Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: A systematic review and meta-analysis

Therapeutic Advances in Respiratory Disease

Volumn 7, Issue 1, 2013, Pages 13-24

  Oba, Yuji ^a   Lone, Nazir A ^a  

^a University of Missouri   (United States)

Author keywords

chronic obstructive; meta analysis; outcome assessment (health care); phosphodiesterase 4 inhibitors; pulmonary disease

Indexed keywords

CORTICOSTEROID; PLACEBO; ROFLUMILAST; SALMETEROL; TIOTROPIUM BROMIDE;

APPETITE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL EFFECTIVENESS; DATA BASE; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FORCED EXPIRATORY VOLUME; HEADACHE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; INFECTION; INSOMNIA; LUNG FUNCTION; META ANALYSIS; NAUSEA; PNEUMONIA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY FAILURE; REVIEW; RISK FACTOR; SIDE EFFECT; SUICIDE; SYSTEMATIC REVIEW; THORAX PAIN; TREATMENT DURATION; TREMOR; WEIGHT REDUCTION;

AGED; AMINOPYRIDINES; BENZAMIDES; CYCLOPROPANES; DISEASE PROGRESSION; FEMALE; HUMANS; LUNG; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; ODDS RATIO; PHOSPHODIESTERASE 4 INHIBITORS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 84873661428     PISSN: 17534658     EISSN: 17534666     Source Type: Journal    
DOI: 10.1177/1753465812466167     Document Type: Review

References (30)

1. Aaron S. Vandemheen K. Fergusson D. Maltais F. Bourbeau J. Goldstein R. (2007) Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 146: 545–555.
2. Anonymous (2011) Roflumilast (Daliresp) for COPD. Med Lett Drugs Ther 53: 59–60.
3. Barnes P. (2008) Emerging pharmacotherapies for COPD. Chest 134: 1278–1286.
4. Bateman E. Rabe K. Calverley P. Goehring U. Brose M. Bredenbroker D. (2011) Roflumilast with long-acting beta2-agonists for COPD: influence of exacerbation history. Eur Respir J 38: 553–560.
5. Cahana A. Mauron A. (2006) The story of Vioxx-no pain and a lot of gain: ethical concerns regarding conduct of the pharmaceutical industry. J Anesth 20: 348–351.
6. Calverley P. Martinez F. Fabbri L. Goehring U. Rabe K. (2012) Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? the REACT study protocol. Int J Chron Obstruct Pulmon Dis 7: 375–382.
7. Calverley P. Rabe K. Goehring U. Kristiansen S. Fabbri L. Martinez F. (2009) Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet 374: 685–694.
8. Calverley P. Sanchez-Toril F. McIvor A. Teichmann P. Bredenbroeker D. Fabbri L. (2007) Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med 176: 154–161.
9. Cyr M. Beauchesne M. Lemiere C. Blais L. (2008) Effect of theophylline on the rate of moderate to severe exacerbations among patients with chronic obstructive pulmonary disease. Br J Clin Pharmacol 65: 40–50.
10. Fabbri L. Calverley P. Izquierdo-Alonso J. Bundschuh D. Brose M. Martinez F. (2009) Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet 374: 695–703.
11. FDA (Food and Drug Administration) (2010) Pulmonary-Allergy Drugs Advisory Committee (PADAC). Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM212109.pdf ( accessed 27 August 2012).
12. Forest Research Institute (2010) DAXAS® (roflumilast) in chronic obstructive pulmonary disease. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM207379.pdf ( accessed 27 August 2012).
13. Giembycz M. (2006) An update and appraisal of the cilomilast phase III clinical development programme for chronic obstructive pulmonary disease. Br J Clin Pharmacol 62: 138–152.
14. Grootendorst D. Gauw S. Verhoosel R. Sterk P. Hospers J. Bredenbroker D. (2007) Reduction in sputum neutrophil and eosinophil numbers by the PDE4 inhibitor roflumilast in patients with COPD. Thorax 62: 1081–1087.
15. Guyatt G. Townsend M. Pugsley S. Keller L. Short H. Taylor D. (1987) Bronchodilators in chronic air-flow limitation. Effects on airway function, exercise capacity, and quality of life. Am Rev Respir Dis 135: 1069–1074.
16. Halbert R. Natoli J. Gano A. Badamgarav E. Buist A. Mannino D. (2006) Global burden of COPD: systematic review and meta-analysis. Eur Respir J 28: 523–532.
17. Hertel N. Kotchie R. Samyshkin Y. Radford M. Humphreys S. Jameson K. (2012) Cost-effectiveness of available treatment options for patients suffering from severe COPD in the UK: a fully incremental analysis. Int J Chron Obstruct Pulmon Dis 7: 183–199.
18. Hilleman D. Dewan N. Malesker M. Friedman M. (2000) Pharmacoeconomic evaluation of COPD. Chest 118: 1278–1285.
19. Kelly Freeman M. (2012) Clinical considerations for roflumilast: a new treatment for COPD. Consult Pharm 27: 189–193.
20. Kochanek K. Xu J. Murphy S. Miniño A. Kung H. (2011) US Department of Health and Human Services, CDC, National Center for Health Statistics. National Vital Statistics Reports. Deaths: preliminary data for 2009. Available at http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_04.pdf ( accessed 27 August 2012).
21. Lee S. Hui D. Mahayiddin A. Roa C. Jr Kwa K. Goehring U. (2011) Roflumilast in Asian patients with COPD: a randomized placebo-controlled trial. Respirology 16: 1249–1257.
22. Moher D. Cook D. Eastwood S. Olkin I. Rennie D. Stroup D. (1999) Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of reporting of meta-analyses. Lancet 354: 1896–1900.
23. Moher D. Hopewell S. Schulz K. Montori V. Gotzsche P. Devereaux P. (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 63: e1–e37.
24. Murciano D. Auclair M. Pariente R. Aubier M. (1989) A randomized, controlled trial of theophylline in patients with severe chronic obstructive pulmonary disease. N Engl J Med 320: 1521–1525.
25. Puhan M. (2011) Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 8: ED000028.
26. Rabe K. Bateman E. O–Donnell D. Witte S. Bredenbroker D. Bethke T. (2005) Roflumilast ’ an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 366: 563–571.
27. Ram F. Jones P. Castro A. De Brito J. Atallah A. Lacasse Y. (2002) Oral theophylline for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 4: CD003902.
28. Rennard S. Calverley P. Goehring U. Bredenbroker D. Martinez F. (2011) Reduction of exacerbations by the PDE4 inhibitor roflumilast-the importance of defining different subsets of patients with COPD. Respir Res 12: 18.
29. Rutten-van Molken M. van Nooten F. Lindemann M. Caeser M. Calverley P. (2007) A 1-year prospective cost-effectiveness analysis of roflumilast for the treatment of patients with severe chronic obstructive pulmonary disease. Pharmacoeconomics 25: 695–711.
30. Welte T. Miravitlles M. Hernandez P. Eriksson G. Peterson S. Polanowski T. (2009) Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 180: 741–750.