Clinical considerations for roflumilast: A new treatment for COPD

Consultant Pharmacist

Volumn 27, Issue 3, 2012, Pages 189-193

  Freeman, Maisha Kelly ^a  

^a SAMFORD UNIVERSITY   (United States)

Author keywords

Chronic obstructive pulmonary disease; Phosphodiesterase inhibitor; Roflumilast

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CYCLIC AMP; CYTOCHROME P450 3A4; PLACEBO; ROFLUMILAST;

CHRONIC OBSTRUCTIVE LUNG DISEASE; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG METABOLISM; FORCED EXPIRATORY VOLUME; HUMAN; MAXIMUM PLASMA CONCENTRATION; MENTAL DISEASE; NAUSEA; REVIEW; SIDE EFFECT; WEIGHT REDUCTION;

ADMINISTRATION, ORAL; AMINOPYRIDINES; BENZAMIDES; BRONCHITIS, CHRONIC; CYCLIC AMP; CYCLOPROPANES; CYTOCHROME P-450 CYP3A; DRUG INTERACTIONS; HUMANS; PHOSPHODIESTERASE 4 INHIBITORS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SEVERITY OF ILLNESS INDEX;

EID: 84859478617     PISSN: 08885109     EISSN: None     Source Type: Journal    
DOI: 10.4140/TCP.n.2012.189     Document Type: Review

References (28)

1. Chronic obstructive pulmonary disease (COPD). Available at http://www.who.int/respiratory/copd/en/. Accessed June 10, 2011.
2. COPD predicted to be third leading cause of death in 2030. Available at http://www.who.int/respiratory/copd/World-Health-Statistics-2008/en/index.html. Accessed June 10, 2011.
3. Global Initiative for Chronic Obstructive Lung Disease. GOLD Report Updated 2010. Available at http://www.goldcopd.com/Guidelineitem.asp?l1= 2&l2=1&intId=989. Accessed June 13, 2011.
4. Hatzelmann A, Morcillo EJ, Lungarella G et al. The preclinical pharmacology of roflumilast - a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease. Pulm Pharmacol Ther 2010;23:235-56.
5. Williams DM, Bourdet SV. Chronic obstructive pulmonary disease. In DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey M, eds. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York, NY: McGraw-Hill; 2011:482.
6. Roflumilast package insert. Available at http://www.frx.com/pi/Daliresp- pi.pdf. Accessed April 19, 2011.
7. Dastidar SG, Ray A, Shirumall R et al. Pharmacology of a novel, orally active PDE4 inhibitor. Pharmacol 2009;83:275-86.
8. Lexi-Comp Online. Available at http://www.crlonline.com.ezproxy.samford. edu/crlsql/servlet/crlonline. Accessed April 19, 2011.
9. Rabe KF, Bateman ED, O'Donnell D et al. Roflumilast - an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomized controlled trial. Lancet 2005;366:563-71. (Pubitemid 41140331)
10. Grootendorst DC, Gauw SA, Verhoosel RM et al. Reduction in sputum neutrophil and eosinophil numbers by the PDE4 inhibitor roflumilast in patients with COPD. Thorax 2007;62:1081-7. (Pubitemid 350206202)
11. Molken M, van Nooten FE, Lindemann M et al. A 1-year prospective cost-effectiveness analysis of roflumilast for the treatment of patients with severe chronic obstructive pulmonary disease. Pharmacoeconomics 2007;25:695-711. (Pubitemid 47124171)
12. Calverley P, Sanchez-Toril F, McIvor A et al. Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2007;176:154-61. (Pubitemid 47057851)
13. Calverley P, Rabe KF, Goehering U et al. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomized clinical trials Lancet 2009;374:685-94.
14. Fabbri LM, Calverley PM, Izquierdo-Alonso J et al. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with long acting bronchodilators: two randomized clinical trials. Lancet 2009;374:695-703.
15. Rennard SI, Calverley P, Goehring UM et al. Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD. Respir Res 2011;12:18.
16. Mills EJ, Druyts E, Ghement I et al. Pharmacotherapies for chronic obstructive pulmonary disease: a multiple treatment comparison meta-analysis. Clin Epidemiol 2011;3:107-29.
17. Antoniu SA. New therapeutic options in the management of COPD - focus on roflumilast. Intern J COPD 2011;6:147-55.
18. Rabe KF. Update on roflumilast, a phosphodiesterase 4 inhibitor for the treatment of chronic obstructive pulmonary disease. Br J Pharmacol 2011;163:53-67.
19. Sanford M. Roflumilast: in chronic obstructive pulmonary disease. Drugs 2010;70:1615-27.
20. Clinical Pharmacology. Available at: http://clinicalpharmacology-ip.com. ezproxy.samford.edu/Forms/drugoptions aspx?cpnum=3518&n=Roflumilast. Accessed April 19, 2011.
21. Micromedex. Available at http://www.thomsonhc.com.ezproxy.samford.edu/ micromedex2/librarian/ND-T/evidencexpert/ND-PR/evidencexpert/CS/B1ABBF/ ND-AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/D0F809/ND-PG/evidencexpert/ ND-B/evidencexpert/ND-P/evidencexpert/PFActionId/evidencexpert. DisplayDrugpointDocument?docId=929815&contentSetId=100&title= Roflumilast&servicesTitle=Roflumilast&topicId=interactionsSection& subtopicId=null. Accessed April 19, 2011.
22. de Mey C, Nassr N, Lahu G. No relevant cardiac, pharmacokinetic or safety interactions between roflumilast and inhaled formoterol in healthy subjects: an open-label, randomised, actively controlled study. BMC Clin Pharmacol 2011;11:7.
23. McCracken N, Lahu G, Bethke TD. Lack of pharmacokinetic and pharmacodynamic interactions of roflumilast with (R, S)-warfarin in healthy adult subjects. Int J Clin Pharmacol Ther 2011;49:388-96.
24. Böhmer GM, Nassr N, Wenger M et al. The targeted oral, once-daily phosphodiesterase 4 inhibitor roflumilast and the leukotriene receptor antagonist montelukast do not exhibit significant pharmacokinetic interactions. J Clin Pharmacol 2009;49:389-97.
25. Böhmer GM, Gleiter CH, Mörike K et al. No dose adjustment on coadministration of the PDE4 inhibitor roflumilast with a weak CYP3A, CYP1A2, and CYP2C19 inhibitor: an investigation using cimetidine. J Clin Pharmacol 2011;51:594-602.
26. Nassr N, Huennemeyer A, Herzog R et al. Effects of rifampicin on the pharmacokinetics of roflumilast and roflumilast N-oxide in healthy subjects. Br J Clin Pharmacol 2009;68:580-7.
27. Rabe KF. Roflumilast for the treatment of chronic obstructive pulmonary disease. Exp Rev Respir Med. 2010;13:543-55.
28. European Medicines Agency. Daxas product information. Available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Product-Information/ human/001179/WC500095209.pdf. Accessed August 12, 2011.