Epidemiology, Worldwide Safety Strategy, Pfizer Inc., New York, NY, USA.
Drug Saf. 2011 Dec 1;34(12):1125-49. doi: 10.2165/11594170-000000000-00000.
In the adjuvant setting, the third-generation aromatase inhibitors (AIs) anastrozole, letrozole and exemestane are recommended at some point during treatment, either in the upfront, switch after tamoxifen or extended treatment setting after tamoxifen in postmenopausal patients with hormone receptor-positive early breast cancer. AIs have demonstrated superior disease-free survival and overall benefit-to-risk profiles compared with tamoxifen. Potential adverse events, including cardiovascular (CV) side effects, should be considered in the long-term management of patients undergoing treatment with AIs. AIs reduce estrogen levels by inhibiting the aromatase enzyme, thus reducing the levels of circulating estrogen. This further reduction in estrogen levels may potentially increase the risk of developing CV disease. This systematic review evaluated published clinical data for changes in plasma lipoproteins and ischaemic CV events during adjuvant therapy with AIs in patients with hormone receptor-positive early breast cancer. The electronic databases MEDLINE, EMBASE, Derwent Drug File and BIOSIS were searched to identify English-language articles published from January 1998 to 15 April 2011 that reported data on AIs and plasma lipoproteins and/or ischaemic CV events. Overall, available data did not show any definitive patterns or suggest an unfavourable effect of AIs on plasma lipoproteins from baseline to follow-up assessment in patients with hormone receptor-positive early breast cancer. Changes that occurred in plasma lipoproteins were observed soon after initiation of AI therapy and generally remained stable throughout the studies. Available data do not support a substantial risk of ischaemic CV events associated with adjuvant AI therapy; however, studies with longer follow-up are required to better characterize the CV profile of AIs.
在辅助治疗中,第三代芳香化酶抑制剂(AIs)阿那曲唑、来曲唑和依西美坦在绝经后激素受体阳性早期乳腺癌患者中,无论在初始治疗、他莫昔芬后转换治疗还是他莫昔芬后延长治疗中,都建议在治疗过程中的某个时间点使用。与他莫昔芬相比,AIs 已被证明具有更优的无病生存和整体获益风险比。在长期管理接受 AIs 治疗的患者时,应考虑潜在的不良反应,包括心血管(CV)副作用。AIs 通过抑制芳香化酶来降低雌激素水平,从而降低循环雌激素水平。这种雌激素水平的进一步降低可能会增加发生 CV 疾病的风险。本系统评价评估了发表的临床数据,以了解在激素受体阳性早期乳腺癌患者的辅助治疗中使用 AIs 时,血浆脂蛋白和缺血性 CV 事件的变化。检索了 MEDLINE、EMBASE、德温特药物档案和 BIOSIS 电子数据库,以确定 1998 年 1 月至 2011 年 4 月 15 日期间发表的报告了关于 AIs 和血浆脂蛋白和/或缺血性 CV 事件数据的英文文章。总体而言,现有数据并未显示出任何明确的模式,也没有表明 AIs 对激素受体阳性早期乳腺癌患者从基线到随访评估时的血浆脂蛋白有不利影响。在开始 AI 治疗后不久观察到了血浆脂蛋白的变化,并且在整个研究中通常保持稳定。现有数据不支持与辅助 AI 治疗相关的缺血性 CV 事件的实质性风险;但是,需要进行更长时间随访的研究来更好地描述 AIs 的 CV 特征。