PMID- 32891571 OWN - NLM STAT- MEDLINE DCOM- 20210628 LR - 20210628 IS - 2212-5353 (Electronic) IS - 2212-5345 (Linking) VI - 59 IP - 1 DP - 2021 Jan TI - Tolerability and safety of nintedanib in elderly patients with idiopathic pulmonary fibrosis. PG - 99-105 LID - S2212-5345(20)30119-2 [pii] LID - 10.1016/j.resinv.2020.08.003 [doi] AB - BACKGROUND: 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). METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. CI - Copyright (c) 2020 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved. FAU - Uchida, Yoshinori AU - Uchida Y AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: uchida@kanagawa-junko.jp. FAU - Ikeda, Satoshi AU - Ikeda S AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: isatoshi0112@gmail.com. FAU - Sekine, Akimasa AU - Sekine A AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: Akimasa.Sekine@gmail.com. FAU - Katano, Takuma AU - Katano T AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: katano@kanagawa-junko.jp. FAU - Tabata, Erina AU - Tabata E AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: e-tabata@kanagawa-junko.jp. FAU - Oda, Tsuneyuki AU - Oda T AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: odatsu@kanagawa-junko.jp. FAU - Okuda, Ryo AU - Okuda R AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: okuda@kanagawa-junko.jp. FAU - Kitamura, Hideya AU - Kitamura H AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: kitamura@kanagawa-junko.jp. FAU - Baba, Tomohisa AU - Baba T AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: baba@kanagawa-junko.jp. FAU - Komatsu, Shigeru AU - Komatsu S AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: komatsu-s@kanagawa-junko.jp. FAU - Ogura, Takashi AU - Ogura T AD - Kanagawa Cardiovascular and Respiratory Center, Department of Respiratory Medicine, Tomioka-Higashi 6-16-1, Kanazawa-ku, Yokohama, 236-0051, Japan. Electronic address: ogura@kanagawa-junko.jp. LA - eng PT - Journal Article DEP - 20200903 PL - Netherlands TA - Respir Investig JT - Respiratory investigation JID - 101581124 RN - 0 (Indoles) RN - G6HRD2P839 (nintedanib) SB - IM MH - Age Factors MH - Aged MH - Aged, 80 and over MH - Anorexia/chemically induced/epidemiology MH - Body Mass Index MH - Drug Tolerance MH - Female MH - Humans MH - Idiopathic Pulmonary Fibrosis/*drug therapy MH - Incidence MH - Indoles/*administration & dosage/*adverse effects MH - Male MH - Nausea/chemically induced/epidemiology MH - Retrospective Studies MH - Risk Factors MH - Safety MH - Time Factors MH - Vital Capacity MH - Withholding Treatment/*statistics & numerical data OTO - NOTNLM OT - Adverse event OT - Early termination OT - Elderly patients OT - Idiopathic pulmonary fibrosis OT - Nintedanib COIS- Conflict of Interest Y Uchida, A Sekine, E Tabata, T Oda, R Okuda, H Kitamura, and S Komatsu declare that no potential conflicts of interest exist with any company/organization whose products or services may be discussed in this article. S Ikeda, T Baba, and T Ogura received honoraria from Nippon Boehringer Ingelheim Co., Ltd, and T Ogura received honoraria from Shionogi Co. Ltd. EDAT- 2020/09/07 06:00 MHDA- 2021/06/29 06:00 CRDT- 2020/09/06 20:23 PHST- 2019/12/24 00:00 [received] PHST- 2020/07/29 00:00 [revised] PHST- 2020/08/16 00:00 [accepted] PHST- 2020/09/07 06:00 [pubmed] PHST- 2021/06/29 06:00 [medline] PHST- 2020/09/06 20:23 [entrez] AID - S2212-5345(20)30119-2 [pii] AID - 10.1016/j.resinv.2020.08.003 [doi] PST - ppublish SO - Respir Investig. 2021 Jan;59(1):99-105. doi: 10.1016/j.resinv.2020.08.003. Epub 2020 Sep 3.