新型口服抗凝药引领未来.pptVIP

结论 在RECORD研究中，与标准治疗方案相比，利伐沙班的获益－风险比更佳 显著降低了下列复合终点事件的发生率: 症状性静脉血栓栓塞症（ VTE） 心血管事件 全因死亡 大出血 * Random effects approach is more conservative than fixed effects approach – yields wider confidence intervals allowing for trial heterogeneity. REFERENCE Wolowacz SE et al. Efficacy and safety of dabigatran etexilate for the prevention of venous thromboembolism following total hip or knee arthroplasty. Thromb Haemost 2009;101: 77-85. * Rivaroxaban is a novel, oral, direct Factor Xa inhibitor1 Rivaroxaban has predictable dose-proportional pharmacokinetics and pharmacodynamics in healthy subjects, and showed no evidence of accumulation after multiple dosing2 Studies in healthy subjects showed that rivaroxaban had no clinically relevant interactions with acetylsalicylic acid or naproxen.3,4 Further studies demonstrated that the pharmacology of rivaroxaban was not affected by age, gender or weight to a clinically relevant degree, suggesting that fixed dosing should be possible for all patients5,6 The phase II development programme of rivaroxaban involved four studies of rivaroxaban for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery7–10 All of the doses investigated in the three double-blind studies of rivaroxaban in this indication (5–60 mg), had similar efficacy compared with the low molecular weight heparin enoxaparin8–10 There were dose–response relationships between rivaroxaban and major bleeding in all of the studies; however, there were no significant differences in the observed incidence of major bleeding between rivaroxaban and enoxaparin in any study8–10 These findings suggest that rivaroxaban has a wide therapeutic window When efficacy and safety were considered together, rivaroxaban 10 mg once daily (od) was selected for further investigation in the RECORD programme10 1. Perzborn E et al. J Thromb Haemost 2005;3:514–521. 2. Kubitza D et al. Eur J Clin Pharmacol 2005;61:873–880. 3. Kubitza D et al. J Clin Pharmacol 2006;46:981–990. 4