Dronedarone In Atrial Fibrillation Research Articles

Efficacy of Shensong Yangxin capsule combined with dronedarone in paroxysmal atrial fibrillation after ablation.

To investigate whether postoperative administration of Shensong Yangxin capsules (SSYX) and dronedarone for atrial fibrillation (AF) can reduce the recurrence of paroxysmal AF after radiofrequency ablation, thus providing a more optimal choice of antiarrhythmic medication during the blank period. We included 120 patients with paroxysmal AF who underwent radiofrequency ablation at our hospital between July 2020 and July 2022. They underwent routine circumferential pulmonary vein ablation and, subsequently, left and right atrial pressure monitoring to assess sinoatrial node recovery time under burst 400/300 ms stimulation. Postoperatively, the patients were randomly divided into 2 groups (60 patients each). The control group was administered dronedarone orally for 3 months and the study group was treated with SSYX combined with dronedarone. This study aimed to compare differences in clinical efficacy of the treatment between the 2 groups. The left and right atrial pressures in both groups were higher than those in the preoperative period (P < .05), with no statistically significant differences between the 2 groups (P > .05). Sinoatrial node recovery time under burst 400/300 ms stimulation showed no statistical difference between the 2 groups (P > .05). At 3 months and 1 year postoperatively, the AFEQT scale scores for both groups were lower than those before treatment (P < .05), with the study group scoring lower than the control group at 3 months (P < .05). However, no statistically significant difference was observed between the 2 groups at 1 year postoperatively (P > .05). At 3 months postoperatively, the sinus rhythm maintenance rate and heart rate were higher in the intervention group than in the control group (P < .05); however, these differences between the 2 groups were not statistically significant at 1 year postoperatively (P > .05). The combination of SSYX and dronedarone could effectively reduce the early recurrence of paroxysmal AF after radiofrequency ablation, increase heart rate, and improve the quality of life.

Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies

AimThis post hoc analysis evaluated efficacy and safety of dronedarone in atrial fibrillation (AF) and atrial flutter (AFL) patients with/without diabetes. MethodsPatients were categorized according to baseline diabetes status. Time-to-event analyses were performed using Kaplan-Meier method. Hazard-ratios were assessed using Cox models. Results945/4628 (dronedarone = 482; placebo = 463) patients in ATHENA and 215/1237 (dronedarone = 148; placebo = 67) patients in EURIDIS/ADONIS studies had diabetes. In ATHENA, there were higher rates of CV hospitalization/death in patients with diabetes (39.5%) than without diabetes (34.7%). Incidence of first CV hospitalization/death was lower in patients with diabetes treated with dronedarone (35.1%) than placebo (44.1%), and time to this event was longer in those treated with dronedarone than placebo (log-rank p = 0.005). Median AF/AFL recurrence time was longer in patients treated with dronedarone than placebo in patients with diabetes (ATHENA: 722 vs 527 days, log-rank p = 0.004; EURIDIS/ADONIS: 100 vs 23 days, log-rank p = 0.15) or without diabetes (ATHENA: 741 vs 492 days, log-rank p < 0.0001; EURIDIS/ADONIS: 120 vs 59 days, log-rank p = 0.0002). Occurrence of any treatment-related adverse events with dronedarone was similar for patients with/without diabetes and was comparable to placebo. ConclusionsDronedarone reduced incidence of CV hospitalization/death, AF/AFL recurrence and increased time to these events in AF/AFL patients with/without diabetes. Trial registrationNot applicable, as it was a post hoc analysis. This article is based on previously conducted studies (ATHENA: NCT00174785, EURIDIS: NCT00259428, and ADONIS: NCT00259376).

Outcomes with Dronedarone in Atrial Fibrillation: What Differences Between Real-World Practice and Trials? A Meta-Analysis and Meta-Regression Analysis.

