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Tolerability of nintedanib-related diarrhea in patients with idiopathic pulmonary fibrosis.
Pulmonary Pharmacology & Therapeutics ( IF 3.2 ) Pub Date : 2020-03-20 , DOI: 10.1016/j.pupt.2020.101917
Yasutaka Hirasawa 1 , Mitsuhiro Abe 1 , Jiro Terada 1 , Masashi Sakayori 1 , Kenichi Suzuki 1 , Keiichiro Yoshioka 1 , Takeshi Kawasaki 1 , Kenji Tsushima 2 , Koichiro Tatsumi 1
Affiliation  

BACKGROUND Nintedanib is an important drug for the treatment of idiopathic pulmonary fibrosis (IPF). However, the drug is discontinued in some patients who present with diarrhea. In this study, we aimed to assess the drug continuation rate in patients who developed diarrhea during nintedanib therapy and to evaluate if antidiarrheal drugs or nintedanib dose reductions improved clinical tolerability and efficacy. METHODS Eighty-six patients with IPF were treated in our institution between December 2015 and March 2018. Among them, 50 patients who experienced nintedanib-related diarrhea were analyzed regarding tolerability and persistence rate. RESULTS In 50 patients who experienced nintedanib-related diarrhea, 26 (n = 11, without reduction and n = 15, with reduction) continuously received nintedanib. Meanwhile, the drug was discontinued in 24 patients (n = 13, without reduction and n = 11, with reduction). In 9 of 24 patients, the drug was discontinued due to diarrhea. The annual rate of decline in forced vital capacity and the duration of nintedanib administration were not significantly different between groups with and without dosage reduction. Moreover, 23, 13, 8, and 2 patients received 1, 2, 3, and 4 agents, respectively. Clostridium butyricum is a probiotic bacterium most commonly used as an antidiarrheal agent. In this study, it was used in 28 of 46 patients. The total durations of nintedanib administration differed significantly according to the number of antidiarrheal drugs taken: 853 ± 221 days, more than three agents; 424 ± 365 days, without an agent (p = 0.043); and 460 ± 142, one agent (p = 0.0003). CONCLUSIONS When diarrhea occurs within a year after using nintedanib, the dose reduction may be acceptable without affecting pulmonary function. Moreover, treatment with multiple antidiarrheals may be a practical option to maintain the use of nintedanib therapy compared with monotherapy and no therapy.

中文翻译:

Nintedanib相关性腹泻在特发性肺纤维化患者中的耐受性。

背景技术Nintedanib是用于治疗特发性肺纤维化(IPF)的重要药物。但是,某些出现腹泻的患者应停药。在这项研究中,我们旨在评估在nintedanib治疗期间出现腹泻的患者中的药物持续率,并评估抗腹泻药或nintedanib剂量减少是否能改善临床耐受性和疗效。方法2015年12月至2018年3月在本院接受治疗的86例IPF患者,其中分析了50例发生了与intedanib相关性腹泻的患者的耐受性和持续率。结果在50例发生nintedanib相关性腹泻的患者中,连续26例(n = 11,未降低,n = 15,具有降低),连续接受nintedanib。与此同时,在24例患者中停用了该药物(n = 13,无降低,n = 11,有降低)。24名患者中有9名因腹泻而停药。在有或没有减少剂量的组之间,强迫肺活量的年下降率和使用nintedanib的持续时间没有显着差异。此外,有23、13、8和2位患者分别接受了1、2、3和4种药物治疗。丁酸梭菌是最常用作止泻剂的益生菌。在这项研究中,它被用于46位患者中的28位。nintedanib的总给药时间因服用的止泻药的数量而有显着差异:853±221天,超过三种药物;424±365天,无代理(p = 0.043);和460±142,一种药物(p = 0.0003)。结论当使用nintedanib后一年内出现腹泻时,在不影响肺功能的情况下减少剂量是可以接受的。此外,与单药治疗和无药治疗相比,采用多种止泻药治疗可能是维持使用Nintedanib疗法的一种实用选择。
更新日期:2020-03-20
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