| atrial fibrillation | versus placebo or control No demonstrated result for efficacy dronedarone inferior to placebo in terms of Withdrawals due to adverse effects in ATHENA, 2009 dronedarone inferior to placebo in terms of Stroke in PALLAS, 2011 dronedarone inferior to placebo in terms of HF hospitalization
in PALLAS, 2011 dronedarone inferior to placebo in terms of Cardiovascular events in PALLAS, 2011 dronedarone inferior to placebo in terms of Death, unplanned CV hospitalization in PALLAS, 2011 | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EURIDIS, 2007 | dronedarone vs placebo | Atrial fibrillation recurrence 0.78 [0.64; 0.95] Death, unplanned CV hospitalization 0.66 [0.47; 0.93] | | | | ADONIS, 2007 | dronedarone vs placebo | Atrial fibrillation recurrence 0.73 [0.60; 0.89] | | Death, unplanned CV hospitalization 0.80 [0.56; 1.14] | | DAFNE, 2003 | dronedarone vs placebo | Atrial fibrillation recurrence 0.86 [0.75; 0.98] | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects ∞ [NaN; ∞] Pro-arrhythmia NaN [NaN; NaN] | | EURIDIS ADONIS (pooled analysis), 2009 | dronedarone vs placebo | | | all cause mortality 1.32 [0.35; 4.94] Stroke 1.98 [0.22; 17.62] Withdrawals due to adverse effects 1.36 [0.91; 2.05] | | ATHENA, 2009 | dronedarone vs placebo | cardiovascular death 0.71 [0.52; 0.97] Cardiovascular events 0.81 [0.75; 0.88] Cardiac arrhythmic death 0.55 [0.34; 0.88] hospitalization for AF 0.66 [0.59; 0.75] Atrial fibrillation recurrence 0.66 [0.59; 0.75] Death, unplanned CV hospitalization 0.81 [0.75; 0.88] | Withdrawals due to adverse effects 1.57 [1.32; 1.87] | all cause mortality 0.84 [0.66; 1.07] HF hospitalization
0.86 [0.67; 1.10] non CV death 1.09 [0.74; 1.61] Vascular noncardiac death 0.84 [0.47; 1.52] Cardiac nonarrhythmic death 0.96 [0.49; 1.85] | | ERATO, 2008 | dronedarone vs placebo | | | all cause mortality ∞ [NaN; ∞] Withdrawals due to adverse effects 1.51 [0.68; 3.35] | | PALLAS, 2011 | dronedarone vs placebo | | Stroke 2.42 [1.01; 5.82] HF hospitalization
2.26 [1.24; 4.13] Cardiovascular events 2.28 [1.22; 4.25] Death, unplanned CV hospitalization 1.45 [1.10; 1.91] | all cause mortality 2.28 [0.94; 5.52] MI 1.00 [0.20; 4.93] |
| Trial | Treatments | Patients | Method |
|---|
| EURIDIS, 2007 | dronedarone 400 mg twice daily
(n=411) vs. placebo
(n=201)
| patients with at least one episode of atrial fibrillation in the preceding 3 months, and in sinus rhythm for at least 1 hour before randomization
| double blind Parallel groups Sample size: 411/201 Primary endpoint: recurrence of atrial fibrillation FU duration: 12 months
| | ADONIS, 2007 | dronedarone 400 mg twice daily (n=417) vs. placebo (n=208) | patients with at least one episode of atrial fibrillation in the preceding 3 months, and in sinus rhythm for at least 1 hour before randomization | double blind Parallel groups Sample size: 417/208 Primary endpoint: recurrence of atrial fibrillation FU duration: 12 months | | DAFNE, 2003 | Dronedarone various doses (800, 1200, 1600 mg/d) (n=151) vs. placebo (n=48) | patients with Persistent AF | double blind Parallel groups Sample size: 151/48 Primary endpoint: FU duration: | | EURIDIS ADONIS (pooled analysis), 2009 | Dronedarone 800 mg/d (n=828) vs. placebo (n=409) | AF documented in the previous 3 months | double blind Parallel groups Sample size: 828/409 Primary endpoint: First Recurrence of Atrial Fibrillation or flutter FU duration: 12 months | | ATHENA, 2009 | dronedarone 400 mg twice a day (n=2301) vs. placebo (n=2327) | patients (>70y)
with paroxysmal or persistent atrial fibrillation and additional risk factors for death | double blind Parallel groups Sample size: 2301/2327 Primary endpoint: first hospitalization due to cardiovascular events or death FU duration: 21.5 months | | ERATO, 2008 | dronedarone 400 mg twice daily (n=85) vs. placebo (n=89) | patients with permanent AF | double blind Parallel groups Sample size: 85/89 Primary endpoint: ventricular rate FU duration: 6 months | | PALLAS, 2011 | Dronedarone (n=1577) vs. placebo (n=1572) | patients with permanent atrial fibrillation and additional risk factors | double-blind Parallel groups Sample size: 1577/1572 Primary endpoint: major cardiovascular events FU duration: 3 years |
|
| atrial fibrillation | versus amiodarone No demonstrated result for efficacy dronedarone inferior to amiodarone in terms of Atrial fibrillation recurrence in DIONISOS, 2007 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| DIONISOS, 2007 | dronedarone vs amiodarone | Withdrawals due to adverse effects 0.48 [0.25; 0.90] | Atrial fibrillation recurrence 1.34 [1.17; 1.53] | all cause mortality 0.41 [0.08; 2.09] |
| Trial | Treatments | Patients | Method |
|---|
| DIONISOS, 2007 | Dronedarone (400mg BID) (n=249) vs. Amiodarone (600mg daily for 28 days, then 200mg daily thereafter) (n=255) | Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation | double blind Parallel groups Sample size: 249/255 Primary endpoint: treatment failure FU duration: 6 months |
|
| heart failure | versus placebo or control No demonstrated result for efficacy dronedarone inferior to placebo in terms of All cause death in ANDROMEDA, 2008 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ANDROMEDA, 2008 | dronedarone vs placebo | | All cause death 2.13 [1.09; 4.16] | death from any cause or hospitalization 1.35 [0.93; 1.98] Arrhythmic/sudden death 1.70 [0.63; 4.63] |
| Trial | Treatments | Patients | Method |
|---|
| ANDROMEDA, 2008 | dronedarone 400mg twice daily (n=310) vs. placebo (n=317) | patients hospitalized with symptomatic heart failure and severe left ventricular systolic dysfunction | double blind Parallel groups Sample size: 310/317 Primary endpoint: death, hospitalization for HF FU duration: median 2 months |
|
