Open AccessEfficacy and Safety of Dronedarone in Patients Previously Treated With Other Antiarrhythmic Agents
Author(s) -
Guerra Federico,
Hohnloser Stefan H.,
Kowey Peter R.,
Crijns Harry J. G. M.,
Aliot Etienne M.,
Radzik David,
Roy Denis,
Connolly Stuart,
Capucci Alessandro
Publication year - 2014
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.22342
Subject(s) - dronedarone , medicine , sotalol , atrial flutter , atrial fibrillation , cardiology , discontinuation , hazard ratio , sinus rhythm , placebo , amiodarone , antiarrhythmic agent , anesthesia , confidence interval , heart disease , alternative medicine , pathology
Background Currently available antiarrhythmic drugs ( AADs ) for the prevention of atrial fibrillation ( AF )/atrial flutter ( AFL ) suffer from incomplete efficacy and poor tolerability. Hypothesis Dronedarone could represent an effective and safe option in patients previously treated with AADs , especially class Ic AADs and sotalol. Methods 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. Results 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 . Conclusions 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 .