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1000 Titel
  • Angioedemas associated with renin-angiotensin system blocking drugs: Comparative analysis of spontaneous adverse drug reaction reports
1000 Autor/in
  1. Dubrall, Diana |
  2. Schmid, Matthias |
  3. Stingl, Julia Carolin |
  4. Sachs, Bernhardt |
1000 Erscheinungsjahr 2020
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2020-03-26
1000 Erschienen in
1000 Quellenangabe
  • 15(3):e0230632.
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2020
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1371/journal.pone.0230632 |
1000 Ergänzendes Material
  • https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0230632#sec036 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • INTRODUCTION: Angioedema is a subcutaneous swelling typically affecting the face, larynx or pharynx. It is a known adverse drug reaction (ADR) of ACE inhibitors (ACEi), angiotensin-II-receptor blockers (ARBs) and aliskiren (renin inhibitor). Several studies have reported pathophysiological mechanisms and risk factors of ACEi-associated angioedemas, whereas little is known for ARBs and aliskiren. The aim of the study was to analyze comparatively ACEi versus ARBs and aliskiren angioedema reports contained in the European ADR database EudraVigilance with regard to reported risk factors and clinical phenotypes. METHODS: All spontaneous angioedema reports received between 01/2010-06/2017 reporting either an ACEi, ARB, or aliskiren as "suspected/interacting" drug were identified using the Standardized MedDRA Query "angioedema (narrow)". In order to perform a comparative analysis, odds ratios (ORs) were calculated for angioedema reports of ACEi (n = 3.194) versus ARBs (n = 687) and aliskiren (n = 162). RESULTS: More patients with a history of allergy were included in angioedema reports of ARBs (6.8%) and aliskiren (13.6%) versus ACEi (4.3%). "Urticaria" as an ADR was reported more frequently in angioedema reports of ARBs (18.5%) and aliskiren (9.0%) versus ACEi (5.0%). ACEi-associated angioedemas were more often designated as "life-threatening" compared to ARBs (OR 2.2 [1.6–2.9]) and aliskiren-associated angioedemas (OR 14.2 (3.5–57.4). Concomitant therapy with mTOR inhibitors (OR 4.3 [1.0–17.9]) and fibrinolytics (OR 7.8 [1.1–57.2]) was reported more often in ACEi versus ARBs angioedema reports. CONCLUSION: The reported clinical phenotypes differed between ACEi versus ARBs and aliskiren angioedema reports. Differences between the patient populations as observed in our study or differences with regard to underlying pathomechanisms could account for this finding. Due to the methodological limitations of spontaneous reporting systems, we cannot draw a firm conclusion in this regard. Hence, further research is necessary to confirm our observation and elucidate the underyling causes.
1000 Sacherschließung
lokal Drug administration
lokal Malignant tumors
lokal Urticaria
lokal Allergies
lokal Diabetes mellitus
lokal Tongue
lokal Adverse reactions
lokal Pruritus
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-8763-051X|https://frl.publisso.de/adhoc/uri/U2NobWlkLCBNYXR0aGlhcw==|https://frl.publisso.de/adhoc/uri/U3RpbmdsLCBKdWxpYSBDYXJvbGlu|https://frl.publisso.de/adhoc/uri/U2FjaHMsIEJlcm5oYXJkdA==
1000 Label
1000 Förderer
  1. Federal Institute for Drugs and Medical Devices (BfArM) |
  2. Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE) |
  3. University Hospital of Bonn |
1000 Fördernummer
  1. V-16703/68502/2016–2020
  2. V-16703/68502/2016–2020
  3. -
1000 Förderprogramm
  1. -
  2. -
  3. -
1000 Dateien
  1. Angioedemas associated with renin-angiotensin system blocking drugs
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Federal Institute for Drugs and Medical Devices (BfArM) |
    1000 Förderprogramm -
    1000 Fördernummer V-16703/68502/2016–2020
  2. 1000 joinedFunding-child
    1000 Förderer Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE) |
    1000 Förderprogramm -
    1000 Fördernummer V-16703/68502/2016–2020
  3. 1000 joinedFunding-child
    1000 Förderer University Hospital of Bonn |
    1000 Förderprogramm -
    1000 Fördernummer -
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6419468.rdf
1000 Erstellt am 2020-03-27T09:19:30.347+0100
1000 Erstellt von 281
1000 beschreibt frl:6419468
1000 Bearbeitet von 122
1000 Zuletzt bearbeitet Mon Mar 30 14:17:15 CEST 2020
1000 Objekt bearb. Mon Mar 30 14:16:57 CEST 2020
1000 Vgl. frl:6419468
1000 Oai Id
  1. oai:frl.publisso.de:frl:6419468 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

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