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An individual patient-based meta-analysis of the effects of dronedarone in patients with atrial fibrillation
- Source :
- Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 16(8)
- Publication Year :
- 2014
-
Abstract
- Aims Dronedarone is a non-iodinated benzofuran derivative with antiarrhythmic properties. In placebo-controlled atrial fibrillation (AF) trials, the drug was found to have divergent effects on endpoints such as cardiovascular death or hospitalization. The objective of this meta-analysis of all placebo-controlled studies was to provide insights on possible reasons for these divergent effects. Methods and results Individual data on 9664 patients were used from all AF placebo-controlled studies. The primary outcome measure was cardiovascular death. Cardiovascular hospitalization and hospitalization for heart failure were secondary endpoints. Predefined procedures were used to reduce inter-study heterogeneity adjusting for important baseline variables using a Cox model. Despite adjustments, a significant inter-trial heterogeneity of the outcome of cardiovascular mortality persisted ( P -value of 0.005 for the treatment effect × study interaction). Further analyses were conducted in subgroups based on baseline clinical criteria: digoxin co-prescription, advanced heart failure, coronary artery disease, or the presence of permanent AF. These analyses allowed the calculation of a global treatment effect in two important patient subgroups, those with permanent AF in whom there was harm with respect to cardiovascular mortality [hazard ratio (HR) = 2.32; 95% confidence interval (CI) 1.13–4.75] and hospitalization for heart failure (HR = 1.674; 95% CI 1.05–2.67); and those with non-permanent AF in whom there was benefit in terms of cardiovascular hospitalization [HR = 0.751 95% CI (0.68–0.83)]. Conclusion This meta-analysis demonstrates significant heterogeneity of dronedarone treatment effects across the placebo-controlled randomized trials. The most important predictor of a harmful effect of dronedarone on cardiovascular death and heart failure hospitalization was the presence of permanent AF.
- Subjects :
- medicine.medical_specialty
Digoxin
Amiodarone
Coronary artery disease
Risk Factors
Physiology (medical)
Internal medicine
Atrial Fibrillation
medicine
Humans
Dronedarone
Proportional Hazards Models
Heart Failure
Proportional hazards model
business.industry
Hazard ratio
Atrial fibrillation
medicine.disease
Hospitalization
Treatment Outcome
Heart failure
Cardiology
Cardiology and Cardiovascular Medicine
business
Anti-Arrhythmia Agents
medicine.drug
Subjects
Details
- ISSN :
- 15322092
- Volume :
- 16
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
- Accession number :
- edsair.doi.dedup.....9851cc28cf33b031c16c3b2ad0f76a9d