Prasugrel submitted for approval in US

　　2008年1月4日－日本东京 美国印第安纳州 印第安纳波利斯市讯

　　日本三共株式会社和美国礼来公司已经一起向美国食品和药品管理局(FDA)递交了新的抗血小板药物的上市应用申请，该药物主要针对已经行介入治疗的急性冠脉综合征（ACS）患者，如果获得批准，该药将以Effient为品牌名上市。

　　该申请是基于2007年11月召开的美国心脏病学会年会（AHA）上公布的TRITON-TIMI 38结果提出的，该研究结果显示与氯吡格雷相比，prasugrel能显著降低缺血事件，但是在计划行PCI治疗的ACS患者增加其主要出血并发症。亚组分析结果显示有几组人群发生出血并发症的危险性较高；研究者建议这些患者最好不用或者减少prasugrel的用量，而其他患者则是获益大于出血风险。

　　如获得FDA批准，prasugrel可能要禁用于有中风史的患者，而对于老年人和体重较低的患者则推荐减量使用。

　　（阜外心血管病医院  高立建  编译）

    （来源：www.theheart.org）

Prasugrel submitted for approval in US

January 4, 2008  Sue Hughes

Tokyo, Japan and Indianapolis, IN - Daiichi Sankyo and Eli Lilly have submitted a new drug application for the antiplatelet drug prasugrel to the US FDA for the treatment of ACS patients who are managed with PCI. If approved for marketing, the brand name will be Effient.

The application is based on data from the TRITON-TIMI 38 trial, reported at last November’s American Heart Association meeting. The trial showed significantly reduced ischemic events compared with clopidogrel, but at the expense of an increase in major bleeding in ACS patients scheduled for PCI. Subgroup analysis identified several groups that were at higher risk of bleeding; the investigators suggested that these people should not take the drug or should take a lower dose. For the rest of the population, the benefit of prasugrel outweighed the risk, they said.

If approved, it appears likely that prasugrel would be contraindicated in patients with a previous stroke, and dose reductions would be recommended for the elderly and those of lower body weights.