アブストラクト | 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): 1.49-1.781.25, 95% CI: 1.19-1.32and 1.59, 95% CI: 1.47-1.72 respectively), which all had positive signals for 'blood creatinine increased' and 'glomerular filtration rate decreased.' The median TTO of ARF onset was 57, 36, and 85 days for olaparib, niraparib, and rucaparib, respectively. The proportions of deaths, life-threatening events, and hospitalization adverse events (AEs) associated with ARF werewas 4.27%, 3.57%, and 19.80%, 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 AEs 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. Elevated creatinine levels and decreased glomerular filtration rates were associated with olaparib, niraparib, and rucaparib. More emphasis should be given to PARPis-related ARF due to the high proportion of serious AEs and delayed adverse reactions. |
組織名 | 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.;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.;Department of Comprehensive Oncology, National Cancer Center, National Clinical |