ADMINISTRATION OF THE ANTIMYCOTIC AGENTS FLUCONAZOLE AND ITRACONAZOLETO LEUKEMIA PATIENTS - A COMPARATIVE PHARMACOKINETIC STUDY

This report presents the results of a randomized parallel design compa rative study of the serum concentrations of fluconazole and itraconazo le after administration of 100 mg orally to patients with leukaemia, E ach group consisted of ten patients The antimycotic drugs were adminis tered with a standard breakfast immediately before the start of chemot herapy (day one) and on days eight and fifteen. No significant differe nces (p > 0.05; ANOVA) in the pharmacokinetic parameters of fluconazol e (AUC, C(max), T(max)) were found during the three days of the trial. It is concluded that there is no clinically important pharmacokinetic interaction between fluconazole and the chemotherapeutic agents given to this group of patients. A pharmacokinetic interaction between fluc onazole and the fever suffered by some of the patients also seems unli kely. No significant differences (p > 0.05: ANOVA) in the pharmacokine tic parameters of itraconazole (AUC, C(max), T(max)) were found during the three days of the trial, although the statistical power of the da ta was low. The significantly greater variability of all pharmacokinet ic parameters for itraconazole than for fluconazole and the sharp incr eases and decreases in AUC during the course of the trial found for so me patients in the itraconazole group suggest the need for caution in this group of patients.