dronedarone / Generic mfg. - LARVOL DELTA

DRIVE-AF: Dronedarone Rhythm Intervention for Early Atrial Fibrillation (clinicaltrials.gov) - P4 | N=1898 | Not yet recruiting | Sponsor: Inha University Hospital

HEOR • New P4 trial • Atrial Fibrillation • Cardiovascular

Impact of Dronedarone on Early Recurrence After Catheter Ablation in Patients With Nonparoxysmal Atrial Fibrillation. (PubMed, Cardiovasc Ther) - "In this retrospective study of patients with nonparoxysmal atrial fibrillation after catheter ablation, dronedarone and amiodarone showed a trend toward better efficacy than propafenone in preventing overall early recurrence. Dronedarone demonstrated a specific advantage in preventing early recurrence of atrial flutter."

Clinical • Journal • Retrospective data • Atrial Fibrillation • Cardiovascular

The antiarrhythmic drugs dronedarone and amiodarone exhibit potent in vitro and in vivo activity against Clostridioides difficile. (PubMed, Int J Antimicrob Agents) - "In a time-kill assay, DRO outperformed the approved drugs, vancomycin (VAN) and fidaxomicin (FDX), reducing the high bacterial inoculum below the limit of detection within 2 h. Additionally, both drugs were more effective than VAN at preventing the formation and germination of C. difficile spores. Our findings suggest that these antiarrhythmic drugs have potential as compelling lead molecule for CDI drug discovery, warranting further investigation and potentially paving the way for new anti-C. difficile therapies."

Journal • Preclinical • Infectious Disease

Concomitant use of direct oral anticoagulants and interacting antiarrhythmic drugs and the risk of stroke and bleeding among patients with non-valvular atrial fibrillation: a multinational cohort study. (PubMed, BMC Med) - "Concomitant use of interacting antiarrhythmic drugs does not seem to affect the effectiveness of DOACs but may increase their risk of major bleeding."

Journal • Atrial Fibrillation • Cardiovascular • Ischemic stroke

Exploratory high-throughput screening of repurposed drugs for canine lymphoid malignancies. (PubMed, BMC Vet Res) - "This exploratory screening study identified clinically approved drugs with available pharmacokinetic data as candidate therapeutic agents for the treatment of canine lymphoid malignancies. Based on this study, further studies are warranted to validate the in vivo efficacy and elucidate the underlying mechanisms of candidate drugs in canine lymphoid malignancies."

Journal • Hematological Malignancies • Lymphoma • Oncology

Dronedarone hydrochloride targets cardiolipin and phosphatidylglycerol to increase colistin susceptibility in gram-negative pathogens. (PubMed, Microbiol Spectr) - "Mechanistic studies revealed that DH bound specifically to CL and PG, thereby enhancing membrane disruption, impairing energy production, and stimulating oxidative stress levels, which collectively augment the bactericidal activity of colistin. These findings present DH as a lead compound for combating colistin resistance, while offering novel mechanistic insights into its role as a colistin potentiator."

Journal • Infectious Disease

Embryotoxicity analysis of anti-arrhythmia drugs amiodarone, dronedarone, and their metabolites using 3D gastruloid models. (PubMed, Reprod Toxicol) - "The study also provided mechanistic and human-relevant insights not attainable through traditional animal testing. Our findings underscore the utility of stem cell-based models for assessing human developmental toxicity, and support their use in evaluating safer alternatives for anti-arrhythmic therapy during pregnancy."

