fibrillation and unstable tachycardia in adults who have not responded to other antiarrhythmics.

Drug Type

Small molecule drug

Synonyms

2-Butyl-3-(3,5-diiodo-4-(2-diethylaminoethoxy)benzoyl)benzofuran, 2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone, 2-n-Butyl-3',5'-diiodo-4'-N-diethylaminoethoxy-3-benzoylbenzofuran

+ [14]

Target

Potassium channel x Sodium channels x VDCCs x β-adrenoceptors

Action

blockers, antagonists

Mechanism

Potassium channel blockers, Sodium channels blockers, VDCCs blockers(Voltage-gated calcium channel blockers)

+ [1]

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Heart ArrestAtrial FibrillationTachycardia, Ventricular+ [2]

Inactive Indication

Heart Failure

Originator Organization

Labaz

Active Organization

Guilin Pharmaceutical Co., Ltd.Baxter Healthcare Corp.Sanofi KK

+ [1]

Inactive Organization

Wyeth AB

Prism Pharmaceuticals, Inc.Wyeth Pharmaceuticals LLC

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 1983),

Arrhythmias, Cardiac

RegulationOrphan Drug (Japan)

Structure/Sequence

Molecular FormulaC25H29I2NO3

InChIKeyIYIKLHRQXLHMJQ-UHFFFAOYSA-N

CAS Registry1951-25-3

View All Structures (2)

158

Clinical Trials associated with Amiodarone Hydrochloride

NCT01422148

/ Not yet recruitingPhase 2IIT

Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery (MINA)

. New- onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and its occurrence increases with age. POAF can result in clinically significant morbidity and mortality. The national trend in the US is that the population older than 65 years is increasing, making healthcare expenditure related to POAF to be a major burden on health care system. Effective treatment of POAF is imperative in ensuring quality of care and reduction of costs.
In 2021 there is a projected total of 377,763 cardiovascular surgeries in the US alone with approximately half of which will have POAF with longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients (Reference: Ann Thorac Surg. 2015 Jan;99(1):109-14). Amiodarone, the currently used therapy, is often insufficient to prevent POAF and has multiple side-effects. In this study, we expect to improve the incidence of POAF by using a common acne drug (Minocycline) that is safe and that could be incorporated in clinical care of this disease.

Start Date01 Jul 2025

Sponsor / Collaborator

Baystate Medical Center

NCT06835491

/ Not yet recruitingPhase 3IIT

Prophylactic Anti-aRrhythmic Therapy with Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest with Initial Shockable Rhythm.

To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)

Start Date15 Jun 2025

Sponsor / Collaborator

Centre Hospitalier de Versailles

NCT06722196

/ Not yet recruitingPhase 3IIT

BiodEgradable Soaked Amiodarone PaTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery

The primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium results in a reduction in the incidence of POAF

Start Date15 Jan 2025

Sponsor / Collaborator

Cornell University

100 Clinical Results associated with Amiodarone Hydrochloride

100 Translational Medicine associated with Amiodarone Hydrochloride

100 Patents (Medical) associated with Amiodarone Hydrochloride

14,518

Literatures (Medical) associated with Amiodarone Hydrochloride

31 Dec 2025·Scandinavian Cardiovascular Journal

The use of antiarrhythmic drugs for atrial fibrillation in Finland 2007–2018

Article

Author: Linna, Miika ; Aro, Aapo ; Salmela, Birgitta ; Mustonen, Pirjo ; Lappalainen, Antti ; Putaala, Jukka ; Marjamaa, Annukka ; Halminen, Olli ; Hartikainen, Juha ; Haukka, Jari ; Virrankorpi, Janne ; Teppo, Konsta ; Siponen, Rasmus ; Airaksinen, Juhani ; Lehto, Mika

