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Abstract：
This study aimed to conduct a thorough analysis of fluid retention-associated adverse events (AEs) associated with BCR::ABL inhibitors.
A retrospective pharmacovigilance study.
Food and Drug Administration Adverse Event Reporting System (FAERS) database for BCR::ABL inhibitors was searched from 1 January 2004 to 30 September 2021.
Reporting OR (ROR) and 95% CI were used to detect the signals. ROR was calculated by dividing the odds of fluid retention event reporting for the target drug by the odds of fluid retention event reporting for all other drugs. The signal was considered positive if the lower limit of 95% CI of ROR was >1. The analysis was run only considering coupled fluid retention events/BCR::ABL inhibitors with at least three cases.
A total of 97 823 reports were identified in FAERS. Imatinib had the most fluid retention signals, followed by dasatinib and nilotinib, while bosutinib and ponatinib had fewer signals. Periorbital oedema (ROR=24.931, 95% CI 22.404 to 27.743), chylothorax (ROR=161.427, 95% CI 125.835 to 207.085), nipple swelling (ROR=48.796, 95% CI 26.270 to 90.636), chylothorax (ROR=35.798, 95% CI 14.791 to 86.642) and gallbladder oedema (ROR=77.996, 95% CI 38.286 to 158.893) were the strongest signals detected for imatinib, dasatinib, nilotinib, bosutinib and ponatinib, respectively. Pleural effusion, pericardial effusion and pulmonary oedema were detected for all BCR::ABL inhibitors, with dasatinib having the highest RORs for pleural effusion (ROR=37.424, 95% CI 35.715 to 39.216), pericardial effusion (ROR=14.146, 95% CI 12.649 to 15.819) and pulmonary oedema (ROR=11.217, 95% CI 10.303 to 12.213). Patients aged ≥65 years using dasatinib, imatinib, nilotinib or bosutinib had higher RORs for pleural effusion, pericardial effusion and pulmonary oedema. Patients aged ≥65 years and females using imatinib had higher RORs for periorbital oedema, generalised oedema and face oedema.
This pharmacovigilance study serves as a clinical reminder to physicians to be more vigilant for fluid retention-associated AEs with BCR::ABL inhibitors.
A retrospective pharmacovigilance study.
Food and Drug Administration Adverse Event Reporting System (FAERS) database for BCR::ABL inhibitors was searched from 1 January 2004 to 30 September 2021.
Reporting OR (ROR) and 95% CI were used to detect the signals. ROR was calculated by dividing the odds of fluid retention event reporting for the target drug by the odds of fluid retention event reporting for all other drugs. The signal was considered positive if the lower limit of 95% CI of ROR was >1. The analysis was run only considering coupled fluid retention events/BCR::ABL inhibitors with at least three cases.
A total of 97 823 reports were identified in FAERS. Imatinib had the most fluid retention signals, followed by dasatinib and nilotinib, while bosutinib and ponatinib had fewer signals. Periorbital oedema (ROR=24.931, 95% CI 22.404 to 27.743), chylothorax (ROR=161.427, 95% CI 125.835 to 207.085), nipple swelling (ROR=48.796, 95% CI 26.270 to 90.636), chylothorax (ROR=35.798, 95% CI 14.791 to 86.642) and gallbladder oedema (ROR=77.996, 95% CI 38.286 to 158.893) were the strongest signals detected for imatinib, dasatinib, nilotinib, bosutinib and ponatinib, respectively. Pleural effusion, pericardial effusion and pulmonary oedema were detected for all BCR::ABL inhibitors, with dasatinib having the highest RORs for pleural effusion (ROR=37.424, 95% CI 35.715 to 39.216), pericardial effusion (ROR=14.146, 95% CI 12.649 to 15.819) and pulmonary oedema (ROR=11.217, 95% CI 10.303 to 12.213). Patients aged ≥65 years using dasatinib, imatinib, nilotinib or bosutinib had higher RORs for pleural effusion, pericardial effusion and pulmonary oedema. Patients aged ≥65 years and females using imatinib had higher RORs for periorbital oedema, generalised oedema and face oedema.