Adverse events • Journal • Cardiovascular • Heart Failure

Comment on Impact of amiodarone on plasma concentration of direct oral anticoagulant in patients with atrial fibrillation. (PubMed, J Formos Med Assoc) - No abstract available

Journal • Atrial Fibrillation • Cardiovascular

Management of arrhythmias in mitral valve prolapse: are we making the right choises for our patients? (ESC-WCC 2025) - "Betablocker was the most commonly used antiarrhythmic medication (137 Holter monitorings [45%] in 64 [54%] patients), followed by flecainide (38 [13%) in 13 [3%] patients), non-dihydropyridine calcium channel blocker (11 [4%] in 4 [3%] patients), sotalol (7 [2%] in 2 [2%] patients) and dronedarone (3 [1%] in 1 [1%] patient). Betablocker was the most commonly used antiarrhythmic medication in MVP patients but showed no reduction in ventricular arrhythmias. Flecainide and sotalol were less frequent used but our study suggested a reduction in ventricular arrhythmias. Randomized control trials are needed to assess the efficacy and safety of different antiarrhythmic medications in MVP."

Clinical • Cardiovascular • Ventricular Tachycardia

Early rhythm control in patients with acute decompensated heart failure (ESC-WCC 2025) - "Rhythm control therapy was defined as cardioversion, use of antiarrhythmic drugs (amiodarone, dronedarone, flecainide, or propafenone) or AF ablation. These hypothesis-generating results support the evaluation of early rhythm control for outcome reduction in patients with AHF and AF."

Clinical • Atrial Fibrillation • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure

Timing of first-time catheter ablation in patients with atrial fibrillation and heart failure - Insights from a Danish nationwide cohort (ESC-WCC 2025) - "AF recurrence was defined as first occurrence of either AF hospitalization, new prescription of anti-arrhythmic drugs (class 1C anti-arrhythmic drugs, dronedarone or amiodarone), electrical cardio-version, or AF re-ablation, with death as competing risk and censoring for emigration. The timing of ablation for patients with AF and HF may impact catheter ablation efficacy. Longer DAT was associated with increased risk of AF recurrence, but there was no significant increased risk of MACE."

Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

Major Bleeding Risk During Concomitant Use of Antiarrhythmic Drugs and Oral Factor Xa Inhibitors: A Nationwide Self-Controlled Case Series Study. (PubMed, Thromb Haemost) - "Concomitant use of FXa inhibitors with amiodarone, diltiazem, or verapamil was related to an increased incidence of major bleeding, particularly during the first month of co-administration. Close monitoring during this period may be warranted for patients at high risk of bleeding."

Journal

First-line catheter ablation for atrial fibrillation - lower than recommended doses of antiarrhythmic drugs may have contributed to their inferiority: Analysis of randomized controlled studies comparing ablation with antiarrhythmic drugs. (PubMed, Trends Cardiovasc Med) - "Among the 442 patients randomized to the drug arm, 15% to 43% received flecainide, propafenone, and sotalol at lower than recommended doses...Notably, up to 10% of the patients in the ablation arm were adjunctively treated with antiarrhythmic drugs. This may have contributed to the reported superiority of catheter ablation compared to antiarrhythmic drug therapy."

Journal • Review • Atrial Fibrillation • Cardiovascular

Safety and efficacy of Dronedarone in people with Metabolic-Associated Fatty Liver Disease:A Phase I/II Exploratory Study (ChiCTR) - P1/2 | N=24 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Army Medical University; The First Affiliated Hospital of Army Medical University

New P1/2 trial • Hepatology

Cost-Effectiveness of Antiarrhythmic Drugs for Treating Paroxysmal or Persistent Atrial Fibrillation in China: An Economic Evaluation. (PubMed, Clin Ther) - "Our analysis suggests that dronedarone is a cost-effective AAD compared to amiodarone and sotalol for patients with paroxysmal or persistent AF in China, offering improvements in life expectancy and QALY in the long-term rhythm control."

HEOR • Journal • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

Management Of Type II Amiodarone-induced Thyrotoxicosis With Low Dose Prednisone And Colestipol, A Bile Acid Binding Resin. (ENDO 2025) - "He was treated with amiodarone 6 months ago, but with onset of thyrotoxicosis, he was switched to dronedarone. Colestipol, a bile acid binding resin has dual mechanism of action in the management of thyrotoxicosis associated with thyroiditis. Bile-salt sequestrants bind thyroid hormones in the intestine and thereby increase their fecal excretion. Studies have also indicated that colestipol significantly reduces the enterohepatic circulation of amiodarone and lowers the serum levels of amiodarone."

