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      Efficacy and tolerance of tacrolimus and pimecrolimus for atopic dermatitis: a meta-analysis

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          Abstract

          Tacrolimus ointment and pimecrolimus cream have proved to be suitable for the treatment of atopic dermatitis. We conducted a meta-analysis of the efficacy, adverse events/withdrawal of tacrolimus versus pimecrolimus in the treatment of atopic dermatitis. According to our meta-analysis, 0.1% tacrolimus was more effective than 1% pimecrolimus in the treatment of adult patients and moderate to very severe pediatric patients, and more 0.1% mild pediatric patients treatal with pimecrolimus withdrew from the trials because of a lack of efficacy or the occurrence of adverse events, compared with mild pediatric patients treated with 0.03% tacrolimus. The combined analyses of tacrolimus with pimecrolimus showed that tacrolimus was more effective than pimecrolimus (week 3: RR=0.67, 95%CI=0.56-0.80; week 6/end of study: RR=0.65, 95%CI=0.57-0.75), and fewer tacrolimus-treated patients withdrew because of a lack of efficacy (RR=0.32, 95CI%=0.19-0.53) or the occurrence of adverse events (RR=0.43, 95%CI=0.24-0.75), compared with pimecrolimus-treated patients. In conclusion, tacrolimus has higher efficacy and better tolerance than pimecrolimus in the treatment of atopic dermatitis.

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          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.

          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). One thousand and sixty-five patients were randomized to treatment in 3 multicenter, randomized, investigator-blinded, 6-week studies. 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). 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.
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            A randomized investigator-blinded study comparing pimecrolimus cream 1% with tacrolimus ointment 0.03% in the treatment of pediatric patients with moderate atopic dermatitis.

            To evaluate pimecrolimus cream 1% and tacrolimus ointment 0.03% in pediatric patients with moderate atopic dermatitis (AD). 141 patients (aged 2-17 years) were randomized to treatment with pimecrolimus cream 1% (n=71) or tacrolimus ointment 0.03% (n=70) twice daily for 6 weeks. At day 4, local, application-site reactions were less common and of shorter duration with pimecrolimus than with tacrolimus. Incidence of erythema/irritation was 8% (6/71) with pimecrolimus compared with 19% (13/70) with tacrolimus (P=.039). Fewer patients receiving pimecrolimus (0%, 0/6) experienced erythema/irritation lasting >30 minutes, compared with those receiving tacrolimus (85%, 11/13; P 30 minutes were fewer with pimecrolimus (0%, 0/14) than with tacrolimus (67%, 8/12; P <.001). More patients receiving pimecrolimus rated ease of application as 'excellent' or 'very good', compared with tacrolimus (76% vs 59%, respectively; P <.020). Efficacy was similar in both groups at day 43. Both treatments were generally well tolerated with no unexpected adverse events. Pimecrolimus cream 1% had better formulation attributes and local tolerability than tacrolimus ointment 0.03% while providing similar efficacy and overall safety in pediatric patients with moderate AD.
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              Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis.

              To compare the efficacy and safety of tacrolimus ointment 0.1% and pimecrolimus cream 1% in adult patients with moderate to very severe atopic dermatitis (AD). A total of 281 patients (141 treated with tacrolimus and 140 treated with pimecrolimus) were randomized to a multicenter, investigator-blinded, 6-week study. Tacrolimus-treated patients had significantly greater improvements in the Eczema Area Severity Index score compared with pimecrolimus-treated patients (mean percent reduction from baseline to study end: 57% vs 39%, respectively; p=0.0002). Treatment success was also significantly greater among the tacrolimus-treated patients compared with pimecrolimus-treated patients (40% vs 22% at study end; p=0.001), as was the improvement in percentage of total body surface area affected (a reduction of 49% vs 34% at study end; p=0.01). Both treatment groups had similar improvements in patient assessment of itch. There were no significant differences in the incidences of adverse events, including application-site burning and application-site pruritus, the two most commonly reported adverse events. Significantly more pimecrolimus-treated patients than tacrolimus-treated patients withdrew from the study due to lack of efficacy (10 vs 1, p=0.005). Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.
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                Author and article information

                Journal
                J Biomed Res
                J Biomed Res
                JBR
                Journal of Biomedical Research
                Editorial Department of Journal of Biomedical Research
                1674-8301
                November 2011
                : 25
                : 6
                : 385-391
                Affiliations
                [a ]Department of Dermatology;
                [b ]Department of Oncology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China.
                Author notes
                [△]

                These authors contributed equally to this study.

                *Corresponding author: Dan Luo, M.D., Department of Dermatology, the First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, Jiangsu 210029, China. Tel:+86-13655187928, E-mail: daniluo2005@ 123456yahoo.com.cn .

                The authors reported no conflict of interest.

                Article
                jbr-25-06-385
                10.1016/S1674-8301(11)60051-1
                3596717
                23554715
                e52b2346-d70f-4978-bd8a-75cb47f8c6b2
                © 2011 by the Journal of Biomedical Research. All rights reserved.

                This work is licensed under a Creative Commons Attribution 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by/3.0/

                History
                : 2 May 2011
                : 25 June 2011
                : 21 July 2011
                Categories
                Research Paper

                tacrolimus,pimecrolimus,atopic dermatitis,meta-analysis
                tacrolimus, pimecrolimus, atopic dermatitis, meta-analysis

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