Hospitalization for adverse events under abiraterone or enzalutamide exposure in real-world setting: a French population-based study on prostate cancer patients.

Safety profiles of abiraterone and enzalutamide mainly rely on phase III clinical trials. Our objective was to estimate the incidence rate ratio (IRR) for certain adverse events leading in real life to hospitalization (atrial fibrillation, acute heart failure, ischemic heart disease, acute kidney injury (AKI), ischemic stroke, torsade de pointe/QT interval prolongation, hepatitis, and seizure), comparing abiraterone to enzalutamide. We also set out to discuss previously identified safety signals.

Using the French National Health Insurance System database, all patients newly exposed to abiraterone or enzalutamide between 2013 and 2017 and followed until December 31st , 2018 were targeted. IRR for each event were estimated using a Poisson model in a sub-population of patients without contraindications or precautions for use for either treatment.

Among 11,534 new users of abiraterone and enzalutamide, AKI (IRR 1.42, 95% CI: 1.01-2.00), liver monitoring suggestive of hepatic damage (IRR 3.06, 95% CI: 2.66-3.53), and atrial fibrillation (IRR 1.12, 95% CI: 1.05-1.19) were significantly more often observed with abiraterone than with enzalutamide.

Our study provides knowledge on abiraterone and enzalutamide real-life safety profiles, especially for events leading to hospitalisation. Despite several limitations, including the lack of clinical data, the safety signal for AKI under abiraterone is in line with results of an analysis of the French pharmacovigilance database, which requires further specific investigations. Enlightening the clinicians' therapeutic choices for patients treated for prostate cancer, our study should lead to clinicians to be cautious in the use of abiraterone.

British journal of clinical pharmacology. 2021 Jul 05 [Epub ahead of print]

Lucie-Marie Scailteux, Fabien Despas, Frédéric Balusson, Boris Campillo-Gimenez, Romain Mathieu, Sébastien Vincendeau, André Happe, Emmanuel Nowak, Sandrine Kerbrat, Emmanuel Oger

Pharmacovigilance, Pharmacoepidemiology and Drug Information Centre, Department of Clinical Pharmacology, Rennes University Hospital, Rennes, France., Department of Clinical Pharmacology, Toulouse University Hospital, Toulouse, France., Univ Rennes, EA 7449 REPERES 'Pharmacoepidemiology and Health Services Research', Rennes, France., Eugène Marquis Comprehensive Cancer Regional Center, Rennes, France., Urology Department, Rennes University Hospital, Rennes, France., PEPS research consortium.

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