Hashimoto Hiroyuki, Imai Shinobu, Yamashita Ryoka, Kiyomi Anna, Sugiura Munetoshi
Department of Drug Safety and Risk Management, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, 1432-1, Horinouchi, Hachioji, Tokyo, 192-0392, Japan.
Division of Pharmacoepidemiology, Department of Healthcare and Regulatory Sciences, Showa University School of Pharmacy, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan.
Drugs Real World Outcomes. 2024 Mar;11(1):109-116. doi: 10.1007/s40801-023-00401-2. Epub 2023 Nov 28.
Approximately a decade has passed since the addition of venous thromboembolism to the list of significant adverse reactions of antipsychotic drugs. However, only a few studies have investigated the relationship between antipsychotic use and venous thromboembolism in the Japanese population.
We aimed to evaluate the risk of recurrent venous thromboembolism in users of antipsychotic drugs and update the evidence on venous thromboembolism in the Japanese population.
A cross-sectional retrospective analysis of data from a large Japanese claims database, managed by Medical Data Vision Co. Ltd., was conducted. Adult patients who experienced venous thromboembolism between October 2014 and September 2018 in acute care hospitals were identified. The risk of recurrent venous thromboembolism was evaluated with logistic regression using demographic variables. The data of patients using antipsychotic drugs within specific therapeutic classes were also evaluated.
We included 8960 patients (mean age, 69 years; 59.2% female). Recurrent venous thromboembolism was observed in 686 patients (7.7%). The risk of recurrent venous thromboembolism was significantly higher in younger patients [< 65 years: reference; 65-74 years: odds ratio (OR) 0.81, 95% confidence interval (CI) 0.66-0.99, p = 0.04; ≥ 75 years: OR 0.77, 95% CI 0.64-0.94, p = 0.01], those with history of surgery (OR 1.39, 95% CI 1.18-1.65, p = 0.01), and anticoagulant users (OR 2.25, 95% CI 1.46-3.48, p = 0.01) and was significantly lower in the presence of comorbidities (OR 0.68, 95% CI 0.58-0.81, p< 0.01) and fractures (OR 0.49, 95% CI 0.26-0.94, p = 0.03). Long-term antipsychotic drug prescriptions (> 14 days) were associated with a higher risk of venous thromboembolism than short-term prescriptions (≤ 14 days) (OR 1.56, 95% CI 1.04-2.34, p = 0.03).
In patients with a history of venous thromboembolism, particular attention should be paid to recurrence in younger patients. If antipsychotic drugs are prescribed for > 14 days to patients with a history of venous thromboembolism, they should be administered carefully, guided by reported findings. Further evaluations using different databases or populations are required to generalize the findings of this study.
自将静脉血栓栓塞症列入抗精神病药物的重大不良反应清单以来，大约已经过去了十年。然而，只有少数研究调查了日本人群中抗精神病药物使用与静脉血栓栓塞症之间的关系。
我们旨在评估抗精神病药物使用者复发性静脉血栓栓塞症的风险，并更新日本人群中静脉血栓栓塞症的相关证据。
对由Medical Data Vision Co. Ltd.管理的大型日本索赔数据库中的数据进行横断面回顾性分析。确定了2014年10月至2018年9月在急性护理医院经历静脉血栓栓塞症的成年患者。使用逻辑回归分析人口统计学变量评估复发性静脉血栓栓塞症的风险。还评估了特定治疗类别中使用抗精神病药物患者的数据。
我们纳入了8960名患者（平均年龄69岁；59.2%为女性）。686名患者（7.7%）出现复发性静脉血栓栓塞症。年轻患者（<65岁：参考；65-74岁：比值比（OR）0.81，95%置信区间（CI）0.66-0.99，p = 0.04；≥75岁：OR 0.77，95%CI 0.64-0.94，p = 0.01）、有手术史的患者（OR 1.39，95%CI 1.18-1.65，p = 0.01）和使用抗凝剂的患者（OR 2.25，95%CI 1.46-3.48，p = 0.01）复发性静脉血栓栓塞症的风险显著更高，而合并症患者（OR 0.68，95%CI 0.58-0.81，p<0.01）和骨折患者（OR 0.49，95%CI 0.26-0.94，p = 0.03）的风险显著更低。长期抗精神病药物处方（>14天）比短期处方（≤14天）与静脉血栓栓塞症的风险更高相关（OR 1.56，95%CI 1.04-2.34，p = 0.03）。
有静脉血栓栓塞症病史患者，应特别关注年轻患者的复发情况。如果给有静脉血栓栓塞症病史的患者开具抗精神病药物超过14天，应根据报告结果谨慎给药。需要使用不同数据库或人群进行进一步评估，以推广本研究的结果。
