Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Global Pharmacovigilance Data

被引:26
作者
Lasky, Joseph A. [1 ]
Criner, Gerard J. [2 ]
Lazarus, Howard M. [3 ]
Kohlbrenner, Veronika [3 ]
Bender, Shaun [3 ]
Richeldi, Luca [4 ]
机构
[1] Tulane Univ, Sch Med, 1430 Tulane Ave, New Orleans, LA 70112 USA
[2] Temple Univ, Lewis Katz Sch Med, Dept Thorac Med & Surg, Philadelphia, PA 19122 USA
[3] Boehringer Ingelheim Pharmaceut Inc, 90 E Ridge POB 368, Ridgefield, CT 06877 USA
[4] Univ Cattolica Sacro Cuore, Fdn Policlin A Gemelli IRCCS, Rome, Italy
关键词
Interstitial lung diseases; Monitoring; Drug; Postmarketing drug surveillance; Tyrosine kinase inhibitor; TRIPLE ANGIOKINASE INHIBITOR; EFFICACY;
D O I
10.1007/s12325-020-01452-5
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Introduction: The safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) have been characterized using data from clinical trials. Methods: We further characterized the safety and tolerability of nintedanib in patients with IPF in clinical practice using the global pharmacovigilance database. The database included spontaneously reported adverse events and data collected via solicited reporting in patients treated with nintedanib from 15 October 2014 to 15 October 2018. Adverse events were coded using the Medical Dictionary for Regulatory Activities. Cumulative exposure to nintedanib was estimated on the basis of sales data. Results: Cumulative exposure to nintedanib was estimated as 60,107 patient-years. Diarrhea was the most frequent event (301.6 events per 1000 patient-years). Most (97.0%) diarrhea events were non-serious. The median (25th, 75th percentile) time to onset of the first diarrhea event was 60 (11, 182) days. Elevated liver enzyme or bilirubin levels were reported at a rate of 31.5 events per 1000 patient-years. Bleeding was reported at a rate of 36.8 events per 1000 patient-years; 81.0% of events were non-serious. Major cardiovascular adverse events were reported at a rate of 13.4 events per 1000 patient-years and myocardial infarction at a rate of 4.3 events per 1000 patient-years. Gastrointestinal perforation was reported at a rate of 1.0 event per 1000 patient-years. Conclusions: On the basis of pharmacovigilance data collected over 4 years, the safety profile of nintedanib in patients with IPF was consistent with that observed in clinical trials and described in the product label, with no new safety concerns observed. [GRAPHICS] .
引用
收藏
页码:4209 / 4219
页数:11
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