This pharmacovigilance study serves as a clinical reminder to physicians to be more vigilant for fluid retention-associated AEs with BCR::ABL inhibitors.
摘要：
目的：本研究旨在对与BCR::ABL抑制剂相关的液体潴留相关不良事件（AE）进行全面分析。
方法：回顾性药物警戒研究。
方法：从2004年1月1日至2021年9月30日检索BCR::ABL抑制剂的食品和药物管理局不良事件报告系统（FAERS）数据库。
方法：使用报告OR（ROR）和95％CI检测信号。通过将目标药物的液体潴留事件报告的几率除以所有其他药物的液体潴留事件报告的几率来计算ROR。如果ROR的95%CI的下限>1,则该信号被认为是阳性的。仅考虑结合的流体滞留事件/BCR::ABL抑制剂与至少三个病例进行分析。
结果：FAERS共发现97823份报告。伊马替尼的体液潴留信号最多，其次是达沙替尼和尼罗替尼，而博舒替尼和普纳替尼的信号较少。眶周水肿（ROR=24.931，95%CI22.404至27.743），乳糜胸（ROR=161.427，95%CI125.835至207.085），乳头肿胀（ROR=48.796，95％CI26.270至90.636），乳糜胸(ROR=35.798,95%CI14.791至86.642)和胆囊水肿(ROR=77.996,95%CI38.286至158.893)是伊马替尼检测到的最强信号,达沙替尼,尼洛替尼,博舒替尼和普纳替尼，分别。胸腔积液,所有BCR均检测到心包积液和肺水肿：：ABL抑制剂，达沙替尼治疗胸腔积液的ROR最高(ROR=37.424,95%CI35.715~39.216),心包积液(ROR=14.146,95%CI12.649~15.819)和肺水肿(ROR=11.217,95%CI10.303~12.213)。年龄≥65岁的患者使用达沙替尼，伊马替尼,尼洛替尼或博舒替尼对胸腔积液的ROR较高，心包积液和肺水肿。年龄≥65岁的患者和使用伊马替尼的女性对眶周水肿的ROR较高，全身水肿和面部水肿。
结论：这项药物警戒研究作为临床提醒，医生要更加警惕BCR::ABL抑制剂引起的液体潴留相关不良事件。
方法：回顾性药物警戒研究。
方法：从2004年1月1日至2021年9月30日检索BCR::ABL抑制剂的食品和药物管理局不良事件报告系统（FAERS）数据库。
方法：使用报告OR（ROR）和95％CI检测信号。通过将目标药物的液体潴留事件报告的几率除以所有其他药物的液体潴留事件报告的几率来计算ROR。如果ROR的95%CI的下限>1,则该信号被认为是阳性的。仅考虑结合的流体滞留事件/BCR::ABL抑制剂与至少三个病例进行分析。
结果：FAERS共发现97823份报告。伊马替尼的体液潴留信号最多，其次是达沙替尼和尼罗替尼，而博舒替尼和普纳替尼的信号较少。眶周水肿（ROR=24.931，95%CI22.404至27.743），乳糜胸（ROR=161.427，95%CI125.835至207.085），乳头肿胀（ROR=48.796，95％CI26.270至90.636），乳糜胸(ROR=35.798,95%CI14.791至86.642)和胆囊水肿(ROR=77.996,95%CI38.286至158.893)是伊马替尼检测到的最强信号,达沙替尼,尼洛替尼,博舒替尼和普纳替尼，分别。胸腔积液,所有BCR均检测到心包积液和肺水肿：：ABL抑制剂，达沙替尼治疗胸腔积液的ROR最高(ROR=37.424,95%CI35.715~39.216),心包积液(ROR=14.146,95%CI12.649~15.819)和肺水肿(ROR=11.217,95%CI10.303~12.213)。年龄≥65岁的患者使用达沙替尼，伊马替尼,尼洛替尼或博舒替尼对胸腔积液的ROR较高，心包积液和肺水肿。年龄≥65岁的患者和使用伊马替尼的女性对眶周水肿的ROR较高，全身水肿和面部水肿。
结论：这项药物警戒研究作为临床提醒，医生要更加警惕BCR::ABL抑制剂引起的液体潴留相关不良事件。
