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Safety and pharmacokinetics of nintedanib and pirfenidone in idiopathic pulmonary fibrosis.
- Source :
-
The European respiratory journal [Eur Respir J] 2015 May; Vol. 45 (5), pp. 1382-92. Date of Electronic Publication: 2014 Dec 10. - Publication Year :
- 2015
-
Abstract
- A randomised, double-blind, phase II, dose escalation trial was conducted to assess the safety, tolerability and pharmacokinetics of the tyrosine kinase inhibitor nintedanib, alone and when added to ongoing pirfenidone therapy, in Japanese patients with idiopathic pulmonary fibrosis. 50 Japanese patients were randomised to receive nintedanib or placebo in one of three cohorts (nintedanib 50 mg twice daily or 100 mg twice daily for 14 days, or 150 mg twice daily for 28 days). Patients receiving pirfenidone at inclusion were stratified to every nintedanib dose group and placebo. Adverse events were reported in nine out of 17 patients receiving nintedanib alone and 10 out of 21 patients receiving nintedanib added to pirfenidone. All adverse events were mild or moderate in intensity. Gastrointestinal disorders were the most common adverse event. Maximum plasma concentration and area under the curve at steady state for nintedanib and its metabolites tended to be lower when nintedanib was added to pirfenidone. Nintedanib had no effect on the pharmacokinetics of pirfenidone. In conclusion, further study is needed to evaluate the safety and tolerability profile of nintedanib when added to pirfenidone in patients with idiopathic pulmonary fibrosis. There was a trend toward lower exposure of nintedanib when it was added to pirfenidone.<br /> (Copyright ©ERS 2015.)
- Subjects :
- Aged
Anti-Inflammatory Agents, Non-Steroidal administration & dosage
Anti-Inflammatory Agents, Non-Steroidal adverse effects
Anti-Inflammatory Agents, Non-Steroidal pharmacokinetics
Dose-Response Relationship, Drug
Double-Blind Method
Enzyme Inhibitors administration & dosage
Enzyme Inhibitors adverse effects
Enzyme Inhibitors pharmacokinetics
Female
Humans
Indoles administration & dosage
Indoles adverse effects
Japan
Male
Middle Aged
Patient Safety
Pyridones administration & dosage
Pyridones adverse effects
Treatment Outcome
Vital Capacity
Idiopathic Pulmonary Fibrosis drug therapy
Indoles pharmacokinetics
Pyridones pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 1399-3003
- Volume :
- 45
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- The European respiratory journal
- Publication Type :
- Academic Journal
- Accession number :
- 25504994
- Full Text :
- https://doi.org/10.1183/09031936.00198013