Data Science Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Osaka.
Medical Affairs Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Osaka.
J Clin Psychopharmacol. 2024;44(4):378-385. doi: 10.1097/JCP.0000000000001880. Epub 2024 Jun 4.
This study aimed to assess the association between antipsychotic doses and the risk of tardive dyskinesia (TD) in clinical practice using a Japanese claims database from 2010 to 2020.
The study population included patients 15 years or older with a diagnosis record of schizophrenia, depression, or bipolar disorder who were prescribed antipsychotics. Using a case-control design, we categorized patients newly diagnosed with TD as cases, with corresponding 1:10 matching in the control group. The primary endpoint was the relative risk of TD in the >median dose and ≤median dose groups, as determined using conditional logistic regression analysis adjusted for age.
The analysis population included 58,452 patients, and the median daily antipsychotic dose was 75 mg/d of chlorpromazine equivalent (CPZE). Of these, 80 were identified as TD cases, and doses >75 mg/d were associated with a significantly increased risk of TD at the last prescription and the maximum dose, respectively, before the date of the first diagnosis of TD. Post-hoc analysis further showed a significant association between doses ≥300 mg/d and the risk of TD compared to doses ≤75 mg/d and doses >75 to <300 mg/d. Comparing ≥300 mg/d versus >75 to <300 mg/d, the odd ratios at the last prescription and maximum dose before the first diagnosis of TD were 3.40 and 3.50, respectively.
In the Japanese medical claims database of patients receiving relatively low doses of antipsychotics, doses >75 mg/d were associated with an increased risk of TD in a dose-dependent manner.
本研究旨在使用 2010 年至 2020 年日本的一项医保索赔数据库,评估抗精神病药剂量与迟发性运动障碍(TD)风险之间的关联。
研究人群包括年龄在 15 岁及以上、有精神分裂症、抑郁症或双相情感障碍诊断记录且接受抗精神病药物治疗的患者。采用病例对照设计,将新诊断为 TD 的患者归为病例组,以 1:10 的比例在对照组中进行匹配。主要终点为使用条件逻辑回归分析调整年龄后,>中位数剂量组和≤中位数剂量组的 TD 相对风险。
分析人群包括 58452 名患者,抗精神病药的中位日剂量为 75 毫克等效氯丙嗪(CPZE)。其中,80 例被诊断为 TD 病例,在最后一次处方和最大剂量前的 TD 首次诊断日期之前,剂量>75 毫克/天与 TD 风险显著增加相关。事后分析进一步显示,与剂量≤75 毫克/天和剂量>75 至<300 毫克/天相比,剂量≥300 毫克/天与 TD 风险之间存在显著关联。与剂量>75 至<300 毫克/天相比,最后一次处方和最大剂量前的比值比(OR)分别为 3.40 和 3.50。
在接受相对低剂量抗精神病药治疗的日本医保索赔数据库患者中,剂量>75 毫克/天与 TD 风险呈剂量依赖性增加相关。