Pirfenidone in Idiopathic Pulmonary Fibrosis: Expert Panel Discussion on the Management of Drug-Related Adverse Events

Advances in Therapy - Tập 31 Số 4 - Trang 375-391 - 2014
Ulrich Costabel1, Elisabeth Bendstrup2, Vincent Cottin3, Pieter Dewint4, Jim Egan5, J. Ferguson6, Richard Groves7, Per M. Hellström8, Michael Kreuter9,10, Toby M. Maher11, María Molina-Molina12, Klas Nordlind13, Alexandre Sarafidis14, Carlo Vancheri15
1Universität Duisburg-Essen = University of Duisburg-Essen [Essen]
2Department of Respiratory Medicine and Allergology
3Rétrovirus et Pathologie Comparée
4Erasmus University, Rotterdam
5Mater Misericordiae University Hospital
6Ninewells Hospital
7King's College London
8 Uppsala University
9Respiratory Critical Care Medicine Heidelberg
10Universität Heidelberg [Heidelberg] = Heidelberg University
11Royal Brompton Hospital
12Centro de Investigación Biomédica en Red Enfermedades Respiratorias
13University Hospital
14Centre Hospitalier Interrégional Edith Cavell
15Università degli studi di Catania = University of Catania

Tóm tắt

Từ khóa


Tài liệu tham khảo

Gribbin J, Hubbard RB, Le Jeune I, Smith CJ, West J, Tata LJ. Incidence and mortality of idiopathic pulmonary fibrosis and sarcoidosis in the UK. Thorax. 2006;61:980–5.

Hodgson U, Laitinen T, Tukiainen P. Nationwide prevalence of sporadic and familial idiopathic pulmonary fibrosis: evidence of founder effect among multiplex families in Finland. Thorax. 2002;57:338–42.

Karakatsani A, Papakosta D, Rapti A, Antoniou KM, Dimadi M, Markopoulou A, et al. Epidemiology of interstitial lung diseases in Greece. Respir Med. 2009;103:1122–9.

Navaratnam V, Fleming KM, West J, Smith CJ, Jenkins RG, Fogarty A, et al. The rising incidence of idiopathic pulmonary fibrosis in the UK. Thorax. 2011;66:462–7.

Thomeer MJ, Costabe U, Rizzato G, Poletti V, Demedts M. Comparison of registries of interstitial lung diseases in three European countries. Eur Respir J Suppl. 2001;32:114s–8s.

von Plessen C, Grinde O, Gulsvik A. Incidence and prevalence of cryptogenic fibrosing alveolitis in a Norwegian community. Respir Med. 2003;97:428–35.

Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev [Research Support, Non-U.S. Gov’t Review]. 2012;21:355–61.

Collard HR, Moore BB, Flaherty KR, et al. Acute exacerbations of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2007;176:636–43.

Kim DS, Collard HR, King TE Jr. Classification and natural history of the idiopathic interstitial pneumonias. Proc Am Thorac Soc. 2006;3:285–92.

Meltzer EB, Noble PW. Idiopathic pulmonary fibrosis. Orphanet J Rare Dis. 2008;3:8.

Raghu G, Collard HR, Egan JJ, et al. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183:788–824.

Ley B, Collard HR, King TE Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;183:431–40.

Antoniou KM, Margaritopoulos GA, Siafakas NM. Pharmacological treatment of idiopathic pulmonary fibrosis: from the past to the future. Eur Respir Rev. 2013;22:281–91.

Taniguchi H, Ebina M, Kondoh Y, et al. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J. 2010;35:821–9.

Noble PW, Albera C, Bradford WZ, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011;377:1760–9.

Grattendick KJ, Nakashima JM, Feng L, Giri SN, Margolin SB. Effects of three anti-TNF-alpha drugs: etanercept, infliximab and pirfenidone on release of TNF-alpha in medium and TNF-alpha associated with the cell in vitro. Int Immunopharmacol. 2008;8:679–87.

Liu H, Drew P, Gaugler AC, Cheng Y, Visner GA. Pirfenidone inhibits lung allograft fibrosis through l-arginine-arginase pathway. Am J Transplant. 2005;5:1256–63.

