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document
Impact of dronedarone on hospitalization burden in patients with atrial fibrillation : results from the ATHENA study . AIMS Cardiovascular ( CV ) hospitalization is a predictor of CV mortality and has a negative impact on patients ' quality of life . The primary endpoint of A placebo-controlled , double-blind , parallel-arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENTs with Atrial fibrillation/atrial flutter ( ATHENA ) , a composite of first CV hospitalization or death from any cause , was significantly reduced by dronedarone . This post hoc analysis evaluated the secondary endpoint of CV hospitalization and the clinical benefit of dronedarone on the number and duration of CV hospitalizations in patients with atrial fibrillation ( AF ) . METHODS AND RESULTS ATHENA was a double-blind , parallel group study in 4628 patients with a history of paroxysmal/persistent AF and additional risk factors , treated with placebo or dronedarone . Dronedarone treatment significantly reduced the risk of first CV hospitalization ( P < 0.0001 vs. placebo ) , while the risk of first non-CV hospitalization was similar in both groups ( P = 0.77 ) . About half of the CV hospitalizations were AF-related , with a median duration of hospital stay of four nights . The risk of any hospitalization for AF [ hazard ratio ( 95 % confidence interval ) 0.626 ( 0.546-0.719 ) ] and duration of hospital stay were significantly reduced by dronedarone ( P < 0.0001 vs. placebo ) . Dronedarone treatment reduced total hospitalizations for acute coronary syndrome ( P = 0.0105 ) and the time between the first AF/atrial flutter recurrence and CV hospitalization/death ( P = 0.0048 ) . Hospitalization burden was significantly reduced across all levels of care ( P < 0.05 ) . Cumulative incidence data indicated that the effects of dronedarone persisted for at least 24 months . CONCLUSION Dronedarone reduced the risk for CV hospitalization and the total hospitalization burden in this patient group . The trial is registered under ClinicalTrials.gov # NCT 00174785 .
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Intervention_Pharmacological
dronedarone
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Intervention_Pharmacological
dronedarone
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Intervention_Pharmacological
dronedarone
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Intervention_Pharmacological
dronedarone
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Intervention_Pharmacological
placebo
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Intervention_Pharmacological
dronedarone
50258
Intervention_Pharmacological
Dronedarone
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Intervention_Control
placebo
50260
Intervention_Pharmacological
dronedarone
50261
Intervention_Control
placebo
50262
Intervention_Pharmacological
Dronedarone
50263
Intervention_Pharmacological
dronedarone
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Intervention_Pharmacological
Dronedarone
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Outcome_Other
hospitalization burden
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Outcome_Mortality
CV mortality
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Outcome_Other
quality of life .
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Outcome_Other
efficacy
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Outcome_Physical
cardiovascular Hospitalization
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Outcome_Mortality
death
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Outcome_Other
CV hospitalization
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Outcome_Other
clinical benefit
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Outcome_Other
CV hospitalizations
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Outcome_Other
reduced the risk of first CV hospitalization
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Outcome_Other
non-CV hospitalization
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Outcome_Other
CV hospitalizations
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Outcome_Physical
AF-related
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Outcome_Other
hospital stay
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Outcome_Other
hospital stay
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Outcome_Other
reduced total hospitalizations
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Outcome_Mortality
first AF/atrial flutter recurrence and
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Outcome_Other
CV hospitalization/death
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Outcome_Other
Hospitalization burden
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Outcome_Other
CV hospitalization
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Outcome_Other
hospitalization burden
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Participant_Condition
patients with atrial fibrillation :
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Participant_Condition
patiENTs with Atrial fibrillation/atrial flutter ( ATHENA )
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Participant_Condition
4628 patients with a history of paroxysmal/persistent AF and additional risk factors