The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: Extended analysis of the pirfenidone trial

Respiratory Research

Volumn 12, Issue , 2011, Pages

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

^a TOSEI GENERAL HOSPITAL   (Japan)

^b TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c NIPPON MEDICAL SCHOOL   (Japan)

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

^e TENRI HOSPITAL   (Japan)

^f SAISEIKAI KUMAMOTO HOSPITAL   (Japan)

^g SAPPORO MEDICAL UNIVERSITY HOSPITAL   (Japan)

^h Nakata Clinic   (Japan)

ⁱ Kyoto Preventive Medical Center   (Japan)

^j JICHI MEDICAL UNIVERSITY   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PIRFENIDONE; PLACEBO; PYRIDONE DERIVATIVE; RESPIRATORY TRACT AGENT;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; FIBROSING ALVEOLITIS; GENERAL CONDITION DETERIORATION; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PREDICTIVE VALUE; PROGNOSIS; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; TREATMENT OUTCOME; VITAL CAPACITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE COURSE; DISEASE FREE SURVIVAL; DRUG EFFECT; JAPAN; KAPLAN MEIER METHOD; LUNG; MIDDLE AGED; PATHOPHYSIOLOGY; RISK ASSESSMENT; RISK FACTOR; TIME;

AGED; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; JAPAN; KAPLAN-MEIER ESTIMATE; LUNG; MIDDLE AGED; PYRIDONES; RESPIRATORY SYSTEM AGENTS; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; VITAL CAPACITY;

EID: 79960556065     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/1465-9921-12-93     Document Type: Article

References (27)

1. King TE, Albera C, Bradford WZ, Costabel U, Hormel P, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, du Bois RM, . INSPIRE Study Group Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE.: A multicentre, randomized, placebo-controlled trial. Lancet 2009, 374:222-228. 10.1016/S0140-6736(09)60551-1, 19570573, INSPIRE Study Group.
2. du Bois RM. Strategies for treating idiopathic pulmonary fibrosis. Nat Rev Drug Discov 2010, 9:129-140. 10.1038/nrd2958, 20094055.
3. 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.
4. 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.
5. 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.
6. 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. for the members of the Research Group for Diffuse Lung Diseases in Japan 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, for the members of the Research Group for Diffuse Lung Diseases in Japan.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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. 10.1016/j.ejphar.2008.06.046, 18598692.
12. 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. Eur Respir J 2010, 35:821-829. 10.1183/09031936.00005209, 19996196, Pirfenidone Clinical Study Group in Japan.
13. Latsi PI, du Bois RM, Nicholson AG, Colby TV, Bisirtzoglou D, Nikolakopoulou A, Veeraraghavan S, Hansel DM, Wells AU. Fibrotic idiopathic interstitial pneumonia: The prognostic value of longitudinal functional trends. Am J Respir Crit Care Med 2003, 168:531-537. 10.1164/rccm.200210-1245OC, 12791580.
14. Collard HR, King TE, Bartelson BB, Vourlekis JS, Schwarz MI, Brown KK. Changes in clinical and physiologic variables predict survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2003, 168:538-542. 10.1164/rccm.200211-1311OC, 12773325.
15. Flaherty KR, Mumford JA, Murray S, Kazerooni EA, Gross BH, Colby TV, Travis WD, Flint A, Toews GB, Lynch III JP, Martinez FJ. Prognostic implications of physiologic and radiographic changes in idiopathic interstitial pneumonia. Am J Respir Crit Care Med 2003, 168:543-548. 10.1164/rccm.200209-1112OC, 12773329.
16. 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.
17. Zappala CJ, Latsi PI, Nicholson AG, Colby TV, Cramer D, Renzoni EA, Hansell DM, du Bois RM, Wells AU. Marginal decline in forced vital capacity is associated with a poor outcome in idiopathic pulmonary fibrosis. Eur Respir J 2010, 35:830-835. 10.1183/09031936.00155108, 19840957.
18. Clinical diagnostic and treatment guidance for idiopathic interstitial pneumonias. Japanese Respiratory Society's Committee formulating diagnosis and treatment guideline for diffuse lung diseases 2004, 63-65. Tokyo: Nankodo, [in Japanese].
19. Nukiwa T, Ebina M, Takeuchi M. Pirfenidone in idiopathic pulmonary fibrosis: From the authors. Eur Respir J 2010, 36:696-698.
20. Fletcher CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc Royal Soc Med 1952, 45:577-584.
21. King TE, Safrin S, Starko KM, Brown KK, Noble PW, Raghu G, Schwartz DA. Analyses of efficacy end points in a controlled trial of interferon-gamma1b for idiopathic pulmonary fibrosis. Chest 2005, 127:171-177. 10.1378/chest.127.1.171, 15653980.
22. Demedts M, Behr J, Buhl R, Costabel U, Dekhuijzen R, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Capron F, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Corvasce G, Lankhorst I, Sardina M, Montanari M. High-Dose Acetylcysteine in Idiopathic Pulmonary Fibrosis. N Engl J Med 2005, 353:2229-42. 10.1056/NEJMoa042976, 16306520.
23. Raghu G, Brown KK, Bradford WZ, Starko K, Noble PW, Schwartz DA, King TE. A Placebo-Controlled Trial of Interferon Gamma-1b in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med 2004, 350:125-33. 10.1056/NEJMoa030511, 14711911.
24. Raghu G, Brown KK, Costabel U, Cottin V, du Bois RM, Lasky JA, Thomeer M, Utz JP, Khandker RK, McDermott L, Fatenejad S. Treatment of idiopathic pulmonary fibrosis with etanercept: An exploratory, placebocontrolled trial. Am J Respir Crit Care Med 2008, 178:948-955. 10.1164/rccm.200709-1446OC, 18669816.
25. King TE, Behr J, Brown KK, du Bois RM, Lancaster L, de Andrade JA, Stähler G, Leconte I, Roux S, Raghu G. BUILD-1: a randomized placebo-controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2008, 177:75-81.
26. Behr J, Demedts M, Buhl R, Costabel U, Dekhuijzen RP, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Lankhorst I, Sardina M, Boissard G, . IFIGENIA study group Lung function in idiopathic pulmonary fibrosis - extended analyses of the IFIGENIA trial. Respir Res 2009, 10:101. 10.1186/1465-9921-10-101, 2774307, 19860915, IFIGENIA study group.
27. Selman M, Pardo A, Richeldi L, Cerri S. Emerging drugs for idiopathic pulmonary fibrosis. Expert Opin Emerg Drug 2011, 16:341-362.