No relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone.


Journal

The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460

Informations de publication

Date de publication:
01 2019
Historique:
received: 01 03 2018
accepted: 28 10 2018
pubmed: 18 11 2018
medline: 2 10 2020
entrez: 17 11 2018
Statut: epublish

Résumé

Nintedanib and pirfenidone are approved treatments for idiopathic pulmonary fibrosis (IPF). This open-label, two-group trial investigated the pharmacokinetic drug-drug interaction between these two drugs in patients with IPF.Subjects not treated with antifibrotics at screening (group 1, n=20) received a single nintedanib dose (150 mg) followed by pirfenidone (titrated to 801 mg thrice daily) for 3 weeks, with a further single nintedanib dose (150 mg) on the last day (day 23). Subjects treated with pirfenidone at screening (group 2, n=17) continued to receive pirfenidone alone (801 mg thrice daily) for 7 days, then co-administered with nintedanib (150 mg twice daily) for a further 7 days, before single doses of both treatments on day 16.In group 1, adjusted geometric mean (gMean) ratios (with/without pirfenidone) were 88.6% and 80.6% for nintedanib area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C

Identifiants

pubmed: 30442716
pii: 13993003.01060-2018
doi: 10.1183/13993003.01060-2018
pii:
doi:

Substances chimiques

Indoles 0
Pyridones 0
pirfenidone D7NLD2JX7U
nintedanib G6HRD2P839

Types de publication

Clinical Trial, Phase IV Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright ©ERS 2019.

Déclaration de conflit d'intérêts

Conflict of interest: L. Richeldi reports grants and personal fees (member of an advisory board) from InterMune, personal fees for consultancy from Sanofi-Aventis, ImmuneWorks, Celgene, Nitto and Bristol Myers Squibb, personal fees as member of an advisory board from Roche, Fibrogen and Promedior, personal fees for speaking from Shionogi, personal fees as a member of a steering committee from Boehringer Ingelheim, personal fees for editorial activity from DynaMed, outside the submitted work. Conflict of interest: S. Fletcher has nothing to disclose. Conflict of interest: H. Adamali has nothing to disclose. Conflict of interest: N. Chaudhuri reports grants (for a project) from Boehringer Ingelheim, personal fees (for speakers fees) from Boehringer Ingelheim, other funding for educational sponsorship from Roche and Boehringer Ingelheim, and personal fees (for advisory boards) from Roche, outside the submitted work. Conflict of interest: S. Wiebe is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG. Conflict of interest: S. Wind is an employee of Boehringer Ingelheim Pharma GmbH & Co KG. Conflict of interest: K. Hohl has nothing to disclose. Conflict of interest: A. Baker is an employee of Boehringer Ingelheim. Conflict of interest: R. Schlenker-Herceg has nothing to disclose. Conflict of interest: S. Stowasser is an employee of Boehringer Ingelheim International GmbH. Conflict of interest: T.M. Maher has, via his institution, received industry-academic funding from GlaxoSmithKline R&D and UCB and has received consultancy or speakers fees from Apellis, AstraZeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Cipla, GlaxoSmithKline R&D, ProMetic, Roche, Sanumed and UCB.

Auteurs

Luca Richeldi (L)

Università Cattolica del Sacro Cuore, Fondazione Policlinico A. Gemelli, Rome, Italy.
Dept of Respiratory Medicine, University Hospital Southampton and Southampton NIHR Respiratory Biomedical Research Unit, University Hospital Southampton, Southampton, UK.

Sophie Fletcher (S)

Dept of Respiratory Medicine, University Hospital Southampton and Southampton NIHR Respiratory Biomedical Research Unit, University Hospital Southampton, Southampton, UK.
Translational Research Collaboration - Inflammatory Respiratory Disease Centre, Manchester, UK.

Huzaifa Adamali (H)

Bristol Interstitial Lung Disease Service, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.

Nazia Chaudhuri (N)

Translational Research Collaboration - Inflammatory Respiratory Disease Centre, Manchester, UK.
North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UK.

Sabrina Wiebe (S)

Boehringer Ingelheim Pharma, Biberach, Germany.

Sven Wind (S)

Boehringer Ingelheim Pharma, Biberach, Germany.

Kathrin Hohl (K)

Boehringer Ingelheim Pharma, Biberach, Germany.

Andrew Baker (A)

Boehringer Ingelheim, Bracknell, UK.

Rozsa Schlenker-Herceg (R)

Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.

Susanne Stowasser (S)

Boehringer Ingelheim International, Ingelheim am Rhein, Germany.

Toby M Maher (TM)

Translational Research Collaboration - Inflammatory Respiratory Disease Centre, Manchester, UK.
National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and Fibrosis Research group, National Heart and Lung Institute, Imperial College, London, UK.

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Classifications MeSH