| 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): 1.49-1.78, 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. |
|---|
| ジャーナル名 | Expert opinion on drug safety |
|---|
| 投稿日 | 2024/7/5 |
|---|
| 投稿者 | Ren, Xiayang; Sun, Ping; Wang, Yanfeng |
|---|
| 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 |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38967020/ |
|---|
