Exploratory analysis of a phase III trial of pirfenidone identifies a subpopulation of patients with idiopathic pulmonary fibrosis as benefiting from treatment

Respiratory Research

Volumn 12, Issue , 2011, Pages

  Azuma, Arata ^a   Taguchi, Yoshio ^b   Ogura, Takashi ^c   Ebina, Masahito ^d   Taniguchi, Hiroyuki ^e   Kondoh, Yasuhiro ^e   Suga, Moritaka ^f   Takahashi, Hiroki ^g   Nakata, Koichiro ^h   Sato, Atsuhiko ⁱ   Kudoh, Shoji ^a   Nukiwa, Toshihiro ^d  

^a NIPPON MEDICAL SCHOOL   (Japan)

^b TENRI HOSPITAL   (Japan)

^c Kanagawa Prefectural Cardiovascular and Respiratory Center Hospital   (Japan)

^d TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^e TOSEI GENERAL HOSPITAL   (Japan)

^f SAISEIKAI KUMAMOTO HOSPITAL   (Japan)

^g SAPPORO MEDICAL UNIVERSITY HOSPITAL   (Japan)

^h Nakata Clinic   (Japan)

ⁱ Kyoto Preventive Medical Center   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

OXYGEN; PIRFENIDONE; PYRIDONE DERIVATIVE;

6 MINUTE STEADY STATE EXERCISE TEST; ADULT; AGED; ARTICLE; BLOOD OXYGEN TENSION; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DYSPNEA; EXERCISE TEST; EXPLORATORY RESEARCH; FEMALE; FIBROSING ALVEOLITIS; FLETCHER, HUGH JONES CLASSIFICATION SCALE; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OXYGEN SATURATION; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PULSE OXIMETRY; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; VITAL CAPACITY; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DRUG EFFECT; MIDDLE AGED; PATHOPHYSIOLOGY; PHYSIOLOGY; TREATMENT OUTCOME;

ADULT; AGED; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; MALE; MIDDLE AGED; PYRIDONES; TREATMENT OUTCOME; VITAL CAPACITY; YOUNG ADULT;

EID: 81255146512     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/1465-9921-12-143     Document Type: Article

References (25)

