title: Dosage Adjustment of Dabigatran Etexilate Based on Creatinine Clearance in Patients With Cardioembolic Stroke or Atrial Fibrillation.
abstract: A recommendation for dosage adjustment of dabigatran etexilate, a prodrug of dabigatran, seems to be desirable based on creatinine clearance to avoid bleeding and stroke.
  
  
  
  Outpatients and inpatients having a history of cardioembolic stroke or atrial fibrillation were included. After taking dabigatran etexilate orally (75-150 mg twice daily) for at least 1 week, plasma trough concentration (Ctrough, ng/mL) of dabigatran and creatinine clearance (CLcr, mL/min) of patients according to Cockcroft and Gault equation were determined.
  
  
  
  Among the 38 patients studied, Ctrough of dabigatran and CLcr were scattered in a range from 31.4 to 329.5 ng/mL and 15.4-133.4 mL/min, respectively. Temporal CLtotal (Temp-CLtotal) of dabigatran, estimated by dividing the daily absorbed amount of dabigatran etexilate with Ctrough of dabigatran, was linearly correlated with CLcr of patients (P = 0.0018). Based on the findings, the daily dose of dabigatran etexilate that provides Ctrough of dabigatran at approximately 70 ng/mL was estimated.
  
  
  
  A linear relationship was found between Temp-CLtotal of dabigatran and CLcr of patients. Depending on CLxr of patients, we recommend 4 different dosages of dabigatran etexilate to obtain Ctrough of dabigatran at approximately 70 ng/mL.
authors: *Department of Pharmacy, Chugoku Rosai Hospital; and †Laboratory of Biopharmaceutics and Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Hiroshima International University, Kure, Japan.
authors: Shohei
authors: S
authors: Matsuda
authors: Tomoko
authors: T
authors: Imazu
authors: Ryuji
authors: R
authors: Kimura
authors: Mamoru
authors: M
authors: Nakamura
authors: Atsushi
authors: A
authors: Matsumoto
authors: Teruo
authors: T
authors: Murakami
authors: Yorinobu
authors: Y
authors: Maeda
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000008:administration & dosage* / Q000097:blood; D001281:Atrial Fibrillation / Q000097:blood / Q000188:drug therapy*; D003404:Creatinine / Q000097:blood / Q000378:metabolism*; D000069604:Dabigatran / Q000008:administration & dosage* / Q000097:blood; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011355:Prodrugs / Q000008:administration & dosage; D020521:Stroke / Q000097:blood / Q000188:drug therapy*
chemical_list: D000991:Antithrombins; D011355:Prodrugs; D003404:Creatinine; D000069604:Dabigatran