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Published Online, 30 May 2006, www.theannals.com, DOI 10.1345/aph.1E651.
 The Annals of Pharmacotherapy: Vol. 40, No. 6, pp. 1096-1104. DOI 10.1345/aph.1E651
© 2006 Harvey Whitney Books Company.
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NEW DRUG DEVELOPMENTS

The Potential Role of Roflumilast: The New Phosphodiesterase-4 Inhibitor

Sarah B Karish, PharmD

Assistant Professor, Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences, Boston, MA

James M Gagnon, PharmD

Assistant Professor, Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences

Reprints: Dr. Karish, Massachusetts College of Pharmacy and Health Sciences, 179 Longwood Ave., Boston, MA 02115-5804, fax 617/732-2244, skarish{at}bos.mcphs.edu

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of roflumilast in the treatment of asthma and chronic obstructive pulmonary disease (COPD).

DATA SOURCES: Studies, review articles, and meeting abstracts evaluating roflumilast were obtained from MEDLINE (1966-May 16, 2006), EMBASE (1980-May 16, 2006), and International Pharmaceutical Abstracts (1970-May 16, 2006) databases. Key terms used in all of the database searches were roflumilast, phosphodiesterase-4 inhibitor, asthma, chronic obstructive pulmonary disease, and COPD. Company Web sites were reviewed, and bibliographies of selected articles were evaluated for pertinent articles.

STUDY SELECTION AND DATA EXTRACTION: In vitro, in vivo, and animal studies were selected, as were published human studies on the efficacy and safety of roflumilast. Due to limited published data on its safety, efficacy, pharmacokinetics, and drug interactions, meeting abstracts were also selected. Data retrieved from abstracts only is indicated in the references.

DATA SYNTHESIS: Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE 4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It has been studied as an oral tablet in doses of 250 or 500 µg/day. Animal data and clinical trials have demonstrated roflumilast's efficacy and safety as an antiinflammatory and antimodulatory agent for use in asthma and COPD, with no documented drug interactions and a favorable adverse effect profile.

CONCLUSIONS: Roflumilast may be an additional option in the treatment of asthma and COPD due to its ease of administration and a seemingly favorable adverse event profile. However, more research is needed to solidify roflumilast's place in therapy.

Key Words: asthma, COPD, phosphodiesterase-4 inhibitor, roflumilast

Published Online, May 30, 2006. www.theannals.com, DOI 10.1345/aph.1E651

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-06-010-H01




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