Oku H, Nakazato H, Horikawa T, Tsuruta Y, Suzuki R. Pirfenidone suppresses tumor necrosis factor-alpha, enhances interleukin-10 and protects mice from endotoxic shock. Eur J Pharmacol. 2002;446:167–76.

Nakayama S, Mukae H, Sakamoto N, et al. Pirfenidone inhibits the expression of HSP47 in TGF-beta1-stimulated human lung fibroblasts. Life Sci. 2008;82:210–7.

Oku H, Shimizu T, Kawabata T, et al. Antifibrotic action of pirfenidone and prednisolone: different effects on pulmonary cytokines and growth factors in bleomycin-induced murine pulmonary fibrosis. Eur J Pharmacol. 2008;590:400–8.

Schaefer CJ, Ruhrmund DW, Pan L, Seiwert SD, Kossen K. Antifibrotic activities of pirfenidone in animal models. Eur Respir Rev. 2011;20:85–97.

Rubino CM, Bhavnani SM, Ambrose PG, Forrest A, Loutit JS. Effect of food and antacids on the pharmacokinetics of pirfenidone in older healthy adults. Pulm Pharmacol Ther. 2009;22:279–85.

European Medicine Agency. Esbriet® (pirfenidone) Summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002154/WC500103049.pdf (last accessed Feb 2014).

Azuma A, Nukiwa T, Tsuboi E, et al. Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2005;171:1040–7.

du Bois RM, Nathan SD, Richeldi L, Schwarz MI, Noble PW. Idiopathic pulmonary fibrosis: lung function is a clinically meaningful endpoint for phase III trials. Am J Respir Crit Care Med. 2012;186:712–5.

Cottin V. Changing the idiopathic pulmonary fibrosis treatment approach and improving patient outcomes. Eur Respir Rev. 2012;21:161–7.

Valeyre D, Albera C, Bradford W, et al. The long-term safety of pirfenidone (PFD) in patients with idiopathic pulmonary fibrosis (IPF). Eur Respir J. 2013;42(Suppl 57)(563s):P3159.

Jiang C, Huang H, Liu J, Wang Y, Lu Z, Xu Z. Adverse events of pirfenidone for the treatment of pulmonary fibrosis: a meta-analysis of randomized controlled trials. PLoS ONE. 2012;7:e47024.

Itoh T, Koyabu K, Morimoto A, et al. Ameliorative effects of mosapride or Rikkunshi-to on the suppression of gastrointestinal motility by pirfenidone in rats. Jpn Pharmacol Ther. 2012;40:405–11.

Seto Y, Inoue R, Kato M, Yamada S, Onoue S. Photosafety assessments on pirfenidone: photochemical, photobiological, and pharmacokinetic characterization. J Photochem Photobiol B. 2013;120:44–51.

Pharmaceuticals and Medical Devices Agency Japan. Pirfenidone report. http://www.pmda.go.jp/english/service/pdf/drugs/pirespa_oct2008_e.pdf (last accessed Feb 2014).

Chaudhuri N, Duck A, Frank R, Holme J, Leonard C. Real world experiences: pirfenidone is well tolerated in patients with idiopathic pulmonary fibrosis. Respir Med. 2014;108:224–6.

Clinical trials.gov. Safety and tolerability of pirfenidone in patients with systemic sclerosis-related interstitial lung disease (SSc-ILD) (LOTUSS). http://clinicaltrials.gov/ct2/show/NCT01933334?term=lotuss&rank=1 (last accessed Feb 2014).

Cho ME, Kopp JB. Pirfenidone: an anti-fibrotic therapy for progressive kidney disease. Expert Opin Investig Drugs. 2010;19:275–83.

Ito M. Post-marketing surveillance of pirfenidone for idiopathic pulmonary fibrosis in Japan: Interim analysis of 973 patients. Eur Respir J. 2012;40:563s.

Lee JS, Ryu JH, Elicker BM, et al. Gastroesophageal reflux therapy is associated with longer survival in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011;184:1390–4.

Electronic Medicines Compendium. Patient information leaflet: pirfenidone. http://www.medicines.org.uk/emc/medicine/26916/PIL/Esbriet+267+mg+hard+capsules/ (last accessed Feb 2014).

European Medicine Agency. Pirfenidone CHMP assessment report. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002154/WC500103073.pdf (last accessed Feb 2014).