BackgroundPatients with atrial fibrillation (AF) are often treated with antiarrhythmic drugs (AADs) to maintain sinus rhythm and with heart rate-lowering drugs to achieve optimal rate control. In this study we investigated trends in the use of AADs and rate control drugs in Finnish patients with AF.Methods and resultsThe Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) study is a nationwide study including all patients with AF in Finland from 2007 to 2018. The number of AAD purchases and the proportions of all prevalent AF patients in a certain year of interest were calculated.In total, 391030 AF patients were identified between 2007 and 2018, and 39816 (10.2%) of them had purchased either class I or III AADs. The proportion of patients using class I and III AADs decreased from 8.6% to 6.3%. Flecainide and amiodarone were the most often used AADs. The use of flecainide and amiodarone decreased from 4.9% to 3.9% and 1.9% to 1.5%, respectively. The proportion of patients on beta-blockers remained stable at 75%. Dronedarone became available in 2011 when it also was the most used (0.8% of patients), but the use decreased thereafter. The use of sotalol and digoxin decreased from 1.5% to 0.6% and 24.6% to 11.0% over the study period.ConclusionThe number of AAD purchases increased alongside with the increasing prevalence of AF, whereas the proportion of AF patients on class I and III AADs and digoxin decreased between 2007 and 2018. Flecainide remained the most used AAD followed by amiodarone.

31 Dec 2025·Redox Report

Artemisinin protected human bronchial epithelial cells from amiodarone-induced oxidative damage via 5′-AMP-activated protein kinase (AMPK) activation

Article

Author: Zhao, Xia ; Xiong, Wenjun ; Zheng, Wenhua ; Liang, Guang ; Yang, Chao ; Dong, Jiayi

BACKGROUNDAmiodarone, a common antiarrhythmic drug, is known for its severe side effects, including pulmonary toxicity, which involves oxidative stress and apoptosis. Artemisinin, an antimalarial drug, has shown cytoprotective properties by inhibiting oxidative stress and apoptosis. This study investigated the protective effects of artemisinin against amiodarone-induced toxicity in human bronchial epithelial cells (BEAS-2B) and mouse models.RESULTSIn vitro experiments revealed that amiodarone decreased cell viability, increased LDH release, ROS generation, caspase 3 activation, and apoptosis in BEAS-2B cells. Artemisinin counteracted these effects by upregulating p-AMPK, CaMKK2, Nrf2, and SOD1 protein levels, thereby protecting the cells from oxidative damage. The protective effect of artemisinin was diminished by the AMPK inhibitor Compound C or AMPKα knockdown. In vivo experiments demonstrated that artemisinin increased p-AMPK and Nrf2 protein levels in lung tissues, protecting against amiodarone-induced apoptosis and bronchial epithelial cell shedding in mice.CONCLUSIONThese findings suggest that artemisinin protects airway epithelial cells and lung tissue from amiodarone-induced oxidative stress and apoptosis through AMPK activation, offering potential new strategies for preventing and treating amiodarone-induced pulmonary toxicity.

01 Mar 2025·Resuscitation

A retrospective ‘target trial emulation’ comparing amiodarone and lidocaine for adult out-of-hospital cardiac arrest resuscitation

Article

Author: Shukis, Michael ; Price, Bradley S ; Bardes, James ; Crowe, Remle ; Martin, P S ; Scheidler, James ; Smida, Tanner

OBJECTIVEThe administration of amiodarone or lidocaine is recommended during the resuscitation of out-of-hospital cardiac arrest (OHCA) patients presenting with defibrillation-refractory or recurrent ventricular fibrillation or ventricular tachycardia. Our objective was to use 'target trial emulation' methodology to compare the outcomes of patients who received amiodarone or lidocaine during resuscitation.METHODSAdult, non-traumatic OHCA patients in the ESO Data Collaborative 2018-2023 datasets who experienced OHCA prior to EMS arrival, presented with a shockable rhythm, and received amiodarone or lidocaine during resuscitation were evaluated for inclusion. We used propensity score matching (PSM) to investigate the association between antiarrhythmic and outcomes. Return of spontaneous circulation (ROSC) was the primary outcome. Secondary outcomes included the number of post-drug defibrillations and survival to hospital discharge.RESULTSAfter application of exclusion criteria, 23,263 patients from 1,707 EMS agencies were eligible for analysis. Prior to PSM, 6,010/20,284 (29.6%) of the patients who received amiodarone and 1,071/2,979 (35.9%) of the patients who received lidocaine achieved prehospital ROSC. Following PSM, lidocaine administration was associated with greater odds of prehospital ROSC (36.0 vs. 30.4%; aOR: 1.29 [1.16, 1.44], n = 2,976 matched pairs). Lidocaine administration was also associated with fewer post-drug defibrillations (median: 2 [0-4] vs. 2 [0-6], mean: 3.3 vs. 3.9, p < 0.01, n = 2,976 pairs), and greater odds of survival to discharge (35.1 vs. 25.7%; OR: 1.54 [1.19, 2.00], n = 538 pairs).CONCLUSIONOur 'target trial emulation' suggested that lidocaine was associated with greater odds of prehospital ROSC in comparison to amiodarone when administered during resuscitation from shock refractory or recurrent VF/VT.

