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18 December 2018

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Int J Med Sci 2015; 12(3):223-233. doi:10.7150/ijms.10656

Research Paper

Association between Statin Use and Cancer: Data Mining of a Spontaneous Reporting Database and a Claims Database

Mai Fujimoto, Tomoya Higuchi, Kouichi Hosomi, Mitsutaka Takada

Division of Clinical Drug Informatics, School of Pharmacy, Kinki University, 3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan


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: statin use, cancer risk, FAERS database

This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) License. See for full terms and conditions.
How to cite this article:
Fujimoto M, Higuchi T, Hosomi K, Takada M. Association between Statin Use and Cancer: Data Mining of a Spontaneous Reporting Database and a Claims Database. Int J Med Sci 2015; 12(3):223-233. doi:10.7150/ijms.10656. Available from