Journal of Pharmacovigilance

Abstract

Association of Statin Use with Storage Lower Urinary Tract Symptoms: Data Mining of Claims Database

Mai Fujimoto, Tomoya Higuchi, Kouichi Hosomi and Mitsutaka Takada

Background: It remains uncertain whether or not statin use is associated with development of micturition disorders. To examine the association between statin use and the risk of storage lower urinary tract symptoms (LUTS), data mining was performed on a claims database.

Methods: Symmetry analysis was carried out to identify the risk of storage LUTS after statin use during the period from January 2005 to December 2011. Statin use in combination with drugs for storage LUTS was examined by prescription sequence symmetry analysis. Likewise, event sequence symmetry analysis was undertaken to evaluate the association between statin use and the diagnosis of storage LUTS and overactive bladder (OAB).

Results: Significant associations of statin use with drugs for storage LUTS were found, with an adjusted sequence ratio (ASR) of 1.58 (1.08-2.33) at an interval of 6 months. In the analysis of drugs for OAB alone, significant associations were found, with ASRs of 1.82 (1.14-2.97) and 1.47 (1.06-2.04) at intervals of 6 and 12 months, respectively.In analyses of individual statins and drugs for OAB, a significant association was found for pravastatin, with an ASR of 2.66 (1.15-6.88) at an interval of 6 months, but not for other statins. Significant associations were found for statin users in analyses of diagnosis of OAB, with ASRs of 2.00 (1.18-3.50) and 1.58 (1.10-2.28) at intervals of 6 and 12 months.

Conclusion: Analysis of the claims database demonstrated that statins might be associated with a new onset of storage LUTS. Statin-associated storage LUTS should be monitored closely in clinical practice, and further studies are needed to confirm our findings and elucidate the mechanism for statin-associated storage LUTS.