Evidence Table 10

Quality assessment of active-controlled trials of pimecrolimus

Author, Year
Country
Randomization adequate?Allocation concealment adequate?Groups similar at baseline?Eligibility criteria specified?Outcome assessors masked?Care provider masked?Patient masked?Reporting of attrition, crossovers, adherence, and contaminationTotal withdrawals: differential/highIntention-to-treat (ITT) analysisPost-randomization exclusionsQuality RatingFunding
Luger, 2004Method not describedMethod not describedYesYesUnclear, reported as double-blindUnclear, reported as double-blindYes, each patient received 3 tubes of cream with labels for appropriate areas.Yes
NR
NR
NR
NR
NR-Total withdrawal rate not reported for both arms, 58.8% withdrew from pimecrolimus arm. Of the 30% with severe disease, 36.3% pimecrolimus vs. 8.2% topical steroid withdrew due to unsatisfactory therapeutic effect.
Yes, for safety.

No, for efficacy: used observed data.
NoFairNovartis
Luger, 2001Method not describedMethod not describedYesYesUnclear, reported as double-blindUnclear, reported as double-blindUnclear, reported as double-blindYes
NR
NR
NR
29
Yes, there was high differential seen with those randomized to vehicle compared with the other arms
Yes; unclear how missing data were handledNoFairNR

From: Evidence Tables

Cover of Drug Class Review: Topical Calcineurin Inhibitors
Drug Class Review: Topical Calcineurin Inhibitors: Final Report [Internet].
Lee NJ, McDonagh M, Chan B, et al.
Portland (OR): Oregon Health & Science University; 2008 Oct.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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