1. Bjoraker JA, Ryu JH, Edwin MK, Myers JL, Tazelaar HD, Schroeder DR, Offord KP. Prognostic significance of histopathologic subsets in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 1998, 157:199-203.
2. Schwartz DA, Helmers RA, Galvin JR, Van Fossen DS, Frees KL, Dayton CS, Burmeister LF, Hunninghake GW. Determinants of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 1994, 149:450-454.
3. Azuma A. Pirfenidone: antifibrotic agent for idiopathic pulmonary fibrosis. Expert Rev Resp Med 2010, 4:301-310.
4. Raghu G, Johnson WC, Lockhart D, Mageto Y. Treatment of idiopathic pulmonary fibrosis with a new antifibrotic agent, pirfenidone: results of a prospective, open-label Phase II study. Am J Respir Crit Care Med 1999, 159:1061-1069.
5. Gahl WA, Brantly M, Troendle J, Avila NA, Padua A, Montalvo C, Cardona H, Calis KA, Gochuico B. Effect of pirfenidone on the pulmonary fibrosis of Hermansky-Pudlak syndrome. Mol Genet Metab 2002, 76:234-242. 10.1016/S1096-7192(02)00044-6, 12126938.
6. Nagai S, Hamada K, Shigematsu M, Taniyama M, Yamauchi S, Izumi T. Open-label compassionate use one year-treatment with pirfenidone to patients with chronic pulmonary fibrosis. Intern Med 2002, 41:1118-1123. 10.2169/internalmedicine.41.1118, 12521199.
7. Azuma A, Nukiwa T, Tsuboi E, Suga M, Abe S, Nakata K, Taguchi Y, Nagai S, Itoh H, Ohi M, Sato A, Kudoh S, Raghu G. Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2005, 171:1040-1047. 10.1164/rccm.200404-571OC, 15665326.
8. Iyer SN, Gurujeyalakshmi G, Giri SN. Effects of pirfenidone on transforming growth factor-beta gene expression at the transcriptional level in bleomycin hamster model of lung fibrosis. J Pharmacol Exp Ther 1999, 291:367-373.
9. Gurujeyalakshmi G, Hollinger MA, Giri SN. Pirfenidone inhibits PDGF isoforms in bleomycin hamster model of lung fibrosis at the translational level. Am J Physiol 1999, 276:L311-L318.
10. Iyer SN, Gurujeyalakshmi G, Giri SN. Effects of pirfenidone on procollagen gene expression at the transcriptional level in bleomycin hamster model of lung fibrosis. J Pharmacol Exp Ther 1999, 289:211-218.
11. Misra HP, Rabideau C. Pirfenidone inhibits NADPH-dependent microsomal lipid peroxidation and scavenges hydroxyl radicals. Mol Cell Biochem 2000, 204:119-126. 10.1023/A:1007023532508, 10718632.
12. Oku H, Shimizu T, Kawabata T, Nagira M, Hikita I, Ueyama A, Matsushima S, Torii M, Arimura A. 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):400-408.
13. Taniguchi H, Ebina M, Kondoh Y, Ogura T, Azuma A, Suga M, Taguchi Y, Takahashi H, Nakata K, Sato A, Takeuchi M, Raghu G, Kudoh S, Nukiwa T, . Pirfenidone Clinical Study Group in Japan Pirfenidone in Idiopathic Pulmonary Fibrosis: A phase III clinical trial in Japan. Eur Respir J 2010, 35:821-829. 10.1183/09031936.00005209, 19996196, Pirfenidone Clinical Study Group in Japan.
14. Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE, Lancaster L, Sahn SA, Szwarcberg J, Valeyre D, du Bois RM, . for the CAPACITY Study Group Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet 2011, 377:1760-1769. 10.1016/S0140-6736(11)60405-4, 21571362, for the CAPACITY Study Group.
15. Ebina M, Kimura Y, Ohta H, Ohkouchi S, Hisata S, Hirota N, Tamada T, Nukiwa T, . Clinical Study Group of Pirfenidone in Japan Enhanced effects of pirfenidone on the early phase of idiopathic pulmonary fibrosis [abstract]. ERS Annual Congress 2009, P666. Clinical Study Group of Pirfenidone in Japan.
16. Ebina M, Kimura Y, Ohta H, Hisata S, Tamada T, Nukiwa T, . Clinical Study Group of Pirfenidone in Japan Pirfenidone, a novel anti-fibrotic agent, provides higher benefit for idiopathic pulmonary fibrosis (IPF) patients with better pulmonary function. Am J Respir Crit Care Med 2010, 181:A3988. Clinical Study Group of Pirfenidone in Japan.
17. American Thoracic Society Idiopathic pulmonary fibrosis: diagnosis and treatment: international consensus statement: American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med 2000, 161:646-664. American Thoracic Society.
18. Clinical diagnostic and treatment guidance for idiopathic interstitial pneumonias. Nankodo 2004, 63-65. Japanese Respiratory Society's Committee formulating diagnosis and treatment guideline for diffuse lung diseases. Tokyo, [in Japanese].
19. Fletcher CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc Royal Soc Med 1952, 45:577-584.
20. Restrictive Diseases. Pulmonary Pathophysiology. The Essentials 2008, Lippincott Williams & Wilkins, a Woltera Kluwer business, West JB, Seven.
21. King TE, Albera C, Bradford WZ, Costabel PU, Hormel P, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, du Bois RM, . the INSPIRE Study Group Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial. Lancet 2009, 374:222-228. 10.1016/S0140-6736(09)60551-1, 19570573, the INSPIRE Study Group.
22. Slides for the March 9, 2010 Meeting of the Pulmonary-Allergy Drugs Advisory Committee, InterMune Core Presentation, Pirfenidone. for the March 9, 2010 Meeting of the Pulmonary-Allergy Drugs Advisory Committee (PDF-980KB) , http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM206399.pdf
23. Collard HR. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J 2010, 35:728-729. 10.1183/09031936.00006610, 20356985.
24. Swigris J, Fairclough D. Pirfenidone in idiopathic pulmonary fibrosis. Eur Respir J 2010, 36:695-696. 10.1183/09031936.00071710, 20930209.
25. Nukiwa T, Ebina M, Takeuchi M. Pirfenidone in idiopathic pulmonary fibrosis: From the authors. Eur Respir J 2010, 36:696-698.