| アブストラクト | BACKGROUND: QT interval prolongations were described with citalopram and escitalopram. However, the effects of the other serotonin reuptake inhibitors (SRIs) remained discussed. In order to identify a putative signal with other SRIs, the present study investigates the reports of QT interval prolongation with SRIs in two pharmacovigilance databases (PVDB). METHODS: Two kinds of investigations were performed: (1) a comparative study in VigiBase(R), the WHO PVDB, where notifications of QT prolongation with six SRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) were selected. Cases with overdose or pregnancy were excluded. The relationship between the "suspected" SRI and occurrence of QT prolongation was assessed by calculating reporting odds ratio (ROR) in a case/non-case design. (2) A descriptive study of QT prolongation reports with citalopram and escitalopram in the French FPVD. RESULTS: In VigiBase(R), 855 notifications were identified (mean age 56.2 years, mainly women 73%). Among them, 172 (20.1%) were associated to escitalopram; 299 (35.0%), to citalopram; 186 (21.8%), to fluoxetine; 94 (11.0%), to sertraline; 66 (7.7%), to paroxetine; and 38 (4.4%) to fluvoxamine. A significant ROR value (higher than 1) was only found for citalopram (3.35 CI95% [2.90-3.87]) or escitalopram (2.50 [2.11-2.95]). In the FPVD, eight reports of QT prolongation were found with citalopram and 27 with escitalopram, mainly in women (77.1%) with a mean age of 73.2 years. In 23 cases (66%), SRIs were associated with other suspected drugs, mainly cardiotropic or psychotropic ones. Hypokalemia was associated in six patients. CONCLUSION: This study, performed in real conditions of life, shows a clear signal of QT prolongation with only two SRIs, citalopram and escitalopram, indicating that QT prolongation is not a SRI class effect. |
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| 投稿者 | Ojero-Senard, Ana; Benevent, Justine; Bondon-Guitton, Emmanuelle; Durrieu, Genevieve; Chebane, Leila; Araujo, Melanie; Montastruc, Francois; Montastruc, Jean-Louis |
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| 組織名 | Laboratoire de Pharmacologie Medicale et Clinique, Centre Midi-Pyrenees de;PharmacoVigilance, de Pharmacoepidemiologie et d'Informations sur le Medicament,;Pharmacopole Midi-Pyrenees, INSERM UMR 1027, CIC INSERM 1436, CHU et Faculte de;Medecine de Toulouse, Toulouse, France.;Medecine de Toulouse, Toulouse, France. jean-louis.montastruc@univ-tlse3.fr. |
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