Evaluation of dabigatran utilization and risk among hospitalized patients.
Author(s): Sidman E(1), Probst LA, Darko W, Miller CD.
Affiliation(s): Author information:
(1)Upstate University Hospital, Syracuse, NY, USA.
Publication date & source: 2014, Ann Pharmacother. , 48(3):349-53
BACKGROUND: Few data exist to evaluate the use of dabigatran among hospitalized
patients and this population that may be at increased risk for toxicity or
reduced efficacy. As such, the objectives of this study were to describe the
characteristics of hospitalized patients prescribed dabigatran and to compare
select characteristics with patients included in the Randomized Evaluation of
Long-Term Anticoagulation (RE-LY) phase III clinical trial.
METHODS: A cross-sectional study was performed at Upstate University Hospital.
Select patient characteristics, including age, renal function, and drug
interaction exposure, were compared with those for patients in the RE-LY trial.
RESULTS: The study included 140 patients. Mean age was 69.7 years (SD = 13.8) and
72 (51.4%) were male. The mean CHADS2 score was 2.48 as compared with 2.2 in
RE-LY. Significantly more patients in our study had moderate to severe renal
dysfunction (creatinine clearance [CrCl] < 50 mL/min) as compared with the RE-LY
trial (27.5% vs 19.4%, P = .0207) when analyzing our study patients' worst
recorded CrCl. Among the 29 patients prescribed dose-adjusted dabigatran, 3 were
correctly dose adjusted, 2 were overdosed, and 26 were underdosed. At least 1
pharmacokinetic drug interaction with dabigatran occurred in 110 study patients
(78.6%). Use of proton pump inhibitors was more predominant in our study
population when compared with RE-LY (64.3% vs 13.9%, P < .0001).
CONCLUSIONS: Hospitalized patients exhibit multiple characteristics that place
them at heightened risk for altered dabigatran drug concentrations and may have a
heightened risk for clinical sequelae related to dabigatran use.
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