Sakata Yukinori, Matsuoka Toshiyuki, Ohashi Satoshi, Koga Tadashi, Toyoda Tetsumi, Ishii Mika
Clinical Planning and Development Department, Eisai Co., Ltd., 4-6-10, Koishikawa, Bunkyo-ku, Tokyo, 112-8088, Japan.
Clinical Study Support, Inc., Daiei Bldg, 2F, 1-11-20 Nishiki, Naka-ku, Nagoya, 460-0003, Japan.
Drugs Real World Outcomes. 2019 Mar;6(1):27-35. doi: 10.1007/s40801-019-0150-8.
To understand the extent to which a large-scale healthcare claims database (DB) captures the safety profile of eribulin mesylate (Halaven, Eisai Co., Ltd., Japan), we compared patient characteristics, drug use, and adverse events (AEs) between data for patients treated with eribulin retrieved from a DB and data for metastatic breast cancer patients from a conventional prospective post-marketing surveillance (PMS).
We descriptively summarized patient characteristics and AEs of 551 and 951 patients retrieved from DB and PMS, respectively, during 2011‒2013. Using 2814 patient data from the DB during 2011‒2016, the drug use and AE incidence over time were assessed.
In both datasets, 99.8% were females, and the mean age was 57.8 ± 10.7 years. The mean number of eribulin administration was 11.1 ± 10.9 and 10.1 ± 7.8 in DB and PMS, respectively. Although, overall, the difference in AE incidence between the two datasets was moderate, gaps were larger for nausea (DB: 73.32% vs. PMS: 15.77%), neutropenia (20.87% vs. 66.67%), stomatitis (37.39% vs. 10.94%), and alopecia (0.36% vs. 12.09%). During 2011‒2016, the observed incidence of anemia or pyrexia significantly decreased (trend test, p = 0.0009 for both).
Generally, patient characteristics, drug use, and AE incidence between the DB and PMS were comparable; however, AEs such as neutropenia may require defining based on the laboratory data to achieve more comparable results in DBs. Besides the usefulness of healthcare claims DBs for long-term assessments, they may also serve as a good complementary to PMS in the pharmacovigilance of eribulin.
为了解大型医疗保健索赔数据库（DB）在多大程度上反映了甲磺酸艾瑞布林（Halaven，日本卫材株式会社）的安全性概况，我们比较了从数据库中检索到的接受艾瑞布林治疗患者的数据与传统上市后前瞻性监测（PMS）中转移性乳腺癌患者的数据之间的患者特征、药物使用情况和不良事件（AE）。
我们分别对2011 - 2013年期间从数据库和PMS中检索到的551例和951例患者的患者特征和不良事件进行了描述性总结。利用2011 - 2016年期间数据库中的2814例患者数据，评估了随时间变化的药物使用情况和不良事件发生率。
在两个数据集中，99.8%为女性，平均年龄为57.8±10.7岁。数据库和PMS中艾瑞布林的平均给药次数分别为11.1±10.9次和10.1±7.8次。总体而言，两个数据集之间不良事件发生率的差异适中，但恶心（数据库：73.32% vs. PMS：15.77%）、中性粒细胞减少（20.87% vs. 66.67%）、口腔炎（37.39% vs. 10.94%）和脱发（0.36% vs. 12.09%）的差距较大。在2011 - 2016年期间，观察到的贫血或发热发生率显著下降（趋势检验，两者p = 0.0009）。
一般来说，数据库和PMS之间的患者特征、药物使用情况和不良事件发生率具有可比性；然而，中性粒细胞减少等不良事件可能需要根据实验室数据进行定义，以便在数据库中获得更具可比性的结果。除了医疗保健索赔数据库在长期评估中的有用性外，它们还可以作为艾瑞布林药物警戒中PMS的良好补充。
