ATHENA study

Introduction

International study sponsored & administered by the manufacturer of dronedarone

Study characteristics:

• placebo-controlled
• 21 months of follow-up

Subjects:

• 4628 patients
• eligible patients had atrial fibrillation & at least one of the following conditions:
  • hypertension
  • diabetes
  • previous stroke or transient ischemic attack
  • left atrial enlargement, or LV ejection fraction of <= 40%;
    • 3.9% of participants had LVEFs <=35%

Groups:

• dronedarone (400 mg BID) or placebo

Results:

• number of first cardiac hospitalizations was significantly lower in the dronedarone group than in the placebo group, largely due to fewer hospitalizations for atrial fibrillation
• a statistically significant reduction in hospitalization for acute coronary syndrome also observed

More general terms

• clinical trial