The divergent opinions of regulatory authorities on roflumilast are puzzling but we need new drugs for treating chronic obstructive pulmonary disease

Therapeutic Advances in Respiratory Disease

Volumn 4, Issue 4, 2010, Pages 195-198

  Cazzola, Mario ^a  

^a UNIVERSITY OF ROME TOR VERGATA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; BUDESONIDE PLUS FORMOTEROL; CORTICOSTEROID; CYCLIC AMP; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; HISTONE DEACETYLASE 2; PHOSPHATIDYLINOSITOL 3 KINASE; PHOSPHODIESTERASE IV INHIBITOR; PLACEBO; PROTEIN KINASE B; ROFLUMILAST; THEOPHYLLINE; TIOTROPIUM BROMIDE;

ADRENAL SUPPRESSION; ASTHMA; BONE DENSITY; CANCER INCIDENCE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; DIARRHEA; DISEASE EXACERBATION; DRUG ACTIVITY; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDITORIAL; FOOD AND DRUG ADMINISTRATION; FORCED EXPIRATORY VOLUME; FRACTURE; GENE EXPRESSION; GLAUCOMA; HUMAN; MEDICAL PRACTICE; NAUSEA; NEOPLASM; OXIDATIVE STRESS; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; RISK FACTOR; SIDE EFFECT; SIGNAL TRANSDUCTION; SKIN BRUISING; SUICIDE; SUICIDE ATTEMPT; UNSPECIFIED SIDE EFFECT; WEIGHT REDUCTION;

AMINOPYRIDINES; BENZAMIDES; CYCLOPROPANES; DRUG APPROVAL; DRUG DESIGN; EUROPE; HUMANS; PHOSPHODIESTERASE 4 INHIBITORS; PHOSPHODIESTERASE INHIBITORS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77955575182     PISSN: 17534658     EISSN: None     Source Type: Journal    
DOI: 10.1177/1753465810377636     Document Type: Editorial

References (23)

1. Anzueto, A., Leimer, I. and Kesten, S. (2009) Impact of frequency of COPD exacerbations on pulmonary function, health status and clinical outcomes. Int J Chron Obstruct Pulmon Dis 4: 245-251.
2. Barnes, P.J. ( 2006) Reduced histone deacetylase in COPD: Clinical implications. Chest 129: 151-155.
3. Bateman, E.D., Hurd, S.S., Barnes, P.J., Bousquet, J., Drazen, J.M., FitzGerald, M. et al. (2008) Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J 31: 143-178.
4. Boswell-Smith, V., Cazzola, M. and Page, C.P. ( 2006) Are phosphodiesterase 4 inhibitors just more theophylline? J Allergy Clin Immunol 11: 1237-1243.
5. Calverley, P.M., Rabe, K.F., Goehring, U.M., Kristiansen, S., Fabbri, L.M. and Martinez, F.J. (2009) Roflumilast in symptomatic chronic obstructive pulmonary disease: Two randomised clinical trials. Lancet 374: 685-694.
6. Calverley, P.M., Sanchez-Toril, F., McIvor, A., Teichmann, P., Bredenbroeker, D. and Fabbri, L.M. ( 2007) Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med 176: 154-161.
7. Cazzola, M., Bettoncelli, G., Sessa, E. and Cricelli, C. (2009) Primary care of the patient with chronic obstructive pulmonary disease in Italy. Respir Med 103: 582-588.
8. Cazzola, M., Picciolo, S. and Matera, M.G. (2010) Roflumilast in chronic obstructive pulmonary disease: Evidence from large trials. Expert Opin Pharmacother 11: 441-449.
9. Celli, B.R. ( 2008) What is the best pharmacological treatment to prevent exacerbation of chronic obstructive pulmonary disease? Pol Arch Med Wewn 118: 172-174.
10. Cosio, B.G., Tsaprouni, L., Ito, K., Jazrawi, E., Adcock, I.M. and Barnes, P.J. ( 2004) Theophylline restores histone deacetylase activity and steroid responses in COPD macrophages. J Exp Med 200: 689-695.
11. Gizycki, M.J., Hattotuwa, K.L., Barnes, N. and Jeffery, P.K. ( 2002) Effects of fluticasone propionate on inflammatory cells in COPD: An ultrastructural examination of endobronchial biopsy tissue. Thorax 57: 799-803.
12. Grootendorst, D.C., Gauw, S.A., Verhoosel, R.M., Sterk, P.J., Hospers, J.J., Bredenbröker, D. et al. (2007) Reduction in sputum neutrophil and eosinophil numbers by the PDE4 inhibitor roflumilast in patients with COPD. Thorax 62: 1081-1087.
13. Ito, K., Ito, M., Elliott, W.M., Cosio, B., Caramori, G., Kon, O.M. et al. (2005) Decreased histone deacetylase activity in chronic obstructive pulmonary disease. N Engl J Med 352: 1967-1976.
14. Rabe, K.F., Bateman, E.D., O–Donnell, D., Witte, S., Bredenbröker, D. and Bethke, T.D. ( 2005) Roflumilast - an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: A randomised controlled trial. Lancet 366: 563-571.
15. Rabe, K.F., Hurd, S., Anzueto, A., Barnes, P.J., Buist, S.A., Calverley, P. et al. (2007) Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med 176: 532-555.
16. Rodrigo, G.J., Castro-Rodriguez, J.A. and Plaza, V. (2009) Safety and efficacy of combined long-acting beta-agonists and inhaled corticosteroids vs long-acting beta-agonists monotherapy for stable COPD: A systematic review. Chest 136: 1029-1038.
17. Roy, K., Smith, J., Kolsum, U., Borrill, Z., Vestbo, J. and Singh, D. ( 2009) COPD phenotype description using principal components analysis. Respir Res 10: 41.
18. Saha, S. and Brightling, C.E. ( 2006) Eosinophilic airway inflammation in COPD. Int J Chron Obstruct Pulmon Dis 1: 39-47.
19. Sousa, L.P., Carmo, A.F., Rezende, B.M., Lopes, F., Silva, D.M., Alessandri, A.L. et al. (2009) Cyclic AMP enhances resolution of allergic pleurisy by promoting inflammatory cell apoptosis via inhibition of PI3K/Akt and NF-kB. Biochem Pharmacol 78: 396-405.
20. Tattersfield, A.E., Harrison, T.W., Hubbard, R.B. and Mortimer, K. ( 2004) Safety of inhaled corticosteroids. Proc Am Thorac Soc 1: 171-175.
21. To, Y., Ito, K., Kizawa, Y., Failla, M., Ito, M., Kusama, T. et al. (2010) Targeting phosphoinositide-3-kinase-δ with theophylline reverses corticosteroid insensitivity COPD. Am J Respir Crit Care Med, doi:10.1164/rccm.200906-0937OC.
22. Walker, E.P. ( 2010) Panel votes against new PDE4 inhibitor for COPD. Available at http://www.medpagetoday.com/Pulmonology/SmokingCOPD/19448.
23. Wedzicha, J.A. and Seemungal, T.A. ( 2007) COPD exacerbations: Defining their cause and prevention. Lancet 370: 786-796.