Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
摘要：
■关于PARP抑制剂（PARPis）相关的急性肾衰竭（ARF）的当前临床试验数据并不完全代表现实世界的情况。因此,在这项研究中，美国食品和药物管理局不良事件报告系统（FAERS）用于评估PARPis相关的ARF。
■数据是从2015年1月1日至2023年9月30日获得的。基于四种算法分析ARF事件报告。评估PARPis相关ARF的发病时间（TTO）和临床结局。
■纳入病例总数为2726例。观察到奥拉帕尼的显著信号，尼拉帕利,和rucaparib（报告优势比（ROR）：1.62，95％置信区间（CI）：1.49-1.781.25，95％CI：1.19-1.32和1.59，95％CI：1.47-1.72），所有这些都有“血肌酐升高”和“肾小球滤过率降低”的阳性信号。奥拉帕尼的ARF发作的中位TTO为57、36和85天，尼拉帕利,和rucaparib,分别。死亡的比例，危及生命的事件,与ARF相关的住院不良事件（AE）为4.27%，3.57%,19.80%，分别。奥拉帕尼死亡比例(9.88%)显著高于尼拉帕尼(2.52%)和鲁卡帕尼(2.94%)(p<0.005)。与尼拉帕尼相关的危及生命的AE的比例（4.89％）显着高于rucaparib（0.98％）（p<0.005）。
■ARF和PARPi相关，除了talazoparib.肌酐水平升高和肾小球滤过率下降与奥拉帕尼有关，尼拉帕利,还有rucaparib.由于严重不良事件和延迟不良反应的比例较高，因此应更加重视PARPis相关的ARF。
■数据是从2015年1月1日至2023年9月30日获得的。基于四种算法分析ARF事件报告。评估PARPis相关ARF的发病时间（TTO）和临床结局。
■纳入病例总数为2726例。观察到奥拉帕尼的显著信号，尼拉帕利,和rucaparib（报告优势比（ROR）：1.62，95％置信区间（CI）：1.49-1.781.25，95％CI：1.19-1.32和1.59，95％CI：1.47-1.72），所有这些都有“血肌酐升高”和“肾小球滤过率降低”的阳性信号。奥拉帕尼的ARF发作的中位TTO为57、36和85天，尼拉帕利,和rucaparib,分别。死亡的比例，危及生命的事件,与ARF相关的住院不良事件（AE）为4.27%，3.57%,19.80%，分别。奥拉帕尼死亡比例(9.88%)显著高于尼拉帕尼(2.52%)和鲁卡帕尼(2.94%)(p<0.005)。与尼拉帕尼相关的危及生命的AE的比例（4.89％）显着高于rucaparib（0.98％）（p<0.005）。
■ARF和PARPi相关，除了talazoparib.肌酐水平升高和肾小球滤过率下降与奥拉帕尼有关，尼拉帕利,还有rucaparib.由于严重不良事件和延迟不良反应的比例较高，因此应更加重视PARPis相关的ARF。
