INR measurements generated by POC devices exhibited positive bias, compared with laboratory-based venipuncture, for INR values at the high end of the INR range.

BackgroundVitamin K antagonists have been the treatment of choice in preventing thromboembolic events, but problems such as frequent dose adjustment and monitoring of coagulation status, including multiple drug and food interactions, make their use difficult. Dabigatran etexilate is a new oral direct thrombin inhibitor not requiring routine monitoring and since its approval in the United States, many clinicians have been interested in utilizing this new therapy.ObjectiveThis study documented adverse drug events (ADEs) recorded in patients started on dabigatran therapy, including those who were previously controlled on warfarin and those who were anticoagulant naïve.MethodsIn an outpatient pharmacist-managed anticoagulation clinic, a total of 221 patients were initiated on dabigatran therapy over an 18-month period. 43.0% of these patients were previously controlled on warfarin.Results54 of the 221 patients (24.4%) developed an ADE while on dabigatran. The average time to event was 48.4 days. Nine of the fifty-four patients experienced a major bleeding ADE; six patients developed a serious non-bleeding ADE. Five of these fifteen patients died; one death was directly related to dabigatran therapy. The remaining thirty-nine of the fifty-four patients experienced a clinically relevant non-major ADE. Of the fifty-four patients who experienced an ADE, thirty were male. The average age was 73.8 years and the average weight was 92.8kg. Fifty-four percent of those who experienced an ADE were previously anticoagulant naïve.ConclusionsWhile many clinicians have been interested in utilizing the new direct thrombin inhibitor dabigatran etexilate, this new therapy is not without risks. This study documented adverse drug events in 24.4% of patients who were initiated on dabigatran etexilate therapy over an eighteen month period. ADEs were more common in patients who were anticoagulant naïve prior to dabigatran etexilate therapy and not those who were previously controlled on warfarin therapy.

as opposed to the aforementioned factor of 1.86. If the new dosage of 110 mg twice daily were used for CL cr values of 30-50 mL/min, the average C ss values would be similar: 0.231, 0.236, and 0.235 mg/mL for CL cr values of >50, 30-50, and <30 mL/min, respectively. Dosages appearing in dabigatran product labeling may not be optimal for patients with a CL cr of 30-50 mL/min. For this group, a dabigatran etexilate dosage of 110 mg orally twice daily may produce a better balance of safety and effectiveness. A 110-mg dosage form of dabigatran etexilate is available in Canada but not in the Unit-5. Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361:1139-51. 6. Hankey GJ, Eikelboom JW. Dabigatran etexilate: a new oral thrombin inhibitor.ed States, but a 150-mg capsule could be taken in the morning and a 75-mg capsule at night.