| アブストラクト | BACKGROUND: It is unclear whether the s (-) form of esomeprazole (EPZ) has an improved safety profile when compared with its racemic form omeprazole (OPZ). We assessed the potential complications of these optical isomers when combined with cilostazol, clopidogrel, and prasugrel, which are frequently used concomitant medications. METHODS: Using two adverse event spontaneous reporting databases, Japanese Adverse Drug Event Report (JADER) and FDA Adverse Event Reporting System (FAERS), adverse event names for hemorrhage, venous/arterial embolization, and thrombus were obtained from the Medical Dictionary for Regulatory Activities. Reported odds ratios were calculated using a 2 x 2 contingency table, and a signal was considered present if the lower limit of the 95% confidence interval was >1. RESULTS: In combination with cilostazol, a hemorrhagic signal for OPZ in JADER and arterial emboli and thrombus signals for EPZ were detected in both databases. In combination with clopidogrel, OPZ showed arterial emboli and thrombus signals in JADER and venous/arterial emboli and thrombus signals in FAERS, while EPZ displayed arterial emboli and thrombus signals in FAERS. In contrast, when in combination with prasugrel, there were no adverse event signals in either database. CONCLUSION: This study has confirmed using big data, that EPZ, the optical isomer and racemic form of omeprazole, has the beneficial characteristics of being less sensitive to CYP, as was intended by its design. |
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| ジャーナル名 | Toxicology and applied pharmacology |
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| 投稿日 | 2023/7/24 |
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| 投稿者 | Neishi, Mami; Hamano, Hirofumi; Niimura, Takahiro; Denda, Masaya; Yagi, Kenta; Miyata, Koji; Lin, Tsung-Jen; Higashionna, Tsukasa; Goda, Mitsuhiro; Zamami, Yoshito; Ishizawa, Keisuke; Nawa, Hideki |
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| 組織名 | Faculty of Pharmacy, Department of Pharmacy, Shujitsu University, 1-6-1;Nishikawara, Nakaku, Okayama 703-8516, Japan.;Department of Pharmacy, Okayama University Hospital, 2-5-1 Shikata-cho, Kitaku,;Okayama 700-8558, Japan. Electronic address: hamano.hirofumi@okayama-u.ac.jp.;Department of Clinical Pharmacology and Therapeutics, Tokushima University;Graduate School of Biomedical Sciences, 2-50-1 Kuramoto-cho, Tokushima 770-8503,;Japan.;Clinical Research Center for Developmental Therapeutics, Tokushima University;Hospital, 2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan.;Department of Cell and Molecular Biology, Chang Gung University, No. 259, Wenhua;1st Rd, Guishan District, Taoyuan City, Taiwan.;Okayama 700-8558, Japan.;Department of Pharmacy, Tokushima University Hospital, 2-50-1 Kuramoto-cho,;Tokushima 770-8503, Japan.;Japan; Department of Pharmacy, Tokushima University Hospital, 2-50-1;Kuramoto-cho, Tokushima 770-8503, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37482254/ |
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