Dabigatran Use in the Real World: A Multihospital System Experience

Area of Science:

• Pharmacology
• Clinical Pharmacy
• Cardiology

Background:

• Dabigatran etexilate, an oral direct thrombin inhibitor, is FDA-approved for stroke risk reduction in nonvalvular atrial fibrillation (NVAF).
• The Randomized Evaluation of Long-term anticoagulant therapY (RE-LY) study established dabigatran's efficacy and safety.
• Real-world drug use and outcomes may differ from clinical trial data post-approval.

Purpose of the Study:

• To describe dabigatran etexilate use in routine clinical practice.
• To evaluate appropriate prescribing for indication and dose.
• To assess clinical outcomes including bleeding, myocardial infarction, and stroke.

Main Methods:

• Retrospective chart review of 160 patients across 4 adult hospitals (1 academic, 3 community).
• Analysis of dabigatran indication, starting dose, and concomitant medication use.
• Assessment of clinical outcomes over a 6-month follow-up period.

Main Results:

• Appropriate indication for NVAF in 91% of patients.
• Appropriate dabigatran dosing in 90% of patients; common reason for inappropriate dosing was perceived bleeding risk.
• Bleeding complications occurred in 6 patients (3.8%), with 5 cases of gastrointestinal bleeding.

Conclusions:

• Dabigatran etexilate is generally prescribed appropriately for NVAF in real-world settings.
• Potential for optimizing dosing and minimizing bleeding risk through enhanced prescriber education.
• Active pharmacist involvement is crucial for ensuring appropriate dabigatran use and patient safety.