Dronedarone was found to have divergent safety profiles in randomized controlled trials (RCT) in term of cardiac death and overall mortality. We decided to evaluate all available evidence on the cardiovascular safety of this drug. A systematic search was made of the MEDLINE and the Cochrane Central Register of Controlled Trials from January 2003 through April 2016 for RCT comparing dronedarone to placebo/active control, to provide the most accurate estimate of the effects of this agent and observational cohort studies (OBS) reporting clinical outcomes in patients treated with dronedarone, according to current guidelines, to obtain a real-life comparator for the findings summarized by RTC analysis. The literature search yielded 2335 papers and after careful review we identified 12 RCT and 7 OBS studies. RCT meta-analysis showed that, despite high heterogeneity, dronedarone was not associated with increased all-cause mortality [OR (Odds Ratio) 1.36, 95%CI (Confidence Interval) 0.79-2.33; p=0.732, I2=57.0%] or cardiovascular mortality [OR 1.51 95%CI 0.74-3.08; p=0.860, I2=64.4%]. OBS studies had a trend toward a better survival with respect to RCT [ES (Effect Size) 2.03, 95%CI 0.53-3.53 vs. ES 3.03, 95%CI 1.23-4.83; p=0.115], reaching the significance when restricted to the cardiovascular mortality [ES 0.52, 95%CI 0.36-0.69 vs. ES 1.86, 95%CI 0.62-3.09; p<0.001]. Two variables, co-adiministration of digoxin and prevalence of non-permanent AF completely abolished the dishomogeneity among the analyzed RCT studies. In conclusion, use of dronedarone for prophylaxis of AF recurrences is not associated with an increased risk of death, either cardiovascular or total, and combination with digoxin should be avoided.

A placebo-controlled, double-blind, randomized, multicenter study to assess the effects of dronedarone 400 mg twice daily for 12 weeks on atrial fibrillation burden in subjects with permanent pacemakers.

PurposeDronedarone is a benzofuran derivative with a pharmacological profile similar to amiodarone but has a more rapid onset of action and a much shorter half-life (13–19 h). Our goal was to evaluate the efficacy of dronedarone in atrial fibrillation (AF) patients using dual-chamber pacemakers capable of quantifying atrial fibrillation burden.MethodsPacemakers were adjusted to optimize AF detection. Patients with AF burden >1 % were randomized to dronedarone 400 mg twice daily (BID) or placebo. Pacemakers were interrogated after 4 and 12 weeks of treatment. The primary endpoint was the change in AF burden from baseline over the 12-week treatment period. Patients with permanent AF, severe/recently decompensated heart failure, and current use of antiarrhythmic drugs were excluded. AF burden was assessed by a core laboratory blinded to treatment assignment.ResultsFrom 285 patients screened, 112 were randomized (mean age 76 years, 60 % male, 84 % hypertensive, 65 % with sick sinus syndrome, 26 % with diabetes mellitus type II, 15 % with heart failure). Baseline mean (SEM) AF burden was 8.77 % (0.16) for placebo and 10.14 % (0.17) for dronedarone. Over the 12-week study period, AF burden compared to baseline decreased by 54.4 % (0.22) (P = 0.0009) with dronedarone and trended higher by 12.8 % (0.16) (P = 0.450) with placebo. The absolute change in burden was decreased by 5.5 % in the dronedarone group and increased by 1.1 % in the placebo group. Heart rate during AF was reduced to approximately 4 beats/min with dronedarone (P = 0.285). Adverse events were higher with dronedarone compared to placebo (65 vs 56 %).ConclusionsDronedarone reduced pacemaker-assessed the relative AF burden compared to baseline and placebo by over 50 % during the 12-week observation period.

Efficacy and safety of dronedarone in patients previously treated with other antiarrhythmic agents.

Currently available antiarrhythmic drugs (AADs) for the prevention of atrial fibrillation (AF)/atrial flutter (AFL) suffer from incomplete efficacy and poor tolerability. Dronedarone could represent an effective and safe option in patients previously treated with AADs, especially class Ic AADs and sotalol. Retrospective analysis of 2 double-blind, parallel-group trials (EURIDIS [European Trial in Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm] and ADONIS [American-Australian-African Trial With Dronedarone in Atrial Fibrillation or Flutter Patients for the Maintenance of Sinus Rhythm]) comparing the efficacy and safety of dronedarone with placebo over 12 months. The primary end point was AF/AFL recurrence in patients previously treated with another AAD that was discontinued for whatever reason prior to randomization. In patients previously treated with any AADs, dronedarone decreased the risk of AF recurrence by 30.4% vs placebo (hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.59-0.82; P < 0.001). In patients previously treated with a class Ic agent, dronedarone decreased the risk of recurrence by 31.4% (HR: 0.69; 95% CI: 0.53-0.89; P = 0.004), whereas in patients previously treated with sotalol, dronedarone showed a trend toward a decrease of risk of recurrence (HR: 0.86; 95% CI: 0.67-1.11; P = 0.244). Dronedarone was equally effective irrespective of whether class Ic or sotalol were stopped for lack of efficacy or adverse events (AEs). Discontinuation rates were similar in the 2 groups (55.9% vs 43.1%), as were incidence of AEs and serious AEs. Dronedarone seems to be effective in preventing AF recurrences in patients without permanent AF previously treated with other AADs, even if those were discontinued for lack of efficacy. Dronedarone appears to be well tolerated even in patients who already had tolerability issues with AADs.