Late-breaking abstract • Atrial Fibrillation • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Endocrine Disorders • Heart Failure • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Ophthalmology • Thyroid Eye Disease

Thyroid Function Testing Patterns in Newly Diagnosed Heart Failure (ENDO 2025) - "Main exclusions included receipt of amiodarone, dronedarone, lithium, anti-thyroid, or thyroid replacement medication within 1 year prior to hospitalization and lack of follow-up data through 90 days after discharge. Thyroid testing among patients with new-onset HF was inconsistent in a real-world setting. Testing was more prevalent among patients with HF with reduced ejection fraction, atrial fibrillation, and those receiving guideline directed medical therapy. In-hospital TSH testing resulted in changes in management for a small subset of patients, though the clinical validity and implications of this is uncertain."

Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Endocrine Disorders • Heart Failure

Antiarrhythmic drug use in atrial fibrillation among different European countries - as determined by a physician survey. (PubMed, Int J Cardiol Heart Vasc) - "However, while amiodarone was frequently (88-93 %) used in heart failure with reduced left ventricular ejection fraction, it was also a typical treatment choice for minimal/no-structural heart disease (SHD) (28 %), particularly in UK...Sotalol (16-41 %) and dronedarone use (10-54 %) in CAD varied among countries...Despite recognizing the importance of guidelines, deviations in AAD use were common with the potential to compromise patient safety. These findings indicate the need for more educational support for optimal AAD selection in AF management."

Journal • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure • Renal Disease

Real-World Health Care Resource Utilization and Costs Associated With First-Line Dronedarone Versus First-Line Ablation in Adults With Atrial Fibrillation. (PubMed, Clin Cardiol) - "Over 24-months' follow-up in patients with AF, first-line dronedarone was associated with comparable rates of inpatient/outpatient visits, and lower total payer costs compared with an ablation-based approach."

Clinical • HEOR • Journal • Real-world evidence • Retrospective data • Atrial Fibrillation • Cardiovascular

Cost-Effectiveness of Antiarrhythmic Drugs for Treating Paroxysmal or Persistent Atrial Fibrillation in China (ISPOR 2025) - "Our analysis suggests that dronedarone is a cost-effective AAD compared to amiodarone and sotalol for patients with paroxysmal or persistent AF in China, offering improvements in life expectancy and QALY in the long-term rhythm control."

Cost effectiveness • HEOR • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4. (PubMed, Clin Res Cardiol) - P4 | "Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4."

Journal • Acute Coronary Syndrome • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Coronary Artery Disease • Heart Failure

Determination of Dronedarone and Debutyldronedarone in Human Plasma by HPLC-UV. (PubMed, Int J Mol Sci) - "The adequate specificity, accuracy and precision were demonstrated in accordance with EMA guidelines, i.e., ≤15% (≤20% for the LLOQ), which ensures the reliability of the measurements. This method can be recommended for laboratories with basic HPLC equipment for TDM, adherence assessments and even in PK studies during chronic DRO therapy."

Journal

Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria. (PubMed, Europace) - P3, P4 | "These data support the use of dronedarone for early rhythm control therapy in selected patients with early AF."

Journal • Retrospective data • Acute Coronary Syndrome • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

Towards personalized therapy for atrial fibrillation: the rhythmic climbing of dronedarone. (PubMed, Europace) - No abstract available

Journal • Atrial Fibrillation • Cardiovascular

Dronedarone vs Sotalol Among Patients With Atrial Fibrillation: A Meta-Analysis of Retrospective Observational Databases. (PubMed, JACC Clin Electrophysiol) - "In this retrospective meta-analysis, dronedarone exhibited significantly lower rates of CV hospitalization and ventricular arrhythmias compared with sotalol. These findings provide real-world evidence to support selection of the most appropriate first-line AAD for rhythm control in patients with AF."

Journal • Observational data • Retrospective data • Atrial Fibrillation • Cardiovascular