Abstract
The ATHENA clinical trial enrolled 4,628 patients in 37 countries and evaluated the efficacy of dronedarone 400 mg twice daily versus placebo for the prevention of cardiovascular hospitalisation or death from any cause in patients with paroxysmal or persistent atrial fibrillation or atrial flutter. The trial showed a statistically significant 24 % reduction in the primary endpoint cardiovascular hospitalisations or all-cause death. In the current paper, parameters that drive the cost-effectiveness of dronedarone on top of standard therapy versus likely comparators, i.e. amiodarone, sotalol and flecainide, were investigated by means of a health economic model based on the ATHENA clinical trial. Dronedarone is cost-effective, and ICERs are low versus amiodarone with €5,340; €4,620; €3,850 and €5,630 per QALY gained for Canada, Italy, Sweden and Switzerland, respectively. The most significant driving factor for the cost-effectiveness of dronedarone is the increased survival rate for patients on dronedarone.
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Abbreviations
- AAD:
-
Antiarrhythmic drug
- ACS:
-
Acute coronary syndrome
- AE:
-
Adverse events
- AF:
-
Atrial fibrillation
- AFL:
-
Atrial flutter
- CAD:
-
Coronary artery disease
- CHADS2 :
-
Score estimating the risk of stroke and based on the condition of the patient regarding CHF, hypertension, age, diabetes mellitus, prior stroke or TIA
- CHF:
-
Congestive heart failure
- CV:
-
Cardiovascular
- ICER:
-
Incremental cost-effective ratio
- LVEF:
-
Left ventricular ejection fraction
- LYG:
-
Life year gained
- MTC:
-
Mixed treatment comparison
- QALY:
-
Quality adjusted life-year
- SHD:
-
Structural heart disease
- TIA:
-
Transient ischemic attack
- MSE:
-
Main safety endpoint
- SOC:
-
Standard of care
- SPC:
-
Summary of product characteristics
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Acknowledgments
This study was funded by Sanofi-Aventis.
Conflict of interest
J.N., Ö.Å. and P.L. are employees of a clinical research organization (CRO) having Sanofi-Aventis as a client. G.B.B. is a Sanofi-Aventis employee. M.R. is a clinical expert in cardiology from Södersjukhuset in Sweden.
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Nilsson, J., Åkerborg, Ö., Bégo-Le Bagousse, G. et al. Cost-effectiveness analysis of dronedarone versus other anti-arrhythmic drugs for the treatment of atrial fibrillation—results for Canada, Italy, Sweden and Switzerland. Eur J Health Econ 14, 481–493 (2013). https://doi.org/10.1007/s10198-012-0391-x
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DOI: https://doi.org/10.1007/s10198-012-0391-x