A Cochrane review [Abstract] 1 included 31 studies with a total of 8 019 subjects. In short-term (≤ 6 weeks) trials, pimecrolimus cream was significantly more effective and well-tolerated than vehicle (cream base, but not containing pimecrolimus). In long-term trials (≥6 months), pimecrolimus was significantly better than vehicle in preventing flares (9 trials, 3 091 participants, RR 1.47, 95% CI 1.32 to 1.64) and in improving quality of life. Pimecrolimus was significantly less effective than two topical corticosteroids, i.e. 0.1% triamcinolone acetonide for investigators' global assessment (1 trial, 658 participants, RR 0.75, 95% CI 0.67 to 0.83) and 0.1% betamethasone valerate for participants' global assessment (1 trial, 87 participants, RR 0.61, 95% CI 0.45 to 0.81) at three weeks. Pimecrolimus was also associated with significantly more overall withdrawals and skin burning. None of the trials reported on key adverse effects such as thinning of skin. There was no statistically significant difference between 1.0% pimecrolimus and 0.03% tacrolimus in achieving clear or almost clear of eczema following one, three or six weeks of treatment (1 study, 567 children). Pimecrolimus 1% was significantly less effective than 0.1% tacrolimus for investigators' global assessment at six weeks (RR 0.58, 95% CI 0.46 to 0.74) and led to more withdrawals due to lack of efficacy (RR 2.37, 95% CI 1.10 to 5.08) based on two trials involving 639 participants, but there was no significant difference in proportions of participants experiencing any adverse events. There were no cancer-related events reported in any of the 31 clinical trials.
Comment: The quality of evidence is downgraded by study quality (more than 20% loss to follow up).
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