| アブストラクト | BACKGROUND: Angioedema (AE) rarely occurs as a potentially life-threatening adverse drug reaction (ADR) to angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). The aim of the present study was to investigate non-genetic association factors with ACEi-/ARB-induced angioedema in the European ADR database EudraVigilance and the database of the vARIANCE study. METHODS: The cohort of the vARIANCE study comprised 114 patients who suffered from ACEi- or ARB-induced angioedema. In addition, 171 angioedema reports and 4650 reports on other ADRs of ACEi/ARB were identified in the ADR database EudraVigilance with the latter serving as a reference group. Odds ratios were calculated and a logistic regression analysis was performed using angioedema versus reference reports. RESULTS: Increased age, smoking, allergies and a history of previous angioedema were identified as associated factors for ACEi-/ARB-induced angioedema. In most patients, the swelling affected the face, lips and tongue. In the vARIANCE study, about 70% of angioedema occurred after 1 year of treatment. For one in two patients in the vARIANCE study (84.2% with ACEi treatment) and one in three patients from the EudraVigilance reports (59.6% with ARB treatment), the angioedema resulted in hospitalization. CONCLUSIONS: We found small to moderate associations with certain individual patient-related factors in this pharmaco-epidemiological study. As a future perspective, combining non-genetic association factors with corresponding genetic data might provide an option to compose stronger and individual risk scores. |
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| 投稿者 | Dubrall, Diana; Branding, Nora L; Mathey, Carina M; Weber, Anna M; Steffens, Michael; Below, Maike; Schmid, Matthias; Wedi, Bettina; Wieczorek, Dorothea; Amann, Philipp M; Loffler, Harald; Koch, Lukas; Schoffl, Clemens; Dickel, Heinrich; Ganjuur, Nomun; Hornung, Thorsten; Buhl, Timo; Aygoren-Pursun, Emel; Wurpts, Gerda; Greve, Jens; Nothen, Markus M; Forstner, Andreas J; Sachs, Bernhardt |
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| 組織名 | Institute for Medical Biometry, Informatics and Epidemiology, University Hospital;of Bonn, Bonn, Germany.;Research Division, Federal Institute of Drugs and Medical Devices (BfArM), Bonn,;Germany.;Institute of Human Genetics, University of Bonn, School of Medicine and;University Hospital Bonn, Bonn, Germany.;Central Research Institute for Ambulatory Health Care in Germany, Berlin,;Klinik fur Dermatologie, Allergologie und Venerologie, Medizinische Hochschule;Hannover, Hannover, Germany.;Klinik fur Dermatologie, Allergologie und Phlebologie, SLK-Kliniken Heilbronn,;Heilbronn, Germany.;Department of Medicine, Faculty of Medicine and Dentistry, Danube Private;University, Krems, Austria.;Department of Dermatology and Venereology, Medical University of Graz, Graz,;Austria.;Department of Dermatology, Venereology and Allergology, St. Josef Hospital,;University Medical Center, Ruhr University Bochum, Bochum, Germany.;Zentrum fur Hauterkrankungen, Universitatsklinikum Bonn, Bonn, Germany.;Klinik fur Dermatologie, Venerologie und Allergologie, Universitatsmedizin;Gottingen, Gottingen, Germany.;Department of Pediatrics, Goethe University Frankfurt, Frankfurt, Germany.;Klinik fur Dermatologie und Allergologie - Hautklinik, Universitatsklinik der;RWTH Aachen, Aachen, Germany.;Department of Otorhinolaryngology-Head and Neck Surgery, Ulm University Medical;Center, Ulm, Germany.;Institute of Neuroscience and Medicine (INM-1), Research Center Julich, Julich,;Department for Dermatology and Allergy, University Hospital RWTH Aachen, Aachen, |
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