Gastrointestinal pirfenidone adverse events in idiopathic pulmonary fibrosis depending on diet: the MADIET clinical trial

Maria Molina-Molina^{1

2}, Jessica Germaine Shull³, Vanesa Vicens-Zygmunt^{3

2}, Pilar Rivera-Ortega⁴, Katerina Antoniou⁵, Francesco Bonella⁶, Elisabetta Renzoni⁷, Anne-Marie Russell⁸, Toby M Maher^{9

10}, Ada Vancheri¹¹, Anna Bachs³, Victoria Avilés¹², Josep Palma³, Guadalupe Bermudo^{3

2}, Guillermo Suarez-Cuartin^{3

2}, Cristian Tebé¹³, Raul Rigo-Bonnin¹⁴, Ana Montes-Worboys^{3

2}, Marlies Wijsenbeek¹⁵, Carlo Vancheri¹¹

Affiliations

¹ Interstitial Lung Disease Unit, Respiratory Department, University Hospital of Bellvitge, Research Lab 4126, IDIBELL, UB, Barcelona, Spain mariamolinamolina@hotmail.com.
² Spanish Research Network in Respiratory Diseases (CIBERES), Barcelona, Spain.
³ Interstitial Lung Disease Unit, Respiratory Department, University Hospital of Bellvitge, Research Lab 4126, IDIBELL, UB, Barcelona, Spain.
⁴ NIHR Manchester Clinical Research Facility, Interstitial Lung Disease Unit, Respiratory Medicine Department, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
⁵ Laboratory of Cellular and Molecular Pneumonology, Dept of Respiratory Medicine, School of Medicine, University of Crete, Heraklion, Greece.
⁶ Center for Interstitial and Rare Lung Diseases, Ruhrlandklinik, University Hospital, University of Duisburg Essen, Essen, Germany.
⁷ NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.
⁸ Exeter Respiratory Institute, University of Exeter and Royal Devon University Hospitals NHS Foundation Trust, Exeter, UK.
⁹ Keck Medicine of University of Southern California, Los Angeles, CA, USA.
¹⁰ National Heart and Lung Institute, Imperial College, London, UK.
¹¹ Dept of Clinical and Experimental Medicine, Regional Referral Centre for Rare Lung Diseases, University Hospital "Policlinico G. Rodolico - San Marco", University of Catania, Catania, Italy.
¹² Unit of Nutritional Support, University Hospital of Vall d'Hebron, Barcelona, Spain.
¹³ Dept of Biostatistics, IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.
¹⁴ Dept of Clinical Laboratory, Bellvitge University Hospital, IDIBELL, Barcelona, Spain.
¹⁵ Dept of Respiratory Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.

PMID: 37857429
PMCID: PMC10586233
DOI: 10.1183/13993003.00262-2023

Clinical Trial

Gastrointestinal pirfenidone adverse events in idiopathic pulmonary fibrosis depending on diet: the MADIET clinical trial

Maria Molina-Molina et al. Eur Respir J. 2023.

. 2023 Oct 19;62(4):2300262.

doi: 10.1183/13993003.00262-2023. Print 2023 Oct.

Authors

Affiliations

¹ Interstitial Lung Disease Unit, Respiratory Department, University Hospital of Bellvitge, Research Lab 4126, IDIBELL, UB, Barcelona, Spain mariamolinamolina@hotmail.com.
² Spanish Research Network in Respiratory Diseases (CIBERES), Barcelona, Spain.
³ Interstitial Lung Disease Unit, Respiratory Department, University Hospital of Bellvitge, Research Lab 4126, IDIBELL, UB, Barcelona, Spain.
⁴ NIHR Manchester Clinical Research Facility, Interstitial Lung Disease Unit, Respiratory Medicine Department, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
⁵ Laboratory of Cellular and Molecular Pneumonology, Dept of Respiratory Medicine, School of Medicine, University of Crete, Heraklion, Greece.
⁶ Center for Interstitial and Rare Lung Diseases, Ruhrlandklinik, University Hospital, University of Duisburg Essen, Essen, Germany.
⁷ NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.
⁸ Exeter Respiratory Institute, University of Exeter and Royal Devon University Hospitals NHS Foundation Trust, Exeter, UK.
⁹ Keck Medicine of University of Southern California, Los Angeles, CA, USA.
¹⁰ National Heart and Lung Institute, Imperial College, London, UK.
¹¹ Dept of Clinical and Experimental Medicine, Regional Referral Centre for Rare Lung Diseases, University Hospital "Policlinico G. Rodolico - San Marco", University of Catania, Catania, Italy.
¹² Unit of Nutritional Support, University Hospital of Vall d'Hebron, Barcelona, Spain.
¹³ Dept of Biostatistics, IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.
¹⁴ Dept of Clinical Laboratory, Bellvitge University Hospital, IDIBELL, Barcelona, Spain.
¹⁵ Dept of Respiratory Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.