Efficacy and tolerability of dronedarone for patients with atrial fibrillation

Dronedarone is a new antiarrhythmic drug used in the treatment of atrial fibrillation (AF). We investigate its efficacy and tolerability in clinical practice. We identified 208 patients treated with dronedarone for AF at the Northwestern outpatient practice. Charts were reviewed for clinical efficacy and reasons for discontinuation of the drug. The average age was 65.2 ± 10.8 years, 37% females. Paroxysmal, persistent andpermanent AF were noted in 46.2%, 51.9%, and 1.9%, respectively. Average ejection fraction was 56.3 ± 9.1%, 12.8% had a history of congestive heart failure, and 10.3% had valvularheart disease. Dronedarone was discontinued in 25 patients after curative catheter or surgical ablation procedure. Of the remaining 183 patients, dronedarone was discontinued in 48.6% after a mean duration of 6.2 ± 6.3 months because of in efficacy (26.2%), side effects (6%), and other reasons (16.4%). For those remaining on dronedarone (n = 94), after a mean of 11.6 ± 6.6 months, clinical efficacy (resolution of or patient-reported improvement in symptoms) was noted in 45.4% patients. On dronedarone therapy, 57.4% had no AF on follow-up (overallefficacy of 29.5%). To evaluate efficacy, ECG only or long-term monitoring were performed in 62.7% and 37.3%, respectively, and found no AF in 69.2 and 48.4%, respectively. There were 3 deaths and 2 transient ischemic attacks (TIA) off dronedarone vs. 1 death, 1 TIA and 2 strokes on dronedarone. Dronedarone has a significant discontinuation rate due to both inefficacy and side effects in clinical practice. Nevertheless, it has moderate clinical efficacy and tolerability in an outpatient population of patients with AF.

Elevated liver enzymes associated with dronedarone for atrial fibrillation.

A 51-year-old male with documented atrial fibrillation who was taking dronedarone 400 mg twice daily for approximately 3 months returned to the cardiologist for an ablation procedure. Baseline liver enzymes were within normal range prior to starting the medication and increased after the 3 months of therapy. Aspartate aminotransferase increased from 31 IU/L to 98 IU/L, and alanine aminotransferase increased from 21 IU/L to 101 IU/L. Two and a half months after discontinuation of the medication, liver enzymes normalized (aspartate aminotransferase: 30 IU/L and alanine aminotransferase: 25 IU/L). The Food and Drug Administration has now alerted health-care professionals of the potential for liver injury based upon post-marketing surveillance. The chronological course of elevated liver enzymes noted in our patient is suggestive of a dronedarone-induced problem. Clinicians should have a heightened awareness of the potential for liver enzyme elevation and injury with dronedarone and should monitor enzymes periodically, especially within the first 6 months of use.

Dronedarone in atrial fibrillation: the aftermath of the PALLAS trial

Dronedarone is a new antiarrhythmic currently approved for use among patients with nonpermanent atrial fibrillation (AF) based on the positive results of the ATHENA trial. Dronedarone was recently investigated in the PALLAS (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy) trial, a landmark trial that evaluated treatment with dronedarone compared with placebo among older patients with permanent AF. The trial was terminated early due to a significant increase in adverse cardiovascular events among dronedarone-treated patients. In this article, the trial is presented and the significance and practical implications of the results in the management of older patients with AF briefly discussed.

