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Assessment of dabigatran utilization and prescribing patterns for atrial fibrillation in a physician group practice
Blake Carley1, Sara Griesbach1, Tonja Larson1
1Clinical Pharmacy Services Department of Marshfield Clinic, Marshfield, Wisconsin.
Insights
Dabigatran, a novel oral anticoagulant, showed significant off-label use and required careful monitoring of renal function and drug interactions in a physician group practice. Many patients previously on warfarin switched back, highlighting the need for anticoagulation services and clear guidance for novel oral anticoagulants.
Area of Science:
- Pharmacology
- Cardiology
- Health Services Research
Background:
- Warfarin and aspirin were standard stroke prophylaxis for atrial fibrillation.
- Dabigatran, an oral direct thrombin inhibitor, became available in late 2010 for nonvalvular atrial fibrillation.
Purpose of the Study:
- To evaluate the utilization and prescribing patterns of dabigatran in a physician group practice.
- To assess off-label use, dosing, renal function impact, drug interactions, and warfarin retreatment in patients prescribed dabigatran.
Main Methods:
- Retrospective collection of prescription data from October 2010 to December 2011.
- Analysis included indication, dose, renal function (Cockcroft-Gault), drug interactions, warfarin history, and risk scores (CHADS2, HAS-BLED).
Main Results:
- 20% of patients (n=34) had off-label dabigatran use.
- Half of patients with reduced renal function (15-30 ml/min) required dose adjustment; one case was contraindicated.
- 68% previously used warfarin; 20% eventually resumed warfarin.
- Increased use of P-glycoprotein and proton pump inhibitors observed post-dabigatran initiation.
- Nearly 10% of patients had a CHADS2 score of 0.
Conclusions:
- Dabigatran utilization in a group practice revealed significant off-label use and the critical need for renal function monitoring and drug interaction assessment.
- Patient management requires careful consideration of prior warfarin use and potential need for re-initiation.
- Anticoagulation services and "place in therapy" guidance are crucial for safe and effective use of novel oral anticoagulants.
Abstract:
For years, warfarin and aspirin have been standard therapies for prophylaxis of stroke in atrial fibrillation. In late 2010, dabigatran, an oral direct thrombin inhibitor, became available for use in nonvalvular atrial fibrillation. We sought to evaluate utilization and prescribing patterns of dabigatran in a physician group practice setting. We retrospectively collected prescription data from October 2010 to December 2011 including indication of use, dose, renal function, drug interactions, history of warfarin therapy, and risk assessment scores (CHADS2 and HAS-BLED). Off-label use (history of valve disease or no diagnosis of atrial fibrillation) occurred in 20% (n = 34) of 174 patients. Renal function assessed by Cockcroft-Gault equation identified 1 case of contraindicated use and the need for initial renal dose adjustment in approximately 1/2 of the patients with reduced renal function (15-30 ml/min). Review of anticoagulant use revealed 68% of patients (n = 119) previously received warfarin and ultimately 20% of all patients on dabigatran resumed warfarin therapy. A significant increase in the use of permeability glycoprotein inhibitors and proton pump inhibitors after initiating dabigatran was observed. Nearly 10% of patients had a CHADS2 score of 0. For patients receiving novel oral anticoagulants, prospective inclusion in anticoagulation services and guidance from specific "place in therapy" statements have potential to play a large role in maximizing safety while aiding in continued research.
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