| アブストラクト | Whether ibrutinib-related atrial fibrillation (IRAF) is a dose-dependent adverse drug reaction (ADR) and whether ibrutinib should be discontinued or dose-reduced in case of IRAF occurrence remains unknown. Using the World Health Organization individual case safety report pharmacovigilance database, VigiBase(R), we aimed to determine the association between ibrutinib dosing regimens and IRAF reporting. Ibrutinib daily dose was extracted from IRAF cases from VigiBase(R) and was divided into 5 ibrutinib dosing regimen (140-280-420-560 and >560 mg/day). Disproportionality analysis was used to evaluate the association between IRAF reporting and ibrutinib daily dose, through logistic regression. Single term deletions produced the ibrutinib daily dose global p-value. Then, a multivariable adjusted reporting odds-ratio with its 95% confidence interval was calculated for each ibrutinib dosing regimen, against the lowest dosing regimen (140 mg/day) as reference. A total of 1162 IRAF cases were identified in VigiBase(R) (n = 62 for ibrutinib 140 mg/day, 114 for ibrutinib 280 mg/day, 811 for ibrutinib 420 mg/day, 164 for ibrutinib 560 mg/day and 11 for ibrutinib >560 mg/day). After adjustment on several variables of interest, IRAF reporting was not significantly associated with ibrutinib dosing regimen (p = 0.09). Our results from Vigibase(R) do not support IRAF as a dose-dependent ADR (ClinicalTrial registration number: NCT06224452). |
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| 投稿者 | Alexandre, Joachim; Font, Jonaz; Angelique, Da-Silva; Delapierre, Baptiste; Damaj, Ghandi; Plane, Anne-Flore; Legallois, Damien; Milliez, Paul; Dolladille, Charles; Chretien, Basile |
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| 組織名 | Normandie Univ, UNICAEN, INSERM U1086 ANTICIPE, Biology-Research Building, Avenue;de la Cote de Nacre, F-14000, Caen, France. joachim.alexandre@unicaen.fr.;Caen-Normandy University Hospital, PICARO Cardio-Oncology Program, Department of;Pharmacology, Biology-Research Building, Avenue de la Cote de Nacre, F-14000,;Caen, France. joachim.alexandre@unicaen.fr.;de la Cote de Nacre, F-14000, Caen, France.;Caen-Normandy University Hospital, Department of Cardiology, Avenue de la Cote de;Nacre, F-14000, Caen, France.;Caen-Normandy University Hospital, PICARO Cardio-Oncology Program, Departments of;Pharmacology and Medical Oncology, Avenue de la Cote de Nacre, F-14000, Caen,;France.;Caen-Normandy University Hospital, Hematology Institute, Avenue de la Cote de;Cardiology, Avenue de la Cote de Nacre, F-14000, Caen, France.;Normandie Univ, UNICAEN, INSERM U1237 PhIND, GIP Cyceron, Boulevard Henri;Becquerel, F-14000, Caen, France.;Caen, France.;Caen-Normandy University Hospital, Centre Regional de PharmacoVigilance,;Department of Pharmacology, Biology-Research Building, Avenue de la Cote de |
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