The safety of itraconazole in the diabetic population

This study examined the safety of itraconazole for the treatment of onychom ycosis in patients with diabetes mellitus compared with standard palliative treatment. Fifty-two diabetic subjects in a large Veterans Affairs health system who had been diagnosed as having lower-extremity complications and d istal dermatophytic subungual onychomycosis of the toenail were randomized to receive either intermittent itraconazole, 200 mg twice daily, or standar d palliative care, consisting of toenail trimming, cleaning, and soaking. A dverse events were reported in 4 of the 27 itraconazole subjects; no advers e events were reported in the 25 palliative treatment subjects. One itracon azole subject was withdrawn from the study because of elevated liver functi on test results; the other three adverse events (rash, diarrhea, and pedal edema) were considered self-limiting and did not interfere with protocol co mpletion. Analyses of prestudy and poststudy hemoglobin A(1c) and liver fun ction test results in both treatment groups were comparable, with no statis tically significant differences. Itraconazole was found to be safe for the treatment of distal dermatophytic subungual onychomycosis in diabetic patie nts with lower-extremity complications having multiple concomitant disorder s and requiring concurrent pharmacologic regimens.