| アブストラクト | Background/Objectives: Digoxin, a positive inotropic agent with a narrow therapeutic window, is used in heart failure but carries toxicity risks. This study aims to characterize the profile of digoxin-associated adverse drug reactions reported in the EudraVigilance database, focusing on drug-drug interactions, dosing errors, and off-label use. Methods: Descriptive and disproportionality analyses were performed on Individual Case Safety Reports (ICSRs) until 25 January 2026. Digoxin was compared with other inotropic agents by calculating the Reporting Odds Ratio and 95% confidence intervals. Results: Digoxin recorded 11,426 ICSRs, with a predominance in patients aged 65-85 years (46.4%) and over 85 years (25.1%). Higher reporting probabilities were identified for the terms "Drug interaction" and "Overdose" compared to other inotropes. Fatal outcomes were reported in 19 cases related to drug interactions and 41 cases related to overdose. Consistent disproportionality signals were found for gastrointestinal, renal, and nervous system disorders. Off-label use was reported in 0.8% of cases and was associated with unfavorable clinical outcomes. Risks are exacerbated by polypharmacy and renal decline in elderly patients. Conclusions: Digoxin toxicity and cardiac complications are the primary drivers of reported morbidity. This risk profile highlights the need for the rigorous clinical monitoring, precise dose adjustments and heightened vigilance regarding drug-drug interactions. |
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| ジャーナル名 | Journal of clinical medicine |
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| Pubmed追加日 | 2026/8/13 |
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| 投稿者 | Fiat, Emilia Sorina; Stoicescu, Laurentiu; Popa Ilie, Ioana Rada; Vonica, Razvan Constantin; Butuca, Anca; Dobrea, Carmen Maximiliana; Frum, Adina; Morgovan, Claudiu; Batar, Florina; Solomon, Crina Cristina; Gligor, Felicia Gabriela |
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| 組織名 | Doctoral School, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169;Sibiu, Romania.;Department of Cardiology, County Clinical Emergency Hospital, 550245 Sibiu,;Romania.;Department of Cardiology, Vth Medical Clinic, Faculty of Medicine, "Iuliu;Hatieganu" University of Medicine and Pharmacy, 400139 Cluj-Napoca, Romania.;Department of Endocrinology, Faculty of Medicine, "Iuliu Hatieganu" University of;Medicine and Pharmacy, 3-5 Louis Pasteur Street, 400349 Cluj-Napoca, Romania.;Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu,;550169 Sibiu, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42590087/ |
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