抗凝剂拜瑞妥的3项新适应证获批

圣路易斯(MD Consult)——2012年11月2日，美国食品药品管理局(FDA)和杨森(Janssen Pharmaceuticals)宣布，口服抗凝剂拜瑞妥(利伐沙班)已正式获准用于深静脉血栓形成(DVT)和/或肺栓塞(PE)的治疗，也可用于降低初始治疗后DVT和PE的复发风险。拜瑞妥之前已获准用于降低膝关节或髋关节置换术后的DVT和PE风险，以及降低非瓣膜性房颤患者的卒中风险。

拜瑞妥用于这些新适应证的安全性和有效性通过3项临床研究进行评估。共有9,478例DVT或PE患者被随机分配至接受拜瑞妥、依诺肝素+维生素K拮抗剂(VKA)、或者安慰剂。这些研究旨在分析治疗后出现DVT、PE复发症状或死亡的患者人数。

研究结果显示，拜瑞妥在治疗DVT和PE方面与依诺肝素+VKA联合用药同样有效。在接受拜瑞妥治疗的患者中，出现了DVT或PE复发症状的患者比例约为2.1%，依诺肝素+VKA联合治疗组约为1.8%~3%。此外，第三项临床研究结果表明，延长拜瑞妥的治疗时间可以降低DVT和PE的复发风险。在接受拜瑞妥治疗的患者中，出现了DVT或PE复发症状的患者比例约为1.3%，而安慰剂组约为7.1%。

观察到的拜瑞妥主要不良反应是出血，与其他抗凝血药物类似。

与美国市场上的其他口服抗凝剂不同，只有拜瑞妥属于Ⅹa因子抑制剂。服用拜瑞妥的患者无需接受常规血液监测。

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ST LOUIS (MD Consult) - On November 2, 2012, the US Food and Drug Administration (FDA) and Janssen Pharmaceuticals announced that the oral anticoagulant Xarelto (rivaroxaban) has been approved for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE after initial treatment. Xarelto was previously approved to reduce the risk of DVT and PE after knee- or hip-replacement surgery, and to reduce the risk of stroke in persons with nonvalvular atrial fibrillation.

The safety and effectiveness of Xarelto for the new indications were evaluated in 3 clinical studies. A total of 9478 patients with DVT or PE were randomly assigned to receive Xarelto, a combination of enoxaparin and a vitamin K antagonist (VKA), or placebo. The studies were designed to measure the number of patients who experienced recurrent symptoms of DVT, PE, or death after receiving treatment.

Results of the studies showed that the use of Xarelto was as effective as the enoxaparin and VKA combination for treating DVT and PE. About 2.1% of patients treated with Xarelto compared with 1.8% to 3% of patients treated with the enoxaparin and VKA combination experienced a recurrent DVT or PE. Additionally, results from a third study showed extended Xarelto treatment reduced the risk of recurrent DVT and PE. About 1.3% of patients treated with Xarelto compared with 7.1% of patients who received placebo experienced a recurrent DVT or PE.

The major adverse effect observed with Xarelto use was bleeding, similar to other anticoagulant medications.

Unlike other oral anticoagulants available in the United States, only Xarelto is a factor Xa inhibitor. Routine blood monitoring is not required for patients receiving Xarelto.