RETRACTED: Pimecrolimus Cream 1% in the Management of Atopic Dermatitis in Pediatric Patients: A Meta-Analysis (Retracted article. See vol. 9, e108566, 2014)

Objective: To evaluate the efficacy and safety of pimecrolimus cream 1% in the treatment of AD in the pediatric population. Methods: PubMed, EMBASE, Web of Science and Cochrane library databases were searched till July 2013. The randomized and nonrandomized blinded studies of pimecrolimus cream 1% applied twice daily with Jaded score >= 3 in pediatric patients with AD were included. The efficacy outcomes included investigator global assessment ( IGA), eczema area and severity index ( EASI) scores, pruritus and care giver's assessments and flares free period. Adverse events were reviewed to assess the safety. Results: Out of 81 studies, 7 were selected that enrolled 2,170 pediatric patients. The pooled analysis reported that pimecrolimus was no better to vehicle reducing eczema at day- 8, day- 26 and six weeks ( OR 4.95, 95% CI 2.79-8.80), ( OR 9.69, 95% CI 4.12- 22.83) and ( OR 3.83. 95% CI 1.94- 7.56), respectively in children. Similarly, pimecrolimus did not show beneficial effects when analyzed for mild or absent pruritus at day 4 ( OR 8.29, 95% CI 3.88- 17.72 favoring vehicle), day 43 ( OR 1.81 95% CI 1.13-2.89 favoring vehicle) and 1 week ( OR 2.29, 95% CI 1.45 to 3.60 favoring vehicle) as compared with vehicle. One study comparing pimecrolimus with tacrolimus found no significant difference in achieving mild or absent pruritus ( OR 0.94, 95% CI 0.44-1.99). More patients showed an improvement in overall disease in vehicle group at day 8 ( OR 3.30, 95% CI 2.03-5.35), day 29 ( OR 14.14, 95% CI 6.87- 29.13) and day 43 ( OR 4.11, 95% CI 2.59-6.52) as compared with pimecrolimus 1% group, as assessed by caregivers. No significant difference was seen between the total AEs in both groups ( pimecrolimus vs vehicle/ tacrolimus) ( OR 1.19, 95% CI 0.85, 1.65) Conclusion: The results of the present meta- analysis showed that pimecrolimus cream 1% was not significantly better to vehicle for AD in pediatrics population.