Document Detail

Pharmacokinetics of topical calcineurin inhibitors in adult atopic dermatitis: a randomized, investigator-blind comparison.
MedLine Citation:
PMID:  16198779     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: We sought to compare pharmacokinetics of pimecrolimus cream 1% and tacrolimus ointment 0.1% in adults with extensive, moderate to severe atopic dermatitis. Secondary end points included efficacy and safety. METHODS: Patients received twice-daily treatment for 13 days. Blood concentrations of pimecrolimus and tacrolimus were measured at days 1, 5, and 13. Treatment success was defined as an Investigators' Global Assessment score of 0 (clear) or 1 (almost clear). RESULTS: Tacrolimus was detectable in 36% of blood samples and pimecrolimus was detectable in 12%. In patients with measurable blood drug concentrations, systemic exposure to tacrolimus (mean area under the curve(0-10h) < 9.7 ng.h/mL; n = 7) was higher than to pimecrolimus (mean area under the curve(0-10h) < 2.5 ng.h/mL; n = 2). Whole-body treatment success (day 13) was achieved in 1 of 18 (5.6%) and 2 of 19 (10.5%) patients treated with pimecrolimus and tacrolimus, respectively, and face/neck treatment success in 5 of 18 (27.8%) and 5 of 19 (26.3%) patients, respectively. Patients included in the study were adult patients with severe atopic dermatitis. The results and conclusions drawn from this study population may not be applicable for the majority of patients with atopic dermatitis who have mild to moderate disease. CONCLUSION: Pimecrolimus appears to be associated with lower systemic drug exposure than tacrolimus.
Zoe Draelos; Anjuli Nayak; David Pariser; Jerome L Shupack; Katie Chon; Beatrice Abrams; Carle F Paul
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American Academy of Dermatology     Volume:  53     ISSN:  1097-6787     ISO Abbreviation:  J. Am. Acad. Dermatol.     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-10-03     Completed Date:  2006-05-10     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  7907132     Medline TA:  J Am Acad Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  602-9     Citation Subset:  IM    
Dermatology Consulting Services, High Point, North Carolina, USA.
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MeSH Terms
Area Under Curve
Calcineurin / antagonists & inhibitors*
Dermatitis, Atopic / drug therapy*
Dermatologic Agents / administration & dosage,  blood,  pharmacokinetics*
Immunosuppressive Agents / administration & dosage,  blood,  pharmacokinetics*
Middle Aged
Single-Blind Method
Tacrolimus / administration & dosage,  analogs & derivatives*,  blood,  pharmacokinetics*
Reg. No./Substance:
0/Dermatologic Agents; 0/Immunosuppressive Agents; 0/pimecrolimus; 109581-93-3/Tacrolimus; EC

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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