Drug safety evaluation of dronedarone in atrial fibrillation

Introduction:Dronedarone was developed with the intent of replicating the antiarrhythmic effects of amiodarone, while minimizing its side effects.Areas covered:Side effects reported in eight randomized clinical trials are discussed, comparing dronedarone and placebo (DAFNE, EURIDIS, ADONIS, ERATO, ANDROMEDA, ATHENA, PALLAS, total number of patients treated with dronedarone 5347), or dronedarone and amiodarone (DIONYSOS, total number of patients treated with dronedarone 249).Expert opinion:The results of the first trials, including ATHENA, set high expectations by suggesting that dronedarone may decrease the risk of hospitalization (and even cardiovascular mortality) among patients with paroxysmal and persistent atrial fibrillation (AF), and that it could be regarded as an easy-to-use drug that could be prescribed by general practitioners; unfortunately, dronedarone has not met these expectations. Dronedarone may increase mortality and heart failure hospitalization in patients with advanced NYHA class and in patients with permanent AF, preventing its use in these settings. In addition to gastrointestinal side effects that may lead to discontinuation in 5 – 10% of patients, dronedarone may induce very rare but severe liver and lung toxicity. Despite these limitations and its relatively limited antiarrhythmic potency, dronedarone may still be a useful drug for well-selected patients.

Novel electrophysiological properties of dronedarone: inhibition of human cardiac two-pore-domain potassium (K2P) channels

Dronedarone is currently used for the treatment of paroxysmal and persistent atrial fibrillation (AF). Pharmacological inhibition of cardiac two-pore-domain potassium (K(2P)) channels results in action potential prolongation and has recently been proposed as novel antiarrhythmic strategy. We hypothesized that blockade of human K(2P) channels contributes to the electrophysiological efficacy of dronedarone in AF. Two-electrode voltage clamp and whole-cell patch clamp electrophysiology was used to record K(2P) currents from Xenopus oocytes and Chinese hamster ovary cells. All functional human K(2P) channels were screened for dronedarone sensitivity, revealing significant and concentration-dependent inhibition of cardiac K(2P)2.1 (TREK1; IC(50) = 26.7μM) and K(2P)3.1 channels (TASK1; IC(50) = 18.7μM) with maximum current reduction of 60.3 and 65.5% in oocytes. IC(50) values obtained from mammalian cells yielded 6.1μM (K(2P)2.1) and 5.2μM (K(2P)3.1). The molecular mechanism of action was studied in detail. Dronedarone block affected open and closed channels. K(2P)3.1 currents were reduced in frequency-dependent fashion in contrast to K(2P)2.1. Mutagenesis studies revealed that amino acid residues implicated in K(2P)3.1 drug interactions were not required for dronedarone blockade. The class III antiarrhythmic drug dronedarone targets multiple human cardiac two-pore-domain potassium channels, including atrial-selective K(2P)3.1 currents. K(2P) current inhibition by dronedarone represents a previously unrecognized mechanism of action that extends the multichannel blocking profile of the drug.

Cost-Effectiveness of Dronedarone in Atrial Fibrillation: Results for Canada, Italy, Sweden, and Switzerland

BackgroundDronedarone is a therapy for the treatment of patients with paroxysmal and persistent atrial fibrillation or atrial flutter. According to results in the ATHENA trial, dronedarone on top of standard of care (SOC) decreases the risk of cardiovascular hospitalizations or death by 24% compared with SOC alone. ObjectivesA patient-level health economic model was developed to evaluate the cost-effectiveness of dronedarone on top of SOC versus SOC alone. MethodsThe risk of experiencing stroke, congestive heart failure, acute coronary syndromes, treatment discontinuation, and death was modeled by separate health states, whereas adverse events were included as 1-time cost and utility decrements. State transition probabilities were primarily deduced from the patient-level data from ATHENA using survival analysis. Four sets of analyses were performed to reflect costs and treatment effects in Canada, Italy, Sweden, and Switzerland. Cost-effectiveness analysis was also conducted in a newly defined patient population identified by the European Medicines Agency (EMA) to avoid the use of dronedarone in permanent AF patients resembling those in the PALLAS study. ResultsThe predicted survival time was, for the Canadian cohort, extended from 10.11 to 10.24 years when dronedarone was added to SOC. Similar results were found for the other countries, resulting in incremental cost-effectiveness ratios (ICERs) of €5828, €5873, €14,970, and €8554 per QALYs for Canada, Italy, Sweden, and, Switzerland, respectively. These results are all well below current established cost-effectiveness thresholds. In the EMA-restricted population, all patients were predicted to live longer, and the ICER increased but remained within established thresholds, with an average cost per QALY gained of €15,900. ConclusionsDronedarone on top of SOC appears to be a cost-effective treatment for atrial fibrillation compared with SOC alone. Despite the differences in the local settings considered, the results were consistent among all the countries included in the study. ClinicalTrials.gov identifier: NCT00174785.

