| アブストラクト | BACKGROUND: Methimazole (MMI) and propylthiouracil (PTU) are commonly used for patients with thyrotoxicosis. Agranulocytosis and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is associated with high morbidity and mortality, requiring appropriate interventions. In this study, we compared adverse drug effects associated with MMI and PTU using a real-world large pharmacovigilance database. METHODS: We searched all Individual Case Safety Reports reported to be associated with MMI and PTU, from VigiBase between 1967 and June 2, 2021. We conducted disproportionality analysis (case/non-case analysis) to analyze the difference in reported adverse drug reactions (ADRs) between antithyroid drugs (case) and the entire database (non-cases). We further analyzed information for the cases of agranulocytosis and AAV. RESULTS: Among 11 632 cases of ADRs reported after MMI intake, agranulocytosis occurred in 1633 cases and AAV occurred in 41 cases. For 5055 cases of ADRs reported after PTU intake, agranulocytosis occurred in 459 cases and AAV occurred in 110 cases. Agranulocytosis occurred after a median of 28 days after PTU intake and 33 days after MMI intake. More than 95% of the agranulocytosis cases were classified as serious, but most of them (65.1% for PTU and 70.4% for MMI) were reported to have recovered after dechallenge actions; mostly drug withdrawal. AAV occurred after a median of 668 days after PTU intake, and 1162 days after MMI intake. CONCLUSIONS: This is a pharmacoepidemiological study investigating agranulocytosis and AAV caused by MMI and PTU. Through this research, we could provide more specific insights into a safe prescription of antithyroid drugs in a real-world setting. |
|---|
| 投稿者 | Han, Ji Yun; Lee, Jun Myong; Jung, Se Yong; Kim, Min Seo; Lee, Seung Won; Kronbichler, Andreas; Tizaoui, Kalthoum; Koyanagi, Ai; Kim, Eun Young; Song, Kyungchul; Chae, Hyun Wook; Yon, Dong Keon; Shin, Jae Il; Smith, Lee |
|---|
| 組織名 | Seoul National University Hospital, Seoul, Republic of Korea.;Department of Medicine, Yonsei University Wonju College of Medicine, Wonju,;Republic of Korea.;Division of Pediatric Cardiology, Department of Pediatrics, Yonsei University;College of Medicine, Seoul, Republic of Korea.;Samsung Advanced Institute for Health Sciences & Technology (SAIHST),;Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea.;Department of Precision Medicine, Sungkyunkwan University School of medicine,;Suwon, Republic of Korea.;Department of Internal Medicine IV, Nephrology and Hypertension, Medical;University Innsbruck, Innsbruck, Austria.;Department of Medicine, University of Cambridge, Cambridge, UK.;Laboratory of Biomedical Genomics and Oncogenetics, Institut Pasteur de Tunis,;University Tunis El Manar, Tunis, Tunisia.;Research and Development Unit, Parc Sanitari Sant Joan de Deu, Universitat de;Barcelona, Fundacio Sant Joan de Deu, CIBERSAM, Barcelona, Spain.;ICREA, Barcelona, Spain.;Instituto de Salud Carlos III, Centro de Investigacion Biomedica en Red de Salud;Mental (CIBERSAM), Madrid, Spain.;Evidence-Based Research Laboratory, Department of Clinical Pharmacy and;Pharmaceutical Care, College of Pharmacy, Chung-Ang University, Seoul, South;Korea.;Department of Pharmaceutical Industry, ChungAng University, Seoul, South Korea.;College of Pharmacy, Chung-Ang University, Seoul, South Korea.;Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic;of Korea.;Center for Digital Health, Medical Science Research Institute, Kyung Hee;University College of Medicine, Seoul, South Korea.;Severance Underwood Meta-Research Center, Institute of Convergence Science,;Yonsei University, Seoul, Republic of Korea.;Centre for Health, Performance and Wellbeing, Anglia Ruskin University,;Cambridge, CB1 1PT, UK. |
|---|