News (Medical) associated with Amiodarone Hydrochloride

22 Jan 2025

·www.prnewswire.com

Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. Acute Coronary Syndrome Pipeline Acute Coronary Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute coronary syndrome companies, including Janssen Research & Development, LLC, DalCor Pharmaceuticals, Hyloris Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalLicense out/in

16 Jan 2025

·www.prnewswire.com

Late-breaking data presented at AF Symposium 2025 highlight key Boston Scientific therapies for management of patients with atrial fibrillation

First phase of ADVANTAGE AF clinical trial achieves safety and effectiveness endpoints for treatment of drug-resistant, symptomatic, persistent atrial fibrillation with the FARAPULSE™ Pulsed Field Ablation System Sub-analysis from OPTION clinical trial highlights consistent safety and efficacy outcomes with the WATCHMAN FLX™ Left Atrial Appendage Closure Device post cardiac ablation in both concomitant and sequential procedures MARLBOROUGH, Mass., Jan. 16, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced data supporting the use of the FARAPULSE™ Pulsed Field Ablation (PFA) System* and the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device, respectively, during a late-breaking science session at AF Symposium 2025. ADVANTAGE AF clinical study Currently, the FARAPULSE PFA System is approved for pulmonary vein isolation (PVI) in patients who have paroxysmal AF, an irregular heartbeat that occurs occasionally and typically spontaneously resolves back to normal rhythm. The ADVANTAGE AF study examined use of the FARAPULSE PFA System for both PVI and posterior wall ablation (PWA) in patients who have persistent AF, where individuals experience an irregular or rapid heartbeat that lasts longer than seven days and which represent 25% of all AF cases.1 The prospective, single arm trial included 260 patients enrolled at 43 global sites who were drug intolerant to at least one Class I/III anti-arrhythmic drug (AAD). Key findings from the study through 12 months included: The primary safety endpoint – defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure and pulmonary vein stenosis or atrio-esophageal fistula out to 12 months – was met with a 2.3% event rate. The primary effectiveness endpoint – defined as freedom from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AAD or amiodarone – was met at 63.5%. The symptomatic AF recurrence-free rate was 85.3% and observationally, among physicians that performed three or more procedures, the symptomatic recurrence-free rate increased to 91.8%. There were no reported incidences of stroke, pulmonary vein stenosis, atrio-esophageal fistula or major access complications. "In addition to the positive safety and efficacy outcomes achieved in the ADVANTAGE AF study, a significant number of patients were able to discontinue AADs as well as see greater improvements in quality of daily life," said Vivek Reddy, M.D.**, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York and study principal investigator. "As the population of patients living with AF continues to grow, data from trials such as ADVANTAGE AF further support the paradigm shift to PFA as a treatment for patients who are living with persistent and other complex forms of AF." OPTION trial sub-analysis The late-breaking session also included a prespecified sub-analysis from the OPTION clinical trial that built upon the positive primary endpoint results presented at the American Heart Association 2024 meeting and published in The New England Journal of Medicine.2 In line with the overall 36-month outcomes from this first head-to-head study of the WATCHMAN FLX device and direct oral anticoagulants (95% DOAC, 5% warfarin), the sub-analysis of 1,600 patients with atrial fibrillation who underwent a device implantation either concomitantly or sequentially (90-180 days post ablation) demonstrated: Consistent with the previously presented primary safety and efficacy endpoint data presented in November 2024, concomitant LAAC with the WATCHMAN FLX device following an ablation demonstrated a statistically significant 44% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.0% vs. 13.3%; p=0.02) and similar efficacy outcomes (7.0% vs. 6.7% p=0.91), with the primary efficacy endpoint defined as all-cause death, stroke or systemic embolism. Also consistent with the previously presented primary safety and efficacy endpoint data, sequential LAAC with the WATCHMAN FLX device following an ablation demonstrated a statistically significant 62% reduction in non-procedural bleeding outcomes compared to OAC at 36 months (8.8% vs. 21.5%; p<0.0001) and similar efficacy outcomes (4.2% vs. 5.3%; p=0.45). Similar stroke protection with the WATCHMAN FLX device compared to OAC irrespective of concomitant (2.3% vs. 2.5% rates of all stroke) or sequential (1.1% vs 1.6%) implantation. "These late-breaking studies provide valuable clinical evidence supporting our ablation and stroke prevention technologies that are designed to improve long-term outcomes for patients with atrial fibrillation," said Dr. Brad Sutton, M.D., chief medical officer, Atrial Fibrillation Solutions, Boston Scientific. "The positive findings support our focus on expanding the number of patients who can benefit from these life-changing therapies, which we will continue to advance through future clinical trials and product development." More information on the ADVANTAGE AF study is available here and on the OPTION trial here.*** About Boston Scientific Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and connect on LinkedIn and X, formerly Twitter. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact, clinical trials, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document. CONTACTS: Becca Johnson Media Relations +1 (952) 994-8526 [email protected] Jon Monson Investor Relations +1 (508) 683-5450 [email protected] *CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation beyond pulmonary vein isolation is outside the use of labeled indication of the FARAWAVE PFA Catheter with the FARAPULSE PFA System. **Dr. Vivek Reddy is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release. *** The FARAPULSE PFA System was not commercially available at the time of the OPTION trial initiation and was not included in the trial design. 1Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213-220. doi: 10.2147/CLEP.S47385 2 Wazni OM, Saliba WI, Nair DG, et al. Left atrial appendage closure after ablation for atrial fibrillation. N Engl J Med. 2024 Nov 16. doi:10.1056/NEJMoa2408308 SOURCE Boston Scientific Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultClinical StudyAHA

