Takagi Tomohisa, Xu Linghua, Hoshi Masato, Arai Shoko
Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Access and Value, Outcome and Evidence, Pfizer Japan Inc., Shibuya City, Tokyo, Japan.
J Gastroenterol Hepatol. 2025 Feb;40(2):421-432. doi: 10.1111/jgh.16831. Epub 2024 Dec 12.
We conducted a retrospective study to identify incidence rates and potential risk factors of major adverse cardiac events (MACE) in Japanese patients with ulcerative colitis (UC), as existing data are scarce, inconsistent, and provide limited representation of the real-world situation of MACE in Japan.
We utilized administrative claims data, collected between January 2013 and December 2022, from Medical Data Vision, Japan. Patients (aged ≥ 20 years) diagnosed with UC within ± 1 month of the prescription date during the study period were included in the incident cohort. Exclusions comprised patients diagnosed with UC in the first 365 days or with myocardial infarction, heart failure, stroke, or other ischemic heart diseases within 30 days pre-index. The cumulative incidence rate of MACE was calculated using the Kaplan-Meier method. Multivariate Cox regression models were used to calculate hazard ratios (HRs) for all relevant potential risk factors.
Of 11 407 patients in the incident cohort, 91 (0.8%) experienced incident MACE. Over 120 months, the cumulative incidence rate of MACE was 2.86% (95% confidence interval [CI]: 1.89-4.32). Significant HRs (95% CI) were found for age category (≥ 65 years) (4.557 [2.786-7.452]), diabetes (1.709 [1.030-2.835]), and atrial fibrillation (AF) (2.759 [1.188-6.405]) (all p < 0.05). Patients with a history of stroke showed numerically increased risk (1.871 [0.508-6.886]) of MACE.
The cumulative incidence rate of MACE was 2.86% over 120 months. Age, comorbidities of diabetes and AF, and history of stroke were the major risk factors for MACE in Japanese UC patients.
我们开展了一项回顾性研究，以确定日本溃疡性结肠炎（UC）患者发生主要不良心脏事件（MACE）的发生率及潜在风险因素，因为现有数据稀缺、不一致，且对日本MACE的实际情况代表性有限。
我们使用了日本医疗数据愿景公司在2013年1月至2022年12月期间收集的行政索赔数据。研究期间，在处方日期前后±1个月内被诊断为UC的患者（年龄≥20岁）被纳入发病队列。排除标准包括在最初365天内被诊断为UC的患者，或在索引前30天内患有心肌梗死、心力衰竭、中风或其他缺血性心脏病的患者。使用Kaplan-Meier方法计算MACE的累积发生率。多变量Cox回归模型用于计算所有相关潜在风险因素的风险比（HR）。
在发病队列的11407名患者中，91名（0.8%）发生了新发MACE。在120个月期间，MACE的累积发生率为2.86%（95%置信区间[CI]：1.89-4.32）。在年龄组（≥65岁）（4.557[2.786-7.452]）、糖尿病（1.709[1.030-2.835]）和心房颤动（AF）（2.759[1.188-6.405]）方面发现了显著的HR（95%CI）（所有p<0.05）。有中风病史的患者发生MACE的风险在数值上有所增加（1.871[0.508-6.886]）。
在120个月期间，MACE的累积发生率为2.86%。年龄、糖尿病和AF合并症以及中风病史是日本UC患者发生MACE的主要风险因素。
