| アブストラクト | BACKGROUND: Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs). OBJECTIVE: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health Organization's pharmacovigilance database. Two possibly opposing hypotheses could explain this disparity: 1) fewer reported fatal outcomes in other Western European countries mainly reflect underreporting to VigiBase, and 2) the higher number of UK reports reflects higher real relative mortality. METHODS: VigiBase reports from clozapine's introduction to December 31, 2022, were studied for ADRs and the top 10 causes of fatal outcomes. The UK was compared with 11 other top reporting Western countries (Germany, Denmark, France, Finland, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland). Nine countries (except Ireland and Switzerland) were compared after controlling for population and clozapine prescriptions. RESULTS: The UK accounted for 29 % of worldwide clozapine-related fatal outcomes, Germany 2 % and <1 % in each of the other countries. The nonspecific label "death" was the top cause in the world (46 %) and in the UK (33 %). "Pneumonia" was second in the world (8 %), the UK (12 %), Ireland (8 %) and Finland (14 %). Assuming that our corrections for population and clozapine use are correct, other countries underreported only 1-10 % of the UK clozapine fatal outcome number. CONCLUSIONS: Different Western European countries consistently underreport to VigiBase compared to the UK, but have different reporting/publishing styles for clozapine-related ADRs/fatal outcomes. Three Scandinavian registries suggest lives are saved as clozapine use increases, but this cannot be studied in pharmacovigilance databases. |
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| 組織名 | Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine,;University of La Laguna, Canary Islands, Spain; Instituto Universitario de;Neurociencia (IUNE), Universidad de La Laguna, San Cristobal de La Laguna, Spain.;Electronic address: ccuevas@ull.edu.es.;Department of Physical Medicine and Pharmacology, School of Medicine, Universidad;de La Laguna, Canary Islands, Spain; Hospital Universitario de Canarias,;Tenerife, Spain.;HLS Therapeutics, Toronto, Canada. Electronic address:;j.gross@hlstherapeutics.com.;Department of Child and Adolescent Psychiatry, Charite Universitatsmedizin,;Berlin, Germany; The Zucker Hillside Hospital, Psychiatry Research, Northwell;Health, Glen Oaks, NY, USA; Department of Psychiatry, Zucker School of Medicine;at Northwell/Hofstra, Hempstead, NY, USA. Electronic address:;CCorrell@northwell.edu.;Universite Bordeaux, Inserm, Bordeaux Population Health Research Center, Team;Pharmacoepidemiology, Bordeaux, France. Electronic address:;helene.verdoux@u-bordeaux.fr.;Department of Psychiatry, School of Medicine and Medical Science, University;College Dublin, Dublin, Ireland.; Department of Psychiatry, St Vincent's Hospital;Fairview, Dublin, Ireland; Department of Psychosis Studies, Institute of;Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London,;UK. Electronic address: john.lally1@ucd.ie.;Psychiatry Unit, Department of Health Sciences, University Magna Graecia of;Catanzaro, Catanzaro, Italy.;Mental Health Services Noord-Holland-Noord, Alkmaar, the Netherlands; Dutch;Clozapine Collaboration Group, Castricum, the Netherlands. Electronic address:;R.Schulte@ggz-nhn.nl.;Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway; Department;of Pharmacy, University of Oslo, Oslo, Norway. Electronic address:;espen.molden@farmasi.uio.no.;Department of Psychiatry, Complejo Hospitalario Universitario de Santiago,;Santiago de Compostela, Spain. Electronic address:;manuel.arrojo.romero@sergas.es.;Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska;Institutet, Stockholm, Sweden; Department of Clinical Sciences/Psychiatry, Umea;University, Umea, Sweden. Electronic address: adrian.desai.bostrom@ki.se.;The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks,;NY, USA; Department of Psychiatry, Zucker School of Medicine at;Northwell/Hofstra, Hempstead, NY, USA; Department of Psychiatry, Psychotherapy;and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich,;Switzerland.;Department of Psychiatry, University of Cambridge, Cambridge, UK,; Cambridgeshire;and Peterborough NHS Foundation Trust, Fulbourn Hospital, Fulbourn, Cambridge,;UK. Electronic address: ef280@cam.ac.uk.;Mental Health Research Center at Eastern State Hospital, Lexington, KY, USA;;Biomedical Research Centre in Mental Health Net (CIBERSAM), Santiago Apostol;Hospital, University of the Basque Country, Vitoria, Spain. Electronic address:;jdeleon@uky.edu. |
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