Institute for Clinical Research and Health Policy Studies, Tufts Medical Center and Tufts University School of Medicine, 800 Washington St, Box #80, Boston, MA 02111USA; Molecular Cardiology Research Institute, Department of Medicine, Tufts Medical Center and Tufts University School of Medicine, 800 Washington St, Boston, MA 02111USA.
J Clin Lipidol. 2009 Apr;3(2):138-42. doi: 10.1016/j.jacl.2009.02.005. Epub 2009 Feb 11.
In the recently reported Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, the combination of ezetimibe/simvastatin (E/S) was associated with a significantly increased risk of cancer compared to placebo, causing widespread public concern.
We examined the rates of cancer adverse event reports filed with the US Food and Drug Administration (FDA) of patients on ezetimibe or E/S, and compared these to reports with other potent cholesterol-lowering drugs.
We tabulated all adverse event reports listing "cancer" or "malignancy" filed with the FDA (July 2004 to March 2008) of patients taking ezetimibe or E/S, and compared those to reports of patients taking simvastatin, atorvastatin, or rosuvastatin. We calculated rates for such reports per million prescriptions. A secondary analysis examined cancer reports as a proportion of all reported adverse events for each medication.
Prescriptions for all drugs totaled 559 million (approximately 52 and 55 million prescriptions of ezetimibe and E/S, respectively), and cancer adverse event reports totaled 2334. There were 2.9 and 1.3 cancer-associated adverse event reports per million ezetimibe or E/S prescriptions, respectively, compared to a range of 3.1 to 5.1 per million prescriptions for the other drugs. Findings were similar when only reports listing the drug as "suspect" were considered. The proportions of reports listing cancer relative to all adverse event reports were 2.0% and 1.9% for ezetimibe and E/S, respectively, compared to a range of 1.3% to 3.9% for the other drugs.
This large-scale post-marketing analysis of reported adverse events does not support that ezetimibe or E/S increase the risk of cancer.
在最近报道的辛伐他汀和依折麦布治疗主动脉瓣狭窄（SEAS）试验中，与安慰剂相比，依折麦布/辛伐他汀（E/S）联合使用会显著增加癌症风险，引起了广泛的公众关注。
我们检查了依折麦布或 E/S 治疗患者向美国食品和药物管理局（FDA）报告的癌症不良事件报告率，并将这些报告与其他强效降胆固醇药物的报告进行了比较。
我们整理了所有向 FDA 报告的列出“癌症”或“恶性肿瘤”的不良事件报告（2004 年 7 月至 2008 年 3 月），这些报告是服用依折麦布或 E/S 的患者，与服用辛伐他汀、阿托伐他汀或罗苏伐他汀的患者进行比较。我们计算了每百万处方的此类报告率。二次分析检查了每种药物的所有报告不良事件中癌症报告的比例。
所有药物的处方总数为 5.59 亿（依折麦布和 E/S 的处方数分别约为 5200 万和 5500 万），癌症不良事件报告总数为 2334 例。依折麦布或 E/S 每百万处方的癌症相关不良事件报告分别为 2.9 和 1.3，而其他药物的范围为 3.1 至 5.1。仅考虑将药物列为“可疑”的报告时，结果相似。列出癌症的报告与所有不良事件报告的比例分别为依折麦布和 E/S 的 2.0%和 1.9%，而其他药物的范围为 1.3%至 3.9%。
这项针对报告不良事件的大规模上市后分析不支持依折麦布或 E/S 会增加癌症风险。
