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Assessment of dronedarone utilization using US claims databases.

Jasmanda Wu1, Jane Thammakhoune1, Wanju Dai1

  • 1Global Phamacovigilance and Epidemiology, Sanofi, Bridgewater, New Jersey.

Clinical Therapeutics
|February 4, 2014
PubMed
Summary

Dronedarone use in patients with heart failure (HF) and concomitant drug prescriptions were evaluated. The study found dronedarone was mostly used appropriately, aligning with US prescribing guidelines.

Keywords:
Risk Evaluation and Mitigation Strategydronedaronedrug utilization

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Area of Science:

  • Cardiology
  • Pharmacovigilance
  • Real-world evidence

Background:

  • Dronedarone is an antiarrhythmic drug used for atrial fibrillation.
  • Assessing real-world drug utilization is crucial for patient safety.
  • Previous studies indicated potential risks with dronedarone in heart failure (HF) patients.

Purpose of the Study:

  • To estimate dronedarone use in patients with contraindications like worsening or recent HF hospitalization.
  • To determine the prevalence of concomitant prescribing of contraindicated drugs with dronedarone.
  • To assess the rate of recommended creatinine testing post-dronedarone initiation.

Main Methods:

  • Retrospective cohort study analyzing US MarketScan and InVision Data Mart databases (2009-2012).
  • Included patients with at least one dronedarone prescription.
  • Evaluated HF events, co-prescribing of CYP3A4 inhibitors/QT-prolonging drugs, and creatinine testing.

Main Results:

  • Over 38,000 dronedarone users were identified across both databases.
  • Prevalence of worsening/hospitalized HF within 1 month prior to prescription was 4.7-6.4%.
  • Concomitant prescribing of contraindicated drugs was low (2.0-2.3% for CYP3A4 inhibitors, 10.0-11.2% for QT-prolonging drugs); >50% received creatinine testing.

Conclusions:

  • Dronedarone utilization in the US appears largely compliant with prescribing guidelines.
  • Real-world data suggest appropriate use in the target population.
  • Findings support previous observations on dronedarone's appropriate use.