Vo Thao T, Nelson Jeanenne J
Worldwide Epidemiology, GlaxoSmithKline, 5 Moore Drive, Mailstop 17.2124.2A, Research Triangle Park, Durham, NC 27709-3398, USA.
J Cancer Epidemiol. 2012;2012:529357. doi: 10.1155/2012/529357. Epub 2012 Apr 12.
Studies on cardiovascular safety in cancer patients treated with highly or moderately emetogenic chemotherapy (HEC or MEC), who may have taken the antiemetic, aprepitant, have been limited to clinical trials and postmarketing spontaneous reports. Our study explored background rates of cardiovascular disease (CVD) events among HEC- or MEC-treated cancer patients in a population-based setting to contextualize events seen in a new drug development program and to determine at a high level whether rates differed by aprepitant usage. Medical and pharmacy claims data from the 2005-2007 IMPACT National Benchmark Database were classified into emetogenic chemotherapy categories and CVD outcomes. Among 5827 HEC/MEC-treated patients, frequencies were highest for hypertension (16-21%) and composites of venous (7-12%) and arterial thromboembolic events (4-7%). Aprepitant users generally did not experience higher frequencies of events compared to nonusers. Our study serves as a useful benchmark of background CVD event rates in a population-based setting of cancer patients.
对于接受高致吐性或中致吐性化疗(HEC或MEC)且可能已服用止吐药阿瑞匹坦的癌症患者,有关其心血管安全性的研究仅限于临床试验和上市后自发报告。我们的研究在基于人群的环境中探讨了接受HEC或MEC治疗的癌症患者中心血管疾病(CVD)事件的背景发生率,以便将在新药开发项目中观察到的事件置于背景中,并在较高层面确定发生率是否因阿瑞匹坦的使用情况而异。将2005 - 2007年IMPACT国家基准数据库中的医疗和药房理赔数据分类为致吐性化疗类别和CVD结局。在5827例接受HEC/MEC治疗的患者中,高血压(16 - 21%)以及静脉(7 - 12%)和动脉血栓栓塞事件组合(4 - 7%)的发生率最高。与未使用者相比,阿瑞匹坦使用者通常并未经历更高频率的事件。我们的研究为基于人群的癌症患者环境中的背景CVD事件发生率提供了有用的基准。