Amiodarone to Prevent Post-Operative Arrhythmias

Phase 3 Completed 600 enrolled University of Calgary Heart and Stroke Foundation of Canada · collab Wyeth is now a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

Rapid heart rhythms originating from the upper heart chambers (atrial tachyarrhythmias) are very common after open-heart surgery. The hypothesis of the PAPABEAR study is that a brief (13 day) peri-operative course of oral amiodarone therapy would be effective and safe for the prevention of these post-operative atrial tachyarrhythmias.

Timeline

Start: 1999-02
Primary completion: —
Completion: 2004-09

Outcome

Met primary endpoint

paper Atrial tachyarrhythmias occurred in fewer amiodarone patients (48/299; 16.1%) than in placebo patients (89/302; 29.5%) overall PMID 16380589 ↗

paper 95% confidence interval [CI], 0.34-0.69; P<.001 PMID 16380589 ↗

Publications

Results Mitchell LB, Exner DV, Wyse DG, Connolly CJ, Prystai GD, Bayes AJ, Kidd WT, Kieser T, Burgess JJ, Ferland A, MacAdams CL, Maitland A. Prophylactic Oral Amiodarone for the Prevention of Arrhythmias that Begin Early After Revascularization, Valve Replacement, or Repair: PAPABEAR: a randomized controlled trial. JAMA. 2005 Dec 28;294(24):3093-100. doi: 10.1001/jama.294.24.3093.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amiodarone	Small molecule	10 mg/kg	Oral