Revue d'epidemiologie et de sante publique · 2016
[Antiemetics and cardiac effects potentially linked to prolongation of the QT interval: Case/non-case analysis in the national pharmacovigilance database].
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Rochoy M, Auffret M, Béné J, Gautier S, Réseau français des centres régionaux de pharmacovigilance
Аннотация
OBJECTIVES: Observational retrospective studies have linked domperidone and prolonged QT interval, ventricular arrhythmias and risk of sudden death. Since then, antiemetic prescription was applied to other molecules (including metopimazine). The aim of this study was to evaluate the profile of adverse cardiac effects associated with QT prolongation for each antiemetic available in France.
METHODS: We conducted disproportionality analyses (case/non-case method), based on the observations recorded consecutively in the French national pharmacovigilance database between 2004 and 2013. Cases were defined by following MedDRA terms: prolongation of the QT interval, syncope, sudden death, cardiac arrest, ventricular arrhythmias including torsades de pointes; non-cases were other adverse events reported during the same period. We analyzed the presence of each antiemetic among cases and non-cases and measured the disproportionality by reporting odds ratios (ROR). We validate the assay with a positive control (methadone) and a negative control (acetaminophen).
RESULTS: We compared 2093 cases (94 with antiemetics) to 253,665 non-cases (7015 with antiemetics). Among antiemetics, adverse cardiac effects studied were more frequently found with notifications including domperidone (ROR=2.0, 95% CI=[1.3; 3.0]), ondansetron (ROR=1.8, 95% CI=[1.3; 2.6]) and granisetron (ROR=3.4, 95% CI=[1.5; 7.6]). Metopimazine was not statistically associated with that risk (ROR=2.0; 95% CI=[0.8; 4.8]).
CONCLUSION: We confirmed a risk of cardiac adverse event related to prolongation of the QT interval with domperidone and setrons. These results suggest caution when prescribing antiemetics and encourage systematic reporting of adverse cardiac effects observed with these molecules.
METHODS: We conducted disproportionality analyses (case/non-case method), based on the observations recorded consecutively in the French national pharmacovigilance database between 2004 and 2013. Cases were defined by following MedDRA terms: prolongation of the QT interval, syncope, sudden death, cardiac arrest, ventricular arrhythmias including torsades de pointes; non-cases were other adverse events reported during the same period. We analyzed the presence of each antiemetic among cases and non-cases and measured the disproportionality by reporting odds ratios (ROR). We validate the assay with a positive control (methadone) and a negative control (acetaminophen).
RESULTS: We compared 2093 cases (94 with antiemetics) to 253,665 non-cases (7015 with antiemetics). Among antiemetics, adverse cardiac effects studied were more frequently found with notifications including domperidone (ROR=2.0, 95% CI=[1.3; 3.0]), ondansetron (ROR=1.8, 95% CI=[1.3; 2.6]) and granisetron (ROR=3.4, 95% CI=[1.5; 7.6]). Metopimazine was not statistically associated with that risk (ROR=2.0; 95% CI=[0.8; 4.8]).
CONCLUSION: We confirmed a risk of cardiac adverse event related to prolongation of the QT interval with domperidone and setrons. These results suggest caution when prescribing antiemetics and encourage systematic reporting of adverse cardiac effects observed with these molecules.