Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, 113-0033, Japan.
BMC Cancer. 2023 Aug 11;23(1):745. doi: 10.1186/s12885-023-11201-w.
Rucaparib has been approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. However, the long-term safety of rucaparib in large sample population was unknown. The presented study aimed to evaluate rucaparib-associated adverse events (AEs) according to the real-world pharmacovigilance database.
Disproportionality analysis was conducted to assess the association between rucaparib and its AEs. Data were collected from the international pharmacovigilance database of US FDA Adverse Event Reporting System (FAERS) between January 2017 and June 2022. The characteristics of rucaparib-related AEs, and the onset time were further analyzed.
A total of 9,296,694 AE reports were recorded in the FAERS during the study period, among which 7,087 reports were associated with rucaparib. About 135 rucaparib-related AE signals in 15 system organ class (SOCs) were identified. The most common AEs included anaemia, thrombocytopenia, nausea, vomiting, fatigue, blood creatinine increase, alanine aminotransferase increase, and aspartate aminotransferase increase, which were listed in the label for rucaparib. Of note, 21 new and unexpected significant AEs that off-label were also found in our study, such as preferred term (PTs) of intestinal obstruction, gastrooesophageal reflux disease, blood iron decreased, dehydration, and hypersomnia. The median onset time of rucaparib-related AEs was 12 days (interquartile range [IQR] 1-62 days), and had early failure types.
Our study demonstrated potential new AEs of rucaparib, and further studies were expected to confirm the results.
鲁卡帕尼已被批准用于治疗复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌的成年患者。然而，大样本人群中鲁卡帕尼的长期安全性尚不清楚。本研究旨在根据真实世界的药物警戒数据库评估鲁卡帕尼相关不良事件（AE）。
采用比例失调分析评估鲁卡帕尼与 AE 之间的关联。数据来自美国 FDA 不良事件报告系统（FAERS）国际药物警戒数据库，时间范围为 2017 年 1 月至 2022 年 6 月。进一步分析了鲁卡帕尼相关 AE 的特征和发病时间。
研究期间 FAERS 共记录了 9296694 例 AE 报告，其中 7087 例与鲁卡帕尼相关。在 15 个系统器官类别（SOC）中确定了 135 个与鲁卡帕尼相关的 AE 信号。最常见的 AE 包括贫血、血小板减少、恶心、呕吐、疲劳、血肌酐升高、丙氨酸氨基转移酶升高和天冬氨酸氨基转移酶升高，这些都是鲁卡帕尼的标签内容。值得注意的是，我们的研究还发现了 21 种新的、意外的、无标签的严重 AE，如首选术语（PTs）的肠梗阻、胃食管反流病、血铁减少、脱水和嗜睡。鲁卡帕尼相关 AE 的中位发病时间为 12 天（四分位距[IQR] 1-62 天），具有早期失效类型。
本研究表明鲁卡帕尼存在潜在的新 AE，需要进一步研究来证实这些结果。
