« Back

Micafungin as effective as amphotericin B in treating pediatric patients with invasive candidiasis, less toxic, data show

Wednesday, September 10 2008 | Comments

---

What's This? Micafungin sodium is as effective as liposomal amphotericin B in treating invasive candidiasis in pediatric patients, according to the results of a substudy, and micafungin appears to have a safety advantage relative to liposomal amphotericin B in this population.

The pediatric substudy, which was part of a double-blind, multinational trial, included 106 patients aged <16 years with clinical signs of systemic Candida infection and at least 1 positive Candida culture within the 4 days prior to enrollment. More than half of the patients (n=57) were aged <2 years, and 19 of these patients had been born prematurely.

The patients were randomized to treatment with micafungin 2 mg/kg or liposomal amphotericin B 3 mg/kg as a first-line therapy. The study's primary endpoint was response rate, which was based on the investigator's assessment of overall treatment success and required both a clinical and mycologic response at the end of therapy.

The patients who received micafungin had a treatment success rate of 72.9%, which was similar to the success rate of 76% for the patients who received amphotericin B, with an adjusted difference between the groups of only -2.4% (95% CI, -20.1% to 15.3) when the subjects were stratified by neutropenic status.

Even after adjusting for neutropenic status, the age of the participant, and whether the patient had been born prematurely, the efficacy results remained similar.

A significantly higher proportion of the patients