22 Nov 2024

·www.drugs.com

AHA: Initial Catheter Ablation Beneficial for Ventricular Tachycardia

FRIDAY, Nov. 22, 2024 -- An initial strategy of catheter ablation leads to a lower risk for a composite primary end point than antiarrhythmic drug therapy among patients with ischemic cardiomyopathy and ventricular tachycardia, according to a study published online Nov. 16 in the New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions 2024, held from Nov. 16 to 18 in Chicago. John L. Sapp, M.D., from Dalhousie University in Halifax, Nova Scotia, Canada, and colleagues randomly assigned 416 patients with previous myocardial infarction and clinically significant ventricular tachycardia to receive antiarrhythmic drug therapy (sotalol or amiodarone) or to undergo catheter ablation, performed within 14 days after randomization. Patients were followed for a median of 4.3 years. The researchers found that a primary end point occurred in 50.7 percent of the 203 patients assigned to catheter ablation and 60.6 percent of the 213 assigned to drug therapy (hazard ratio, 0.75). Among patients in the catheter ablation group, adverse events within 30 days included death and nonfatal adverse events (1.0 and 11.3 percent, respectively). Among patients assigned to drug therapy, adverse events attributed to antiarrhythmic drug treatment included death from pulmonary toxic effects and nonfatal adverse events (0.5 and 21.6 percent, respectively). "Catheter ablation and antiarrhythmic drug therapy can reduce the risk of recurrent ventricular tachycardia and implantable cardioverter-defibrillator shock, but both approaches are associated with adverse events and have imperfect efficacy," the authors write. "Determining when to use these therapies is an important clinical decision." Several authors disclosed ties to pharmaceutical companies, including Johnson & Johnson and Abbott, which provided research grants.

