达比加群临床用药建议.ppt

病历分析(1) 病历分析(2) Impact of dabigatran on a large panel of routine or specific coagulation assays aPTT = activated partial thromboplastin time; HTI = Hemoclot Thrombin Inhibitor; ECA = ecarin chromogenic assay; ECT = ecarin clotting time(蛇静脉酶凝结时间); TGA = thrombin generation Assay; TT = thrombin time; PT = prothrombin time In patient taking 150 mg DE bid regimen, an aPTT above 80 sec at trough (corresponding normally to a Ctrough = 200 ng/ml) is correlated with an increased risk of bleeding This cut-off is reduced to 45 sec (corresponding normally to a Ctrough = 67 ng/ml) for patients taking 220 mg DE qd for primary prevention of VTE Effects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assays If a patient on dabigatran has prolonged APTT 90 sec, and Quick PT INR2 or Owren PT INR1.5, over-dosing or accumulation of dabigatran should be considered. These results are indicative of a concentration of dabigatran ≥600 μg/L, based on data from the PETRO trial less than1% of the patients on 150 mg bid would have Cmax ≥600 μg/L RELY Asian subgroup analysis Dabigatran Versus Warfarin Effects on Ischemic and Hemorrhagic Strokes and Bleeding in Asians and Non-Asians With Atrial Fibrillation The effects of dabigatran against stroke and SE are similar in Asian and non-Asian patients for both doses of dabigatran compared with warfarin. Although Asian patients on warfarin had considerably more time below therapeutic range and were younger, there was a trend for more bleeding in Asian than in non-Asian patients. Dabigatran reduced the risk of bleeding outcomes more in Asians than in non-Asians. Pharmacokinetics and pharmacodynamics in Japanese and Caucasian subjects after oral administration of dabigatran etexilate Dabigatran 150 mg twice-daily has been approved in the US, Canada, Europe and Japan for prevention of stroke in patients with AF A dose of 220 mg once-daily is approved for the prevention of VTE after hip or knee arthroplasty in more tha