| アブストラクト | INTRODUCTION: The incidence of clozapine-associated myocarditis varies by country. These variations were explored in VigiBase, the World Health Organization's global database which has >25 million spontaneously reported adverse drug reaction (ADR) reports from 145 national drug agencies. METHODS: On January 15, 2021, a search of VigiBase since inception focused on myocarditis in clozapine patients. The 3572 individual reports were studied using the standard VigiBase logarithmic measure of disproportionality called information component (IC). The IC measures the disproportionality between the expected and the reported rates. After duplicates were eliminated there were 3274 different patients with myocarditis studied in logistic regression models. RESULTS: The first case was published in 1980 but since 1993 the VigiBase clozapine-myocarditis IC has been significant; moreover, currently it is very strong (IC=6.0, IC(005)-IC(995)=5.9-6.1) and statistically significantly different from other antipsychotics. Of the 3274 different patients with myocarditis, 43.4% were non-serious cases, 51.8% were serious but non-fatal, and 4.8% were fatal. More than half (1621/3274) of the reports came from Australia, of which 69.2% were non-serious, 27.7% serious but non-fatal, and 3.1% fatal. Asian countries contributed only 41 cases. CONCLUSIONS: In pharmacovigilance studies, confounding factors may explain statistical associations, but the strength and robustness of these results are compatible with the hypothesis that myocarditis is definitively associated with early clozapine treatment (84% [1309/1560] and 5% [82/1560] in the first and second months). Myocarditis reports from Australia are over-represented to a major degree. Asian countries may be underreporting myocarditis to their drug agencies. |
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| 組織名 | Department of Internal Medicine, Dermatology and Psychiatry, School of Medicine,;Instituto Universitario de Neurociencias (IUNE), University of La Laguna, Canary;Islands, Spain.;Department of Physical Medicine and Pharmacology, School of Medicine, Universidad;de La Laguna, Canary Islands, Spain; Hospital Universitario de Canarias,;Tenerife, Spain.;Laboratory of Clinical Psychopharmacology & The National Clinical Research Centre;for Mental Disorders & Beijing Key Lab of Mental Disorders, Beijing Anding;Hospital, Capital Medical University, Beijing, China; Department of Psychiatry,;The National Clinical Research Centre for Mental Disorders & Beijing Key Lab of;Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia,;Beijing Anding Hospital, Capital Medical University, Beijing, China.;Mental Health Research Center, Eastern State Hospital, Lexington, KY, USA;;Psychiatry and Neurosciences Research Group (CTS-549), Institute of;Neurosciences, University of Granada, Granada, Spain; 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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