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[Adverse drug reactions profiles for abiraterone and enzalutamide: A pharmacovigilance descriptive analysis]. | LitMetric

[Adverse drug reactions profiles for abiraterone and enzalutamide: A pharmacovigilance descriptive analysis].

Therapie

Centre régional de pharmacovigilance, pharmacoépidémiologie et information sur le médicament, CHU de Rennes, rue Henri Le Guilloux, 35000 Rennes, France; EA 7449 REPERES, université Rennes, 35000 Rennes, France.

Published: October 2021

AI Article Synopsis

  • This study investigates adverse drug reactions (ADRs) linked to the cancer medications abiraterone and enzalutamide, using data from French pharmacovigilance centers up to 2017.
  • Most ADRs (62%) were associated with abiraterone, showing risks like heart failure and liver toxicity, while enzalutamide was linked primarily to neurological issues and some heart conditions.
  • The findings support known risks for both drugs but also highlight new concerns, prompting further investigation into these signals through additional pharmacoepidemiology studies.

Article Abstract

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.

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Source
http://dx.doi.org/10.1016/j.therap.2020.12.012DOI Listing

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