Department of Pharmacy, International University of Health and Welfare Hospital, Nasushiobara, Japan;
Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, International University of Health and Welfare, Nasushiobara, Japan.
In Vivo. 2023 May-Jun;37(3):1246-1252. doi: 10.21873/invivo.13201.
BACKGROUND/AIM: Lenalidomide (LND) is an oral antineoplastic agent used in the treatment of various malignant hematologic diseases, including multiple myeloma. Major adverse events of LND include myelosuppression, pneumonia, and thromboembolism. Thromboembolism is an adverse drug reaction (ADR) associated with poor outcomes, therefore anticoagulants are administered prophylactically. However, LND-induced thromboembolism has not been clearly characterized from clinical trials. The purpose of this study was to evaluate the incidence, timing, and outcome details of thromboembolism caused by LND using the JADER (Japanese Adverse Drug Event Report) database. PATIENTS AND METHODS: ADRs due to LND reported from April 2004 to March 2021 were selected. Data on thromboembolic adverse events were analyzed and relative risks were estimated using reported odds ratios (RORs) and 95% confidence intervals (CIs). In addition, the time of onset and outcome of thromboembolism were analyzed. RESULTS: There were 11,681 adverse events attributed to LND. Of these, 306 were thromboembolisms. The most frequently reported thrombosis with the highest ROR was deep vein thrombosis (DVT) (165 cases, ROR=7.12, 95%CI=6.09-8.33). The median onset of DVT (quartiles, 25-75%) was 80 (28-155) days. The parameter value (β) was 0.87 (0.76-0.99), suggesting the onset of DVT early in treatment. The prognosis of DVT due to LND was recovery and remission in 34% and 43% of patients, respectively, but 7.9% did not recover. CONCLUSION: DVT is the most frequent thromboembolism in LND, and early treatment is important.
背景/目的:来那度胺(LND)是一种用于治疗多种恶性血液病的口服抗肿瘤药物,包括多发性骨髓瘤。LND 的主要不良事件包括骨髓抑制、肺炎和血栓栓塞。血栓栓塞是一种与不良预后相关的药物不良反应(ADR),因此预防性使用抗凝剂。然而,LND 引起的血栓栓塞在临床试验中尚未得到明确描述。本研究旨在使用 JADER(日本药物不良反应报告)数据库评估 LND 引起的血栓栓塞的发生率、时间和结局细节。 患者和方法:选择 2004 年 4 月至 2021 年 3 月期间报告的 LND 引起的 ADR。分析血栓栓塞不良事件的数据,并使用报告的比值比(ROR)和 95%置信区间(CI)估计相对风险。此外,还分析了血栓栓塞的发病时间和结局。 结果:有 11681 例不良事件归因于 LND。其中 306 例为血栓栓塞。报告的血栓栓塞中,最常见的是深静脉血栓形成(DVT)(165 例,ROR=7.12,95%CI=6.09-8.33)。DVT 的中位发病时间(四分位距,25-75%)为 80(28-155)天。参数值(β)为 0.87(0.76-0.99),表明 DVT 在治疗早期发病。LND 引起的 DVT 的预后分别为 34%和 43%的患者恢复和缓解,但 7.9%的患者未恢复。 结论:DVT 是 LND 中最常见的血栓栓塞,早期治疗很重要。
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