PARP inhibitor-related acute renal failure: a real-world study based on the FDA adverse event reporting system database.

Ren, Xiayang; Sun, Ping; Wang, Yanfeng

Ren, Xiayang; Sun, Ping; Wang, Yanfeng.

Afiliación

Ren X; Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Sun P; Department of Cancer Prevention, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Wang Y; Department of Comprehensive Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Expert Opin Drug Saf ; : 1-9, 2024 Jul 08.

Article en En | MEDLINE | ID: mdl-38967020

ABSTRACT

ABSTRACT

BACKGROUND:

Current clinical trial data on PARP inhibitors (PARPis)-related acute renal failure (ARF) are not entirely representative of real-world situations. Therefore, in this study, the US Food and Drug Administration Adverse Event Reporting System (FAERS) was used to evaluate PARPis-related ARF. RESEARCH DESIGN AND

METHODS:

Data were obtained from 1 January 2015, to 30 September 2023. ARF event reports were analyzed based on four algorithms. The time-to-onset (TTO) and clinical outcomes of PARPis-associated ARF were assessed.

RESULTS:

The total included cases were 2726. Significant signals were observed for olaparib, niraparib, and rucaparib (reporting odds ratio (ROR) 1.62, 95% confidence interval (CI) 1.49-1.78, 1.25, 95% CI 1.19-1.32 and 1.59, 95% CI 1.47-1.72 respectively). The median TTO of ARF onset was 57, 36, and 85 days for olaparib, niraparib, and rucaparib, respectively. The proportion of deaths with olaparib (9.88%) was significantly higher than for niraparib (2.52%) and rucaparib (2.94%) (p < 0.005). The proportion of life-threatening adverse events associated with niraparib (4.89%) was significantly higher than for rucaparib (0.98%) (p < 0.005).

CONCLUSIONS:

ARF and PARPi were related, with the exception of talazoparib. More emphasis should be given to PARPis-related ARF due to the high proportion of serious AEs and delayed adverse reactions.

Palabras clave

FDA adverse event reporting system; PARP inhibitors; acute renal failure; adverse event; pharmacovigilance

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Expert Opin Drug Saf Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido

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