Author(s): Fujimoto M, Higuchi T, Hosomi K, Takada M
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Abstract OBJECTIVE: The efficacy and safety of statins have been studied in a number of clinical trials and epidemiological studies. In recent years, the Medicine and Healthcare Products Regulatory Agency (MHRA) has assessed the evidence available on the following adverse reactions associated with the use of statins: sleep disturbances, memory loss, micturition disorders (problems with urination), sexual disturbances, depression, and interstitial pneumopathy. However, the association between statin use and the risk of these adverse reactions remains unclear. To examine the association between statin use and the risk of lower urinary tract symptoms (LUTS) or the disorder causing LUTS, we carried out data mining using a prescription database. METHODS: A large organized database of prescriptions constructed by a database vendor was used in the study. Symmetry analysis was used to identify the risk of LUTS after using statins over the period January 2006 to August 2013. Statin use in combination with drugs administered for storage LUTS was examined by prescription sequence symmetry analysis (PSSA). RESULTS: A significant association between statins and drugs for storage LUTS was found, with adjusted sequence ratios (ASRs) of 1.21 (95\% CI, 1.00 - 1.46), 1.19 (95\% CI, 1.04 - 1.38), and 1.17 (95\% CI, 1.05 - 1.30) for intervals of 91, 182, and 365 days, respectively. In the analyses of individual statins, significant associations were found only for pravastatin. Significant associations with individual drugs for storage LUTS were found for solifenacin succinate with ASRs of 1.36 (95\% CI, 1.02 - 1.81), 1.48 (95\% CI, 1.19 - 1.84), and 1.47 (95\% CI, 1.25 - 1.73) for intervals of 91, 182, and 365 days, for flavoxate hydrochloride with an ASR of 1.56 (95\% CI, 1.13 - 2.17) at an interval of 182 days, and for oxybutynin hydrochloride with ASRs of 2.06 (95\% CI, 1.11 - 3.94) and 1.71 (95\% CI, 1.09 - 2.72) at intervals of 182 and 365 days. Significant associations with gender were found only in females with ASRs of 1.25 (95\% CI, 1.04 - 1.51) and 1.23 (95\% CI, 1.07 - 1.41) at intervals of 182 and 365 days, respectively. CONCLUSIONS: Analysis of the prescription database showed significant association for storage LUTS in statin users.
This article was published in Int J Clin Pharmacol Ther
and referenced in Journal of Microbial & Biochemical Technology