Comparison of warfarin time in the therapeutic range at a pharmacist-run anticoagulation clinic and the RE-LY trial.

Am J Health Syst Pharm

Matthew Biszewski, Pharm.D., BCACP, is Clinical Specialist; and Diane Nitzki-George, Pharm.D., M.B.A., is Clinical Specialist, Thrombosis and Anticoagulation Unit, NorthShore University HealthSystem, Glenbrook Hospital, Glenview, IL. Ying Zhou, Ph.D., is Statistician, Center for Biomedical and Research Informatics, NorthShore University HealthSystem, Evanston, IL.

Published: April 2015

Purpose: An audit was conducted to determine if the benefits of dabigatran treatment, as demonstrated in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial, are applicable to patients with nonvalvular atrial fibrillation managed by a pharmacist-run anticoagulation clinic (PAC).

Methods: The records of warfarin-treated patients managed by a PAC program over a three-year period were screened to identify patients with diagnosed nonvalvular atrial fibrillation and a goal International Normalized Ratio (INR) of 2-3; the case selection criteria were similar to those used in the RE-LY trial. Abstracted data included dates and results of INR monitoring and information needed to calculate CHADS2 (Congestive Heart Failure, Hypertension, Age, Diabetes, and Stroke [doubled]) scores. Warfarin time in the therapeutic range (TTR) was the primary endpoint. A pairwise comparison of TTR distributions in subsets of patients grouped by CHADS2 score was performed to test the hypothesis that any two groups had identical distributions.

Results: Data on 314 PAC patients, including 9772 INR values, were analyzed. The mean±S.D. TTR was 62.4%±24.5% (median, 66.7%), which was similar to the mean TTR reported in the RE-LY trial (p=0.092). The distribution of TTR values in the PAC population differed significantly in patients with a CHADS2 score of 2 versus a score of 3 (p=0.0333 for Kuiper test), but no other significant differences were noted.

Conclusion: TTR values among PAC-managed patients with nonvalvular atrial fibrillation were comparable to those reported in the RE-LY trial.

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http://dx.doi.org/10.2146/ajhp130800DOI Listing

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