AHAClinical Study

100 Deals associated with Amiodarone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00636	Amiodarone Hydrochloride	C01BD01	DB01118

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Arrest	Japan	Sanofi KK	31 May 2013
Atrial Fibrillation	Japan	Sanofi KK	03 Jul 1992
Tachycardia, Ventricular	Japan	Sanofi KK	03 Jul 1992
Ventricular Fibrillation	Japan	Sanofi KK	03 Jul 1992
Arrhythmias, Cardiac	China	Guilin Pharmaceutical Co., Ltd.	01 Jan 1983

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	Phase 2	-	Prism Pharmaceuticals, Inc.	01 Aug 2008
Atrial Fibrillation	Discovery	Canada	Wyeth AB	01 Feb 1999

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01722942 (CHAGASICS, Pubmed \| JAMA Cardiol) Manual	Not Applicable	Cardiomyopathies	323	Amiodarone	(gqbiwnswtl) = dlqidorrbz flhdhntzup (wychtxdytf ) View more	Negative	02 Oct 2024
				amiodarone	(gqbiwnswtl) = bsfhhtpimr flhdhntzup (wychtxdytf ) View more
NCT03029169 (Pubmed \| Eur Heart J Acute Cardiovasc Care)	Phase 4	Shock, Septic \| Supraventricular arrhythmias left atrial volume (LAVI)	-	Propafenone	rjruwcyvjx(sewampcptk): HR = 0.6 (95% CI, 0.4 - 0.9), P-Value = 0.014	Positive	19 Feb 2024
				Amiodarone
NCT05004077 (RADICAL, CTgov)	Phase 4	Atrial Fibrillation	3	Amiodarone (Conventional Amiodarone Dosing Regimen (CDR))	jffyactlfs(gqbjsulxlu) = murvavigyp prlsjjobqt (yoadwqldko, uviojqxqzx - ofkuywpubq) View more	-	18 Nov 2023
				Amiodarone (Repeated Amiodarone Bolus Dosing Regimen (RBDR))	jffyactlfs(gqbjsulxlu) = qmwgadxpww prlsjjobqt (yoadwqldko, mtsqysdzep - jazuuifchl) View more
German DEVICE-registry (ESC2023)	Not Applicable	-	-	Beta-blockers plus amiodarone	bmujzhgupn(ncgmubmqnb) = amiodarone was not associated with a significantly reduced risk of ICD discharges lemzweqczv (fyhhrddlqp ) View more	-	28 Aug 2023
ESC2023	Not Applicable	Left ventricular systolic dysfunction	-	Bepridil	vcezjotcxc(aaflygllpc) = ojlwjiuwyn ogaegronsi (eqzizfbkeq ) View more	-	26 Aug 2023
				Amiodarone	vcezjotcxc(aaflygllpc) = lvehbqhodv ogaegronsi (eqzizfbkeq ) View more
ESC2023	Not Applicable	Atrial Fibrillation First line	-	Amiodarone	(wrhtbhvbcf): hazard ratio = 2.52 (95% CI, 2.202 - 2.883)	Negative	25 Aug 2023
				Other-AADs
ATS2023	Not Applicable	Myxedema coma	-	Amiodarone	yflhllktyb(tnhoqvatbw) = She was hypotensive, hypothermic (35.0°C) and bradycardic with a heart rate of 40 beats per minute yyrniwuorw (edsptcvmon ) View more	-	21 May 2023
				Levothyroxine
PSAT335 (ENDO2022)	Not Applicable	Thyrotoxicosis	-	Amiodarone	oipeczsggj(pnxazxtpwn) = ryepitfhfu tkffhqfxpo (cavxxtjrri ) View more	-	01 Nov 2022
PSUN38 (ENDO2022)	Not Applicable	-	-	amiodarone (Thyrotoxicosis)	didvtrdotb(dvkrmcunjb) = novpjjpcww fvmxnwdgdl (wasihyzhbj ) View more	Positive	01 Nov 2022
				amiodarone (Hypothyroidism)	didvtrdotb(dvkrmcunjb) = rapcthjppq fvmxnwdgdl (wasihyzhbj )
ESC2022	Not Applicable	Lung Cancer	-	Amiodarone treatment	pftsizvlng(whavefbcyp) = bydeyaqsvw thwalskkro (gvlqnyztln )	-	29 Aug 2022
				Amiodarone	pftsizvlng(whavefbcyp) = ppswevlkdd thwalskkro (gvlqnyztln )

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