Apixaban, an oral direct factor Xa inhibitor, is currently in late stage clinical development for the prevention and treatment of thromboembolic diseases. In comparison with current treatment standards for venous thromboembolism (VTE) prophylaxis, apixaban has shown decreased rates of clinically significant bleeding with mixed results in terms of non-inferiority for VTE events. Secondary treatment of VTE with apixaban is currently in phase III clinical study after earlier trials showed comparable safety and efficacy outcomes. The APPRAISE-1 trial, a phase II investigation of apixaban versus placebo following acute coronary syndrome showed a higher risk of clinically significant bleeding in addition to a trend toward decreased ischemic events. A large, international phase III clinical study (APPRAISE-2) of apixaban following acute coronary syndrome is currently underway. Large, phase III studies testing apixaban for the prevention of vascular events in subjects with non-valvular atrial fibrillation are also ongoing.

译文

阿哌沙班是一种口服直接因子Xa抑制剂,目前在预防和治疗血栓栓塞性疾病方面处于晚期临床开发阶段。与目前预防静脉血栓栓塞 (VTE) 的治疗标准相比,阿哌沙班的临床显着出血率降低,VTE事件的非劣效性结果参差不齐。在早期试验显示出相当的安全性和有效性结果后,阿哌沙班的VTE二次治疗目前处于III期临床研究中。评估-1试验是急性冠状动脉综合征后阿哌沙班与安慰剂的II期研究,除了缺血性事件减少的趋势外,临床上显着出血的风险更高。目前正在进行急性冠状动脉综合征后阿哌沙班的大型国际III期临床研究 (评估-2)。大型III期研究也在进行中,测试阿哌沙班预防非瓣膜性房颤患者的血管事件。

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