Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan.
Respir Investig. 2021 Jan;59(1):99-105. doi: 10.1016/j.resinv.2020.08.003. Epub 2020 Sep 3.
In the phase III trial of nintedanib, only 10.8% of participants were aged ≥75 years. Here, we aimed to evaluate the tolerability and safety of nintedanib in elderly patients with idiopathic pulmonary fibrosis (IPF).
In total, 71 consecutive patients with (1) IPF, (2) age ≥75 years, and (3) newly prescribed nintedanib from September 2015 to April 2018 (elderly group) were retrospectively reviewed. Patient characteristics, treatment status, and adverse events (AEs) were compared between the elderly group and 126 patients with IPF, aged <75 years, with newly prescribed nintedanib during the same period (non-elderly group).
In the elderly group, 32 patients (46.4%) discontinued nintedanib within 6 months. Body size was significantly smaller, the incidence rates of anorexia and nausea were significantly higher, and early termination within 6 months were more common in the elderly than in the non-elderly group. In elderly patients, a univariate logistic regression analysis showed that body mass index (BMI) and percentage forced vital capacity (FVC) were risk factors for early termination (p = 0.02 and 0.03, respectively). A low initial nintedanib dose did not reduce the incidence of AEs and early termination rate in the elderly group.
In elderly patients with IPF, the incidence of early nintedanib termination was higher, and anorexia and nausea were common AEs compared with those in non-elderly IPF patients. Treatment was frequently discontinued in elderly patients with low BMI and FVC, and chest physicians should be aware that nintedanib therapy may result in early termination in these patients.
在尼达尼布的 III 期临床试验中，只有 10.8%的参与者年龄≥75 岁。在此，我们旨在评估尼达尼布在特发性肺纤维化（IPF）老年患者中的耐受性和安全性。
共回顾性分析了 71 例（1）IPF、（2）年龄≥75 岁、（3）2015 年 9 月至 2018 年 4 月期间新处方尼达尼布的患者（老年组）。比较了老年组与同期 126 例年龄<75 岁、新处方尼达尼布的 IPF 患者（非老年组）的患者特征、治疗状况和不良事件（AE）。
在老年组中，32 例（46.4%）患者在 6 个月内停用尼达尼布。老年组患者体型明显较小，厌食和恶心发生率明显较高，6 个月内提前终止治疗的情况更为常见。在老年患者中，单变量 logistic 回归分析显示，体重指数（BMI）和用力肺活量（FVC）百分比是提前终止治疗的危险因素（p=0.02 和 0.03）。在老年组中，初始尼达尼布低剂量并未降低 AE 的发生率和提前终止率。
在 IPF 老年患者中，尼达尼布提前终止治疗的发生率较高，厌食和恶心等 AE 较常见。BMI 和 FVC 低的老年患者治疗常被中断，胸部医师应注意，尼达尼布治疗可能导致这些患者提前终止治疗。
