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- 1. Dronedarone for Maintenance of Sinus Rhythm in Atrial Fibrillation or Flutter Singh, B, MD; Connolly, S, MD; Crijns, H, MD; Roy, D, MD; Kowey, P, MD; Capucci, A., MD; Radzig, D., MD; Aliot, E, MD for the Euridis and Adonis Investigators. NEJM, September 6, 2007 Linda Nabha, MD October 23, 2007
- 16. Baseline Characteristics European Placebo Dronedarone Non-European Placebo Dronedarone Combined Placebo Dronedarone Age (yr) 61.3 62.3 63 64.6 62.2 63.5 Sex (%F) 30.3 30.7 32.7 29.7 31.5 30.2 Structural HD 33.3 36.3 45.6 48.5 39.7 42.4 LVEF % 59.83 + 9.37 59.6 + 10 57.1 + 12.2 57.9 + 11.2 58.5 + 11 58.6 + 1.8 Recent cardio-version* % 37.3 37.2 22.1 21.6 29.6 29.3
- 18. Results
- 20. Results
- 21. Adverse Events VARIABLE DRONEDARONE N=828 PLACEBO N=409 P value Stroke 4 (0.5) 3 (0.7) 0.69 Cough Dyspnea 19 (2.3) 7(1.7) 0.67 Hyperthyroidism Hypothyroidism 67/801 (8.4) 44/801 (5.5 56/396 (14.1) 14/396 (3.5) 0.002 0.15 Abnormal LFTs 100/822 (12.2) 55/404(13.6) 0.52 Elev of Serum Creatinine 20 (2.4) 1 (0.2) 0.004 Bradycardia Heart Failure 22 (2.7) 20 (2.4) 8 (2.2) 4 (1.0) 0.56 0.12
- 25. QUESTIONS?
Editor's Notes
- Approximately 2.5 million Americans, or close to 1% of the total population, currently have atrial fibrillation lack of coordinated atrial contraction leads to unusual fluid flow states through the atrium that are permissive for formation of thrombus that is then at risk to embolize
- There are two standard approaches to converting AF to sinus rhythm: synchronized external DC cardioversion and pharmacologic cardioversion. Anticoagulation should be achieved with adjusted-dose warfarin unless the patient is considered at low embolic risk or has a contraindication.
- Amiodarone has multiple effects on myocardial depolarization and repolarization that make it an extremely effective antiarrhythmic drug. pulmonary toxicity usually occurs several months to as late as several years after the initiation Thyroid dysfunction (including both hypothyroidism and hyperthyroidism
- The iodine moiety has been thought involved in amiodarone 's pulmonary toxicity, hepatitis, thyroid side effects, and eye disturbances. Thus, dronedarone may have fewer of the long-term complications associated with amiodarone. In the ANDROMEDA trial, pt were high risk pt with severe CHF and ventricular dysfunction
- Interesting to note here, sinus rhythm was achieved in these participants in multiple ways: Including cardioversion up to one hour prior to randomization and Previous treatment of with amiodaone was permitted and pt who had received the drug could be enrolled immediately after its discontinuation.
- Class I includes:Digoxin, quinidine Class III includes
- The hypothesis for determining the number of pt needed for the study was based on efficacy trials comparing amiodarone to placebo and the presumption that 60% of pt in the placebo group would have a recurrence of an arrythmia and those in the dronedarone group would a a decreased in this rate of at least 25%
- Each trial would have a power of 90% to detect a between group difference .
- This was defined as an episode lasting for at least 10 minutes and confirmed by 2 consecutive recordings taken 10 min apart on a 12 lead EKG or transtelephonic monitoring. Symptoms included dyspnea, chest pain, fatigue, dizziness
- With all randomized patients who received at least one dose of a study drug included
- Recent cardioversion included within last 5 days of randomization
- This information is seen in chart form: On the verticle axis is the variables Horizontally are the trials. Median Days to recurrence Recurrence rate at 12 months
- Again on verticle axis are the variables On the horizontal axis is the trials
- This is a modified chart of the adverse side effects and lab values. Singh et al excluded pt who inconsistent changes in measeures of thyroid function. Pt with no abnormalityh and with at least one missing measurement of liver function were exluded
- 1. Since the study didn’t directly compare the drugs there is no certainty that dronedarone is as efficacious as amiodarone or that the adverse events is lower. 2. The majority of AF in general fibrillation may be symptomatic. It is likely they were not able to detect all or the first episode of Afib in a patient Since the primary endpoint was to detect the occurrence of the endpoint. 3. One of the major side effects of amio is the pulmonary toxicity which occurs years into taking amio. Most patients did not have CXR done during the study unless pt had pulmonary symptoms.