Cardiac failure in patients treated with azacitidine, a pyrimidine analogue: Case reports and disproportionality analyses in Vigibase

Autor: Vincent Servant, Arnaud Pigneux, Yohann Bohbot, Nathan Mottal, Bernard Bégaud, Noel Milpied, Aude Berroneau, Emilien Bilion, Pierre Fenaux, Ghada Miremont-Salamé, Sophie Dimicoli-Salazar, Justine Perino, Hélène Théophile, Pierre Poustis, Aude Charbonnier, Kamel Laribi, Claire Calmettes
Přispěvatelé: Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Rok vydání: 2020
Předmět:
Male
Cardiac function curve
medicine.medical_specialty
Databases
Factual
MedDRA
Azacitidine
Angiotensin-Converting Enzyme Inhibitors
Transplantation
Autologous
030226 pharmacology & pharmacy
Ventricular Function
Left
Angiotensin Receptor Antagonists
Pharmacovigilance
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
030212 general & internal medicine
Aged
Retrospective Studies
Heart Failure
PharmacoEpi-Drugs
Pharmacology
business.industry
Hematopoietic Stem Cell Transplantation
Stroke Volume
Original Articles
Odds ratio
Middle Aged
medicine.disease
Confidence interval
3. Good health
Pharmaceutical Preparations
Heart failure
Female
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
business
Adverse drug reaction
medicine.drug
Zdroj: British Journal of Clinical Pharmacology
British Journal of Clinical Pharmacology, Wiley, In press, 86 (5), pp.991-998. ⟨10.1111/bcp.14211⟩
Br J Clin Pharmacol
ISSN: 1365-2125
0306-5251
DOI: 10.1111/bcp.14211
Popis: 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, 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 cardiac failure and cardiac failure acute. The reported odds ratio (ROR) and its 95% 2-sided confidence interval was computed by comparing the proportion of CF reports with the suspected drug (AZA) and the proportion of reports of the same adverse drug reaction with all other suspected drugs in the database during the same period. Results In the 4 case reports, all patients presented a cardiovascular history. In 1 patient, CF recurred after AZA re-challenge. The pharmacovigilance analysis in Vigibase retrieved 307 ICSRs of CF (SMQ) with AZA. Significant disproportionality signals associated with AZA were identified by using the SMQ cardiac failure (ROR 1.3) and the preferred terms cardiac failure (ROR 5.1) and cardiac failure acute (ROR 23.2). Conclusion 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.
Databáze: OpenAIRE
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