利伐沙班-济源第二人民医院.ppt

Bristol-Myers Squibb/Pfizer A Phase III Study of Apixaban in Patients With AF The purpose of this clinical research study is to learn if apixaban is more effective than Acetylsalicylic Acid (ASA) in preventing strokes associated with subjects who have atrial fibrillation. The safety of this treatment will also be studied. * AVERROES是一项随机双盲试验，旨在房颤患者中比较阿匹沙班和阿司匹林的疗效。入选全球522所医院的5600例房颤患者（平均年龄70岁，具有≥1项卒中危险因素），患者因难以控制治疗效果、出血风险增加、拒绝服用华法林等原因不适合维生素K拮抗剂（VKA）治疗。将患者随机分为阿匹沙班组（5 mg BID，部分患者2.5mg BID）和阿司匹林组（81-324 mg)。主要疗效终点是卒中和系统性栓塞，主要安全性终点是严重出血。次要和三级终点是卒中、系统性栓塞、心肌梗死、血管性死亡和全因死亡。 * A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation * * * * * * * * * 该项研究共纳入BDAT、TPT、SALT 、UK-TIA四项阿司匹林随机对照实验，总计14 033例患者，平均治疗时间为6年，平均随访时间18.3年。结果显示：长期服用阿司匹林可显著降低患者结肠癌风险率，结肠癌发病率降低24%，死亡率降低35%。 * 该研究纳入TPT、SALT 、UK-TIA(阿司匹林300mg组)三项低剂量阿司匹林（75-300mg）随机对照试验中预定治疗时间≥2.5年和≥5年的患者。 与对照组相比，低剂量阿司匹林（75-300 mg）治疗时间延长，患者获益进一步增加，治疗时间≥2.5年与≥5年患者发病率风险分别为0.69、0.62；死亡率风险分别为0.54、0.48. * * * 两组监测INR的频率相同 Background—Pharmacogenetic-guided dosing of warfarin is a promising application of “personalized medicine” but has not been adequately tested in randomized trials. Methods and Results—Consenting patients (n206) being initiated on warfarin were randomized to pharmacogeneticguided or standard dosing. Buccal swab DNA was genotyped for CYP2C9 *2 and CYP2C9 *3 and VKORC1 C1173T with a rapid assay. Standard dosing followed an empirical protocol, whereas pharmacogenetic-guided dosing followed a regression equation including the 3 genetic variants and age, sex, and weight. Prothrombin time international normalized ratio (INR) was measured routinely on days 0, 3, 5, 8, 21, 60, and 90. A research pharmacist unblinded to treatment strategy managed dose adjustments. Patients were followed up for up to 3 months. Pharmacogenetic-guided predicted doses more accuratel