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. 2015 Jan 22;12(3):223-33.
doi: 10.7150/ijms.10656. eCollection 2015.

Association between statin use and cancer: data mining of a spontaneous reporting database and a claims database

Mai Fujimoto  1 , Tomoya Higuchi  1 , Kouichi Hosomi  1 , Mitsutaka Takada  1
Affiliations

Association between statin use and cancer: data mining of a spontaneous reporting database and a claims database

Mai Fujimoto et al. Int J Med Sci. .

Abstract

Purpose: In recent years, the potential risk of cancer associated with statin use has been a focus of much interest. However, it remains uncertain whether statin therapy is associated with cancer risk. To examine the association between statin use and the risk of cancer, we conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and a large organized database of claims constructed by a database vendor (The Japan Medical Data Center Co., Ltd, Tokyo, Japan [JMDC]).

Methods: Relevant reports in the FAERS, which included data from the first quarter of 2004 through the end of 2012, were identified and analyzed. The reporting odds ratio (ROR) was used to detect spontaneous report signals and was calculated using the case/non-case method. Additionally, signals were detected via the information component (IC) using the IC025 metric. Furthermore, event sequence symmetry analysis (ESSA) was applied to identify the risk of cancer following treatment with statins over the period January 2005 to July 2013.

Results: In the FAERS database analyses, significant signals for colorectal cancer and pancreatic cancer were found for statins as a class. In the ESSA, significant associations between statin use and colorectal cancer and pancreatic cancer were found, with adjusted sequence ratios (95% confidence intervals) of 1.20 (1.08-1.34) and 1.31 (1.13-1.53), respectively, at an interval of 48 months.

Conclusions: Multi-methodological approaches using different algorithms and databases suggest that statin use is associated with an increased risk for colorectal cancer and pancreatic cancer.

Keywords: FAERS database; cancer risk; statin use.

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Conflict of interest statement

Competing Interests: Mai Fujimoto, Tomoya Higuchi, Kouichi Hosomi, and Mitsutaka Takada, have no conflicts of interest that are directly relevant to the content of this study.

References

    1. Shepherd J, Cobbe SM, Ford I. et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. The New England journal of medicine. 1995;333:1301–1307. - PubMed
    1. Taylor F, Huffman MD, Macedo AF. et al. Statins for the primary prevention of cardiovascular disease. The Cochrane database of systematic reviews. 2013;1:CD004816. - PMC - PubMed
    1. NCEP. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143–3421. - PubMed
    1. Keyomarsi K, Sandoval L, Band V. et al. Synchronization of tumor and normal cells from G1 to multiple cell cycles by lovastatin. Cancer research. 1991;51:3602–3609. - PubMed
    1. Wong WW, Dimitroulakos J, Minden MD. et al. HMG-CoA reductase inhibitors and the malignant cell: the statin family of drugs as triggers of tumor-specific apoptosis. Leukemia. 2002;16:508–519. - PubMed

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