Tepede Abisola, Yogaratnam Dinesh
1 Novartis Institutes of Biomedical Research, Cambridge, MA, USA.
2 Massachusetts College of Pharmacy and Health Sciences University, Worcester, MA, USA.
J Pharm Pract. 2019 Apr;32(2):199-206. doi: 10.1177/0897190017735242. Epub 2017 Oct 10.
To review the pharmacology, safety, and efficacy of nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).
A literature search was conducted via PubMed using the MeSH term "idiopathic pulmonary fibrosis" combined with the key word "nintedanib." Additional online searches using Google Scholar, Micromedex, and PubMed were performed to obtain prescribing and cost information.
One phase II and 2 replicate phase III clinical trials that examined the safety and efficacy of nintedanib for IPF were identified. In patients with IPF, nintedanib was more effective than placebo in slowing the annual rate of decline in forced vital capacity (FVC). Improvements in mortality, quality of life, and risk of acute exacerbations have not been consistently demonstrated in clinical trials. Diarrhea was the most common adverse effect associated with nintedanib use. Outside of these clinical trials, there are limited data evaluating nintedanib for the treatment of IPF.
Nintedanib is a safe and effective treatment option for patients with IPF. Nintedanib slows IPF disease progression by reducing the rate of decline in FVC. Reductions in mortality and acute exacerbations may be present in certain subgroups of patients, but these outcomes require further research. Future studies on nintedanib are needed to explore its use in more advanced stages of IPF, its long-term safety and efficacy, its value in combination with pirfenidone or other therapies for IPF, and its cost-effectiveness in clinical practice.
综述尼达尼布治疗特发性肺纤维化（IPF）的药理学、安全性及疗效。
通过PubMed以医学主题词“特发性肺纤维化”结合关键词“尼达尼布”进行文献检索。还使用谷歌学术、Micromedex和PubMed进行了额外的在线搜索，以获取处方和成本信息。
确定了一项评估尼达尼布治疗IPF安全性和疗效的II期临床试验以及2项重复的III期临床试验。在IPF患者中，尼达尼布在减缓用力肺活量（FVC）年下降率方面比安慰剂更有效。临床试验中尚未一致证明其在死亡率、生活质量和急性加重风险方面有改善。腹泻是与使用尼达尼布相关的最常见不良反应。在这些临床试验之外，评估尼达尼布治疗IPF的数据有限。
尼达尼布是IPF患者一种安全有效的治疗选择。尼达尼布通过降低FVC下降率减缓IPF疾病进展。在某些患者亚组中可能存在死亡率和急性加重的降低，但这些结果需要进一步研究。需要对尼达尼布进行未来研究，以探索其在IPF更晚期阶段的应用、长期安全性和疗效、与吡非尼酮或其他IPF治疗联合使用的价值以及其在临床实践中的成本效益。
