An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Dabigatran Etexilate in Hemodialysis Patients

Summary

Patients with end stage renal disease carry a high risk for atrial fibrillation (AF) and require oral anticoagulant therapy for prevention of stroke. Often, the oral anticoagulant, warfarin sodium, is prescribed. Managing dialysis patients on warfarin can be fraught will difficulties given the multitude of drug and food interactions, need for frequent coagulation monitoring and dosage adjustment, and concern that warfarin enhances vascular calcification in dialysis patients. Recently, dabigatran etexilate, a direct oral thrombin inhibitor, has been approved for use in AF patients with normal renal function. Since many drugs are eliminated by the kidneys and removed from the plasma during dialysis, it is important to determine proper drug dosing in hemodialysis patients through evaluating pharmacokinetics.

Timeline

Start

2012-07

Primary completion

2012-09

Completion

2012-09

Publications

• Wilson JA, Goralski KB, Soroka SD, Morrison M, Mossop P, Sleno L, Wang Y, Anderson DR. An evaluation of oral dabigatran etexilate pharmacokinetics and pharmacodynamics in hemodialysis. J Clin Pharmacol. 2014 Aug;54(8):901-9. doi: 10.1002/jcph.335. Epub 2014 May 28.

Drugs

Indications