| アブストラクト | PURPOSE: To characterize acute pancreatitis (AP) related to sodium glucose co-transporter 2 inhibitors and to investigate this relationship through disproportionality analysis in an international pharmacovigilance database. METHODS: We analyzed all AP reports for canagliflozin, dapagliflozin and/or empagliflozin from the WHOs Global adverse drug reactions database VigiBase(R) up to July 2019. We characterized the patients, reporters, and reactions, and we present the proportional reporting ratio (PRR) and information component (IC) for each of the gliflozins. AP cases were reports containing at least one of 11 previously selected preferred terms. Gliflozin exposure was considered for all reports with at least one gliflozin as suspected/ interacting drug. RESULTS: Of the 19 834 180 individual case safety reports in VigiBase, in 600 reports containing 618 AP group reactions, gliflozins were suspected/ interacting drugs. Men were affected in 52.3% of the cases and 59.6% of the patients were in the 45-64 years age group. The reporters were in 417 cases healthcare professionals. Most of the reactions were reported for canagliflozin (59.7%), followed by empagliflozin (21%) and dapagliflozin (19.2%) and were serious (98.6%). Most of the reactions' outcomes (84% of the patients) were favorable. Ketoacidosis was frequently associated with the AP (21.3%). Significant PRR and IC were found for pancreatitis and pancreatitis acute for all three gliflozins, pancreatitis necrotizing for canagliflozin and empagliflozin and pancreatitis relapsing for empagliflozin. CONCLUSIONS: Most of the AP cases were serious and with favorable outcome. We identified possible alternative causes for AP, like concomitant medication, hypertriglyceridemia, and cholelithiasis and a frequent association with ketoacidosis. We found a significant association between AP and the use of canagliflozin, dapagliflozin, and empagliflozin that would need further investigation. |
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| ジャーナル名 | Pharmacoepidemiology and drug safety |
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| 投稿日 | 2021/6/23 |
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| 投稿者 | Frent, Ioana; Bucsa, Camelia; Leucuta, Daniel; Farcas, Andreea; Mogosan, Cristina |
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| 組織名 | Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy,;"Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania.;Drug Information Research Center, "Iuliu Hatieganu" University of Medicine and;Pharmacy, Cluj-Napoca, Romania.;Department of Medical Informatics and Biostatistics, "Iuliu Hatieganu" University;of Medicine and Pharmacy, Cluj-Napoca, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34156119/ |
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