Dronedarone for the Treatment of Atrial Fibrillation

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dronedarone (Multaq®, Sanofi-Aventis Limited, UK) to submit evidence on the clinical and cost effectiveness of the anti-arrhythmic drug (AAD) for the treatment of atrial fibrillation (AF) and atrial flutter, as part of the Institute's single technology appraisal (STA) process. The Centre for Reviews and Dissemination and the Centre for Health Economics, both at the University of York, were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and NICE's subsequent decisions regarding the use of dronedarone within the UK NHS. The ERG review comprised a critique of the submitted evidence on the clinical effectiveness and cost effectiveness of dronedarone. The ERG examined the search strategy used to obtain relevant evidence, the selection of studies included in the assessment, outcome measures chosen and statistical methods employed. The ERG also validated the manufacturer's decision analytic model and used it to explore the robustness of the cost-effectiveness results to key assumptions. The main clinical effectiveness evidence supporting the use of dronedarone as a treatment for AF came from four randomized controlled trials. These trials were compared with a broader set of trials examining the effectiveness of other AADs for AF: amiodarone, sotalol and class 1c agents (flecainide and propafenone). The evidence suggested that all AADs decreased the recurrence of AF but dronedarone had the smallest effect. A mixed treatment comparison analysis of the trials showed that dronedarone was associated with a lower risk of all-cause mortality than other AADs, but this was highly uncertain. There was limited evidence to assess the effect of dronedarone on stroke, and no statistically significant differences between dronedarone and other AADs were found for treatment discontinuation. From the evidence presented by the manufacturer, dronedarone appeared highly cost effective in each of the population groups examined compared with using standard baseline therapy alone as first-line treatment, or compared with sotalol or amiodarone as first-line AAD, with incremental cost-effectiveness ratios (ICERs) well below £20,000 per QALY gained. The ICER for dronedarone relative to class 1c agents was around £19,000 per QALY. Although the evidence presented by the manufacturer indicated that dronedarone was cost effective, the estimates of treatment effect relative to other AADs and safety in the longer term were highly uncertain. The NICE Appraisal Committee in its preliminary guidance did not recommend the use of dronedarone for AF. However, following the response from a large number of consultees and commentators, NICE revised its preliminary guidance to allow the use of the drug in a specific subgroup of AF patients with additional cardiovascular risk factors.

Acute Liver Failure Associated With Dronedarone

A 70-year-old woman was initially referred to a community hospital for progressive fatigue and hyperbilirubinemia for 2 weeks. Six months before admission, she was started on dronedarone for atrial fibrillation. The latest liver function tests had been within normal range 9 months before admission. Her medical history included coronary artery disease and chronic obstructive pulmonary disease. She had no allergies. She did not smoke, drink alcohol, or use illicit drugs. Her current medication included aspirin, bisoprolol, dronedarone, lisinopril, hydrochlorothiazide, amlodipine, formoterol, ipratropium bromide, and simvastatin. Over the course of her hospital stay, her total bilirubin peaked at 30.3 mg/dL, she had development of coagulopathy refractory to therapy (precluding liver biopsy), and serial ultrasound Doppler …

Dronedarone for atrial fibrillation: How does it compare with amiodarone?

Dronedarone (Multaq), an analogue of amiodarone (Cordarone), was designed to cause fewer adverse effects than the parent compound. Studies have indeed shown dronedarone to be safer than amiodarone, but less effective. Its official indication is to reduce the risk of hospitalization in patients with paroxysmal or persistent atrial fibrillation or atrial flutter and other cardiovascular risk factors, reflecting the parameters of its effectiveness in clinical trials.

