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KMID : 0370220230670010015
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Yakhak Hoeji
2023 Volume.67 No. 1 p.15 ~ p.22
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Detecting Drug Interaction Signal of Concomitant Use of Warfarin and Statins Using Korea Adverse Event Reporting System Database
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Won Hee-Hyun
Choi Hyun-Young
Park Soo-Bin
Choi Nam-Kyong
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Abstract
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The increase in polypharmacy in elderly patients is recognized as a serious health, economic, and socialproblem. Warfarin and statins are commonly co-administered to cardiovascular disease patients. However, there is apotential risk of drug-drug interaction (DDI). The objective of this study was to detect signals of adverse events (AEs) forDDI after concomitant use of warfarin and statins using Korea adverse events reporting system (KAERS) database.
KAERS database from January 2016 to December 2020 was used. Omega (Ω) shrinkage measure model and Chi-squarestatistics model were used to calculate the criteria for detecting AEs signal resulting from concomitant use of warfarin andstatins. Three indices were used to define signals: Ω025 (frequentist) >0, Ω025 (Bayesian) >0, and ?>2. Detected signalswere compared with AEs listed on the drug label in Korea, Micromedex, and SIDER for warfarin and statins, respectively.
Twenty-seven AEs on reports of concomitant use were detected as signals. Of 27 detected signals, 11 signals, includingbreath odour not otherwise specified (NOS), depersonalization, gastrointestinal neoplasm NOS, pleural effusion, medicaldevice complication, menopausal symptoms, oedema cerebral, osteitis, prostatic hyperplasia, lipoma, and skin hypertrophy,were not listed on drug label. We identified signals for concomitant use of warfarin and statins. Careful monitoring andfurther pharmacoepidemiological studies of DDI associated with new signals using other databases are needed.
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KEYWORD
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Drug-drug interaction, Warfarin, Statins, KAERS Database
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