PMID: 37857429
PMCID: PMC10586233
DOI: 10.1183/13993003.00262-2023

Abstract

Individuals with IPF who follow a MUFA diet report a lower incidence of pirfenidone gastrointestinal adverse events than those that follow a SFA diet, which could explain the different prevalence in GI pirfenidone AEs reported by countries in IPF cohorts https://bit.ly/3LuzAUJ

Trial registration: ClinicalTrials.gov NCT03539289.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: M. Molina-Molina declares grants and fees received for research projects or scientific advice from Esteve-Teijin, Roche, Boehringer Ingelheim and Chiesi. V. Vicens-Zygmunt received fees for scientific advice from Boehringer Ingelheim. P. Rivera-Ortega declares speaker and consultation fees from Boehringer Ingelheim and Hoffmann-La Roche, and fees received for research projects from Boehringer Ingelheim, Hoffmann-La Roche, CSL Behring, FibroGen, Vicore Pharma AB, Gilead Sciences and Galecto; all research fees were paid to her institution. F. Bonella declares speaker and consultation fees from Boehringer Ingelheim, Hoffman La Roche and Fibrogene, outside the submitted work. E. Renzoni reports grants, lecture fees and advisory board fees from Boehringer Ingelheim, lecture fees from Roche and Chiesi, research grants from Raynaud's and Scleroderma, and support for attending meetings from Boehringer Ingelheim, outside the submitted work; all grants and fees were paid to her institution. A-M. Russell declares speaker and consultation fees from Boehringer Ingelheim and Hoffman-La Roche. T.M. Maher reports consultancy fees from AstraZeneca, Bayer, Blade Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, Galecto, GlaxoSmithKline, IQVIA, Pliant, Respivant Sciences, Roche/Genentech, Theravance Biopharma and Veracyte, and fees for presentations from Boehringer Ingelheim and Roche/Genentech. G. Suarez-Cuartin has received grants from Grifols, travel grants from Chiesi, Menarini and Boehringer Ingelheim, a speaker fee from Insmed, and advisory board fees from Insmed Inc. and Zambon. M. Wijsenbeek has received grants from Boehringer Ingelheim, The Netherlands Organisation for Health Research and Development, The Dutch Lung Foundation, Sarcoidose.nl and The Dutch Pulmonary Society, consulting fees from Boehringer Ingelheim, Galapagos, Bristol Myers Squibb, Galecto, Respivant, NeRRe Therapeutics, Horizon Therapeutics, PureTech health, Kinevant Sciences, Molecure and CLS Behring, speaker fees from Boehringer Ingelheim, Hoffman-La Roche, Novartis and CLS Behring, support for attending meetings from Boehringer Ingelheim, Galapagos and Hoffman-La Roche, and has participated in advisory boards of different patient associations (unpaid); all grants and fees were paid to her institution. C. Vancheri served on advisory committees of InterMune, Roche, AstraZeneca, Sanofi, Insmed, Zambon and Boehringer Ingelheim, and received lecture fees and nongovernmental research support from InterMune, Roche, Boehringer Ingelheim, Novartis, Chiesi, Menarini, AstraZeneca, GSK, Sanofi and Insmed. The rest of the authors have no relevant relationships to disclose.

References

1. Lancaster L, Albera C, Bradford WZ, et al. . Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res 2016; 3: e000105. - PMC - PubMed
1. Raghu G, Remy-Jardin M, Myers JL, et al. . Diagnosis of idiopathic pulmonary fibrosis. An official ATS/ERS/JRS/ALAT clinical practice guideline. Am J Respir Crit Care Med 2018; 198: e44–e68. doi:10.1164/rccm.201807-1255ST - DOI - PubMed
1. Cottin V, Koschel D, Günther A, et al. . Long-term safety of pirfenidone: results of the prospective, observational PASSPORT study. ERJ Open Res 2018; 4: 00084-2018. doi:10.1183/23120541.00084-2018 - DOI - PMC - PubMed
1. Glass DS, Grossfeld D, Renna HA, et al. . Idiopathic pulmonary fibrosis: current and future treatment. Clin Respir J 2022; 16: 84–96. doi:10.1111/crj.13466 - DOI - PMC - PubMed
1. Noble PW, Albera C, Bradford WZ, et al. . Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials. Eur Respir J 2016; 47: 243–253. doi:10.1183/13993003.00026-2015 - DOI - PMC - PubMed

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
Medical
- ClinicalTrials.gov

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Gastrointestinal pirfenidone adverse events in idiopathic pulmonary fibrosis depending on diet: the MADIET clinical trial

Affiliations

Gastrointestinal pirfenidone adverse events in idiopathic pulmonary fibrosis depending on diet: the MADIET clinical trial

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical