OBJECTIVE: The aim of this study was to describe the profile of adverse drug reactions (ADRs) observed with abiraterone and enzalutamide, based on cases registered in the French regional pharmacovigilance centres to identify potential pharmacovigilance signals.
METHODS: We extracted from the French pharmacovigilance database all cases of ADRs or drug interactions involving abiraterone or enzalutamide from the time they market authorization date until December 31st, 2017. Signal detection results have been transmitted by the French Agency for Health Products (ANSM). The data were compared with those of the risk management plans for each drug and the literature.
RESULTS: Among the 233 observations analyzed, nearly 62% involved abiraterone as a suspect drug and 38% involved enzalutamide; only 1 case involved both drugs. The ADRs profile is different between the drugs. Abiraterone is mostly associated with expected cardiac diseases (heart failure, and QT prolongation), expected with the drug. Also described, several cases of hepatotoxicity have been reported, however some cases with fatal outcome suggest that despite a follow-up of the liver function tests, it is difficult to anticipate this risk. Signals concerning acute renal failure and ischemic stroke have arisen. Enzalutamide is more particularly associated with various neurological disorders (convulsions, hallucinations, fatigue, and memory impairment) expected with the drug. While ischemic heart disease is also expected, signals of heart failure and atrial fibrillation have arisen. A potential hepatotoxicity of the molecule is discussed because of cases of cholestatic hepatitis.
CONCLUSION: The analysis of the French pharmacovigilance database cases allows to confirm an expected and monitored risk profile in the risk management plan for both drugs. Several signals have arisen, some of which will be investigated through a pharmacoepidemiology study.
|投稿者||Scailteux, Lucie-Marie; Lacroix, Clemence; Bergeron, Sandrine; Despas, Fabien; Sassier, Marion; Triquet, Louise; Picard, Sylvie; Oger, Emmanuel; Polard, Elisabeth|
|組織名||Centre regional de pharmacovigilance, pharmacoepidemiologie et information sur le;medicament, CHU de Rennes, rue Henri Le Guilloux, 35000 Rennes, France; EA 7449;REPERES, universite Rennes, 35000 Rennes, France. Electronic address:;email@example.com.;Service de pharmacologie clinique, centre regional de pharmacovigilance, Inserm,;institut de neuroscience des systemes UMR 1106, Aix Marseille universite, AP-HM,;13005 Marseille, France.;UMR-S1172, degenerative and vascular cognitive disorders, Lille neuroscience and;cognition, Inserm, CHU de Lille, universite Lille, 59000 Lille, France.;Service de pharmacologie medicale et clinique, Inserm 1027, facultes de medecine,;CHU, universite Paul-Sabatier, 31000 Toulouse, France.;medicament, CHU de Caen, 14000 Caen, France.;medicament, CHU de Rennes, rue Henri Le Guilloux, 35000 Rennes, France.;REPERES, universite Rennes, 35000 Rennes, France.|