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Drug Safety

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01.06.2014 | Original Research Article

Association of Statin Use with Sleep Disturbances: Data Mining of a Spontaneous Reporting Database and a Prescription Database

verfasst von: Mitsutaka Takada, Mai Fujimoto, Kohei Yamazaki, Masashi Takamoto, Kouichi Hosomi

Erschienen in: Drug Safety | Ausgabe 6/2014

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Abstract

Background

Particular interest has been generated regarding the possible influence of statin use on sleep quality. However, no conclusive evidence exists that a particular statin is more likely to be associated with sleep disturbances versus others. It remains uncertain whether different statins produce different risks for sleep disturbance.

Objective

To examine the association between statin use and the risk of sleep disturbances, we conducted data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and a large organized database of prescriptions constructed by a database vendor (Japan Medical Information Research Institute, Inc. Japan).

Methods

Relevant reports in the FAERS were identified and analyzed. Data from the first quarter of 2004 through the end of 2013 were included in this study. The reporting odds ratio (ROR) was used to detect spontaneous report signals, calculated using the case/non-case method. For the ROR, a signal was detected if the lower limit of 95 % two-sided confidence interval (95 % CI) was >1. Additionally, signal detection using the IC was conducted using the IC025 metric, a lower limit of the 95 % CI of the IC, where a signal is detected if the IC025 value exceeds 0. In addition, symmetry analysis was used to identify the risk of insomnia after using statins over the period of January 2006 to August 2013.

Results

In the analyses of the FAERS database, significant signals for sleep disturbances including disturbances in initiating and maintaining sleep, sleep disorders NEC, sleeping disorders due to a general medical condition, and parasomnias were found. In the prescription sequence symmetry analysis, a significant association between statin use and hypnotic drug use was found, with adjusted sequence ratios of 1.14 (1.03–1.26), 1.20 (1.11–1.29), and 1.18 (1.11–1.25) at intervals of 91, 182, and 365 days, respectively.

Conclusion

Multi-methodological approaches using different algorithms and databases strongly suggest that statin use is associated with an increased risk for sleep disturbances including insomnia.

MedDRA^®, the Medical Dictionary for Regulatory Activities terminology, is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA^® trademark is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on behalf of the ICH.

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Titel: Association of Statin Use with Sleep Disturbances: Data Mining of a Spontaneous Reporting Database and a Prescription Database
verfasst von: Mitsutaka Takada
Mai Fujimoto
Kohei Yamazaki
Masashi Takamoto
Kouichi Hosomi
Publikationsdatum: 01.06.2014
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 6/2014
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-014-0163-x

Springer Medizin

Abstract

Background

Objective

Methods

Results

Conclusion

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