AIMS: Azacitidine (AZA), a pyrimidine analogue, is validated for high-risk myelodysplastic syndrome or low-blast acute myeloid leukaemia in unfit patients for more intensive treatment. This study assessed the putative link between cardiac failure (CF) and AZA exposure.
METHODS: Cases of CF in patients treated with AZA were retrospectively collected and described from several centres of the Groupe Francophone des Myelodysplasies. A description analysis and a disproportionality analysis using Vigibase(R), the WHO Global Individual Case Safety Reports (ICSRs) database, were conducted on ICSRs by the Standardized MedDRA Queries (SMQ broad) "cardiac failure" and by Preferred Terms (PTs) "cardiac failure" and "cardiac failure acute". The ROR and its 95% two-sided confidence interval (CI) was computed by comparing the proportion of cardiac failure reports with the suspected drug (AZA) and the proportion of reports of the same ADR with all other suspected drugs in the database during the same period.
RESULTS: In the four case reports, all patients presented a cardiovascular history. In one patient, CF recurred after AZA re-challenge. The pharmacovigilance analysis in Vigibase(R) retrieved 307 ICSRs of cardiac failure (SMQ) with AZA. Significant disproportionality signals associated with AZA were identified by using the SMQ "cardiac failure" (ROR 1.3) and the PTs "cardiac failure" (ROR 5.1) and "cardiac failure acute" (ROR 23.2).
CONCLUSIONS: This study points to the potential role of AZA in the occurrence of CF. Cardiac evaluation before AZA initiation and regular monitoring of cardiac function during AZA treatment should be performed in patients with a history of cardiovascular disease.
|投稿者||Perino, Justine; Mottal, Nathan; Bohbot, Yohann; Servant, Vincent; Berroneau, Aude; Poustis, Pierre; Fenaux, Pierre; Laribi, Kamel; Charbonnier, Aude; Bilion, Emilien; Calmettes, Claire; Begaud, Bernard; Pigneux, Arnaud; Milpied, Noel; Miremont-Salame, Ghada; Theophile, Helene; Dimicoli-Salazar, Sophie|
|組織名||CHU de Bordeaux, Pole de Sante Publique, Service de pharmacologie medicale,;Centre Regional de pharmacovigilance de Bordeaux, F-33000, Bordeaux, France.;CHU de Bordeaux, Service d'Hematologie Clinique et Therapie Cellulaire Bordeaux,;F-33000, Bordeaux, France.;CHU d'Amiens, Pole Coeur-Thorax-Vaisseaux, Departement de Cardiologie, Amiens;Cedex, France.;Pharmacie a Usage Interieur, CHU de Bordeaux, Pessac, France.;Service des soins intensifs cardiologiques Haut-Leveque (intensive care unit) 1,;avenue de Magellan, 33600, Pessac, France.;Service d'Hematologie Seniors, Hopital Saint Louis, Ass Pub Hop Paris and Paris 7;Universite Paris, France.;Service d'Hematologie, Centre Hospitalier du Mans, Le Mans, France.;Service d'Hematologie, Institut Paoli Calmettes, Marseille, France.;Univ. Bordeaux, Inserm, Bordeaux Population Health Research Centre, team;Pharmacoepidemiology, UMR, 1219, Bordeaux, France.|