Clinical and Pharmacoeconomic Analysis of the Fluconazole Use for the Prophylaxis of Invasive Candidiasis in Very-Low-Birth Weight Infants

Abstract

Very-low-birth weight preterm infants (<1500 g) are at high risk for invasive candidiasis. The prospective randomized controlled clinical trial comparing efficacy of 2 doses of fluconazole (3 and 6 mg/kg) in the prophylaxis of invasive candidiasis in infants (n=104) was performed. Historical control group included 249 infants. The descriptive and pharmacoeconomic analyses (cost of illness analysis; cost-minimization analysis; cost-effectiveness analysis) were used. Results of this study showed that invasive candidiasis developed more frequently in the control group, compared to both fluconazole groups. However, differences between two doses of fluconazole were not significant. Prophylactic use of fluconazole was associated with significantly decreased attributable mortality and was safe. Pharmacoeconomic analysis demonstrated that highest direct costs in the treatment of invasive candidiasis comprises for bed-days (81%), and the lowest one – for the cost of fluconazole (4%). Prophylactic use of fluconazole at dose of 3 mg/kg appeared to be more reasonable in terms of pharmacoeconomics, than the use of 6 mg/kg dose or management of preterm verylow-birth weight infants without antifungal prophylaxis. Therefore we recommend 3 mg/kg dose of fluconazole for the prophylaxis of invasive candidiasis in this patient population.