Prednicarbate versus Fluocortin for Inflammatory Dermatoses

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Abstract
The purpose of this study was to compare, from a societal perspective, the cost effectiveness of topical prednicarbate 0.25% and fluocortin 0.75% in the treatment of inflammatory dermatoses, such as dermatitis and eczema, in Spain. Effectiveness and tolerability were determined by means of a meta-analysis of 17 randomised double-blind controlled clinical trials, using a MEDLINE search and a second-level reference search. The data were obtained on the basis of a per-protocol assessment system, and the Mantel-Haenszel method (as modified by Peto) was used to make the statistical analysis. In terms of economic assessment, a model was developed in which the expected total cost was determined by the cost of the medicine (adjusted to the recommended dosage) plus the costs derived from the ineffectiveness and/or adverse effects associated with the different treatments. A sensitivity analysis was carried out on the basis of changes in: (i) clinical effectiveness; (ii) price of prednicarbate; (iii) incidence of adverse reactions; (iv) costs associated with ineffectiveness and/or adverse effects; and (v) the regimen under which prednicarbate was administered. The meta-analysis showed that there was a statistically significant difference between the 2 alternatives (p = 0.001). The value of a combined odds ratio [and 95% confidence interval (95% CI)] for the combined studies of prednicarbate was 1.54 (95% CI 1.10 to 2.15), compared with 0.73 (95% CI 0.60 to 0.89) for fluocortin relative to moderate or moderate-to-high potency corticosteroids. Effectiveness was 84.9% for prednicarbate and 69.7% for fluocortin, while frequency of adverse effects was 3.5% for prednicarbate and 4.9% for fluocortin. The total expected cost per patient treated was found to be 4600 Spanish pesetas (Pta) [$US37.10; 1996 values] for prednicarbate and Pta5778 ($US46.60; 1996 values) for fluocortin. The total expected cost per patient successfully treated was Pta5608 ($US45.20) for prednicarbate and Pta8680 ($US70) for fluocortin. Prednicarbate has been shown to have a favourable cost-effectiveness ratio, when compared with fluocortin, for the treatment of dermatitis and eczema in Spain. Additional pharmacoeconomic studies on topical corticosteroids are required, including the use of new variables, long term analysis and/or the measurements of the effect of the drug on patients’ quality of life.