Introduction: The ATHENA trial randomized atrial fibrillation/flutter (AF/AFL) patients (pts) with ≥1 other cardiovascular (CV) risk factors to dronedarone (n=2301) or placebo (n=2327), plus standard care. Dronedarone reduced the rate of first CV hospitalization over the study period (mean ± SD 21 ± 5 months). This analysis assesses, from a US perspective, potential cost savings from the reduction in overall (first + subsequent) CV hospitalizations in ATHENA. Methods: Using a cost analysis model, we applied hospitalization costs reported from a US cohort of AF/AFL pts to hospitalization events among the ATHENA population. Clinical inputs included all CV- and adverse event (AE)-related hospitalizations over the ATHENA study period. Cost inputs (2008 values) were (i) weighted mean CV hospitalization costs (non-fatal + fatal combined), categorised according to cause of admission, derived from claims data for a cohort of ATHENA-like AF/AFL pts (n=10,200) with Medicare supplemental insurance, and (ii) DRG costs of hospitalizations for AEs recorded in ATHENA. Cost variations were assessed using Monte Carlo sensitivity analysis. Results: In ATHENA, overall CV hospitalization rate fell by 25% with dronedarone (1177/2301 vs 1596/2327, dronedarone vs placebo arms). Based on the observed hospitalization rates and derived hospitalization costs (Table), overall cost savings with dronedarone were estimated at (mean ± SD) $1763 ± 207 per pt over the ATHENA study period. The estimated savings in CV hospitalization costs (mean $1777 per pt) heavily outweighed the added estimated AE hospitalization costs (mean $14 per pt). Sensitivity analysis showed that the cost offset was relatively stable (range $1023−$2596 over 10,000 cycles of random variation). Conclusions: Dronedarone reduced the overall CV hospitalization rate by 25% in the ATHENA population, resulting in estimated mean hospitalization-related cost savings of $1763 per pt over the study period. Cause of hospitalization Number of hospitalizations per 100 patients 1 Default cost per hospitalization Hospitalization cost saving per patient Placebo + standard care Dronedarone + standard care Myocardial infarction or unstable angina 4.86 3.09 $17,360 $307 Cardiac arrhythmia and conduction disorders 2 36.18 22.82 $8,601 $1,150 Cardiovascular surgery (bypass/PCI) 3 4.38 3.91 $21,233 $100 Worsening heart failure, including pulmonary edema or dyspnea of cardiac origin 7.91 7.17 $9,945 $73 Implantation of a pacemaker, ICD or any other cardiac device 3.57 2.83 $18,272 $136 Transient ischemic attack or stroke (except intracranial hemorrhage) 2.75 2.00 $9,006 $68 Other cardiovascular 4 8.90 9.34 $12,807 −$57 Total cardiovascular hospitalizations 68.55 51.15 − $1,777 Adverse events 5 0.26 0.56 $4,681 −$14 All hospitalization events 68.81 51.71 − $1,763 Abbreviations : ICD, implantable cardiac defibrillator; PCI, percutaneous coronary intervention 1. Numbers are rounded up/down from 3 decimal places. 2. Atrial fibrillation and other supraventricular rhythm disorders and ventricular tachycardia (non-sustained and sustained VT), ventricular fibrillation and ventricular extrasystoles and other ventricular arrhythmia. 3. Transcutaneous coronary, cerebrovascular or peripheral procedures and cardiovascular surgery, except cardiac transplantation. 4. Cardiac transplantation, cardiovascular infection, pulmonary embolism or deep vein thrombosis, non-fatal cardiac arrest, major bleeding (requiring ≥2 units of blood or any intracranial hemorrhage), atherosclerosis-related (if not otherwise specified), syncope, blood pressure-related (hypotension, hypertension; except syncope), stable angina pectoris or atypical chest pain. 5. Non-cardiovascular and treatment-related.
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