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.
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.
Authors: Hisham A Badreldin; Jahad Alghamdi; Omar Alshaya; Abdulmajeed Alshehri; Lamya Alreshoud; Renad Altoukhi; Senthilvel Vasudevan; Wesam W Ismail; Mohamed Salih Aziz Mohamed Journal: Int J Gen Med Date: 2020-07-22