PMID- 15858471
OWN - NLM
STAT- MEDLINE
DCOM- 20060421
LR  - 20141120
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 52
IP  - 5
DP  - 2005 May
TI  - Tacrolimus ointment is more effective than pimecrolimus cream with a similar 
      safety profile in the treatment of atopic dermatitis: results from 3 randomized, 
      comparative studies.
PG  - 810-22
AB  - OBJECTIVE: To compare the efficacy and safety of tacrolimus ointment and 
      pimecrolimus cream in adult and pediatric patients with mild to very severe 
      atopic dermatitis (AD). METHODS: One thousand and sixty-five patients were 
      randomized to treatment in 3 multicenter, randomized, investigator-blinded, 
      6-week studies. RESULTS: Based on the Eczema Area Severity Index (EASI), 
      tacrolimus ointment was more effective than pimecrolimus cream at the end of the 
      study in adults (54.1% vs. 34.9%, respectively; P < .0001), in children with 
      moderate/severe disease (67.2% vs. 56.4%, respectively; P = .04), in the combined 
      analysis (52.8% vs. 39.1%, respectively; P < .0001), and at week 1 in children 
      with mild disease (39.2% vs. 31.2%, respectively; P = .04). Tacrolimus was also 
      more effective than pimecrolimus based on the Investigator Global AD Assessment 
      (IGADA), improvement in percentage of total body surface area affected, and 
      improvement in itch scores (P < or = .05), with a faster onset of action. There 
      was no significant difference in the incidence of adverse events (AEs), including 
      application site reactions in the 2 studies involving 650 children. Adults 
      treated with tacrolimus experienced a greater number of local application site 
      reactions on day 1; both groups reported a similar incidence of application site 
      reactions thereafter. More pimecrolimus-treated patients than tacrolimus-treated 
      patients withdrew from the studies because of a lack of efficacy (P < or = .03) 
      or adverse events (P = .002; pediatric mild). CONCLUSION: Tacrolimus ointment is 
      more effective and has a faster onset of action than pimecrolimus cream in adults 
      and children with AD; their safety profiles are similar.
FAU - Paller, Amy S
AU  - Paller AS
AD  - Northwestern University Medical School/Children's Memorial Hospital, Chicago, 
      Illinois 60611-2923, USA. apaller@northwestern.edu
FAU - Lebwohl, Mark
AU  - Lebwohl M
FAU - Fleischer, Alan B Jr
AU  - Fleischer AB Jr
FAU - Antaya, Richard
AU  - Antaya R
FAU - Langley, Richard G
AU  - Langley RG
FAU - Kirsner, Robert S
AU  - Kirsner RS
FAU - Blum, Robin R
AU  - Blum RR
FAU - Rico, M Joyce
AU  - Rico MJ
FAU - Jaracz, Eileen
AU  - Jaracz E
FAU - Crowe, Andrew
AU  - Crowe A
FAU - Linowski, Gregory J
AU  - Linowski GJ
CN  - US/Canada Tacrolimus Ointment Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Ointments)
RN  - 7KYV510875 (pimecrolimus)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Dermatitis, Atopic/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Ointments
MH  - Patient Satisfaction
MH  - Tacrolimus/administration & dosage/adverse effects/*analogs & 
      derivatives/*therapeutic use
EDAT- 2005/04/29 09:00
MHDA- 2006/04/25 09:00
CRDT- 2005/04/29 09:00
PHST- 2005/04/29 09:00 [pubmed]
PHST- 2006/04/25 09:00 [medline]
PHST- 2005/04/29 09:00 [entrez]
AID - S019096220404229X [pii]
AID - 10.1016/j.jaad.2004.12.038 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2005 May;52(5):810-22. doi: 10.1016/j.jaad.2004.12.038.