Role of Dronedarone in Atrial Fibrillation: More Questions Than Answers

Role of Dronedarone in Atrial Fibrillation: More Questions Than Answers

Impact of dronedarone in atrial fibrillation and flutter on stroke reduction

Dronedarone has been developed for treatment of atrial fibrillation (AF) or atrial flutter (AFL). It is an amiodarone analogue but noniodinized and without the same adverse effects as amiodarone. This is a review of 7 studies (DAFNE, ADONIS, EURIDIS, ATHENA, ANDROMEDA, ERATO and DIONYSOS) on dronedarone focusing on efficacy, safety and prevention of stroke. There was a dose-finding study (DAFNE), 3 studies focusing on maintenance of sinus rhythm (ADONIS, EURIDIS and DIONYSOS), 1 study focusing on rate control (ERATO) and 2 studies investigating mortality and morbidity (ANDROMEDA and ATHENA). The target dose for dronedarone was established in the DAFNE study to be 400 mg twice daily. Both EURIDIS and ADONIS studies demonstrated that dronedarone was superior to placebo for maintaining sinus rhythm. However, DIONYSOS found that dronedarone is less efficient at maintaining sinus rhythm than amiodarone. ERATO concluded that dronedarone reduces ventricular rate in patients with chronic AF. The ANDROMEDA study in patients with severe heart failure was discontinued because of increased mortality in dronedarone group. Dronedarone reduced cardiovascular hospitalizations and mortality in patients with AF or AFL in the ATHENA trial. Secondly, according to a post hoc analysis a significant reduction in stroke was observed (annual rate 1.2% on dronedarone vs 1.8% on placebo, respectively [hazard ratio 0.66, confidence interval 0.46 to 0.96, P = 0.027]). In total, 54 cases of stroke occurred in 3439 patients (crude rate 1.6%) receiving dronedarone compared to 76 strokes in 3048 patients on placebo (crude rate 2.5%), respectively. Dronedarone can be used for maintenance of sinus rhythm and can reduce stroke in patients with AF who receive usual care, which includes antithrombotic therapy and heart rate control.

Dronedarone for atrial fibrillation: a new therapeutic agent

Atrial fibrillation is the most common of the serious cardiac rhythm disturbances and is responsible for substantial morbidity and mortality. Amiodarone is currently one of the most widely used and most effective antiarrhythmic agents for atrial fibrillation. But during chronic usage amiodarone can cause some serious extra cardiac adverse effects, including effects on the thyroid. Dronedarone is a newer therapeutic agent with a structural resemblance to amiodarone, with two molecular changes, and with a better side effect profile. Dronedarone is a multichannel blocker and, like amiodarone, possesses both a rhythm and a rate control property in atrial fibrillation. The US Food and Drug Administration approved dronedarone for atrial fibrillation on July 2, 2009. In this review, we discuss the role of dronedarone in atrial fibrillation.

Dronedarone

Dronedarone, a potassium channel antagonist, is chemically related to amio-darone. It is being developed by sanofi-aventis as a class III antiarrhythmic agent for the treatment of atrial fibrillation and atrial flutter in the US and Europe. Dronedarone has a favourable benefit/risk ratio, with the absence of any proarrhythmic effects. Sanofi merged with Synthélabo to form Sanofi-Synthélabo in 1999. In August 2004, Sanofi-Synthelabo merged with Aventis to form sanofi-aventis. The ATHENA trial is a multinational, randomised, double-blind trial evaluating the effects of dronedarone (400mg bid) compared with placebo, over a minimum 12-month follow-up period, in patients with atrial fibrillation or flutter. The trial is investigating the efficacy of dronedarone in preventing cardiovascular hospitalisations or death from any cause. Enrolment was extended to 4300 patients in order to attain the planned rate of adverse events; patient recruitment is ongoing.Previously, sanofi-aventis completed two pivotal phase III trials in atrial fibrillation. The trials, EURIDIS (EURopean trial In atrial fibrillation or flutter patients for the maintenance of Sinus rhythm) and ADONIS (American-Australasian trial with DronedarONe In atrial fibrillation or flutter patients for the maintenance of Sinus rhythm), involved 1237 patients who were in sinus rhythm at the time of randomisation. Results showed dronedarone to have anti-arrhythmic effects and a favourable benefit/risk ratio, with the absence of any proarrhythmic effect.Another trial, ERATO (Efficacy and safety of dronedARone for The cOntrol of ventricular rate), took place in 35 centres across nine European countries assessing dronedarone in 174 patients with permanent atrial fibrillation. Dronedarone was in phase II trials in Japan for the treatment of atrial fibrillation; however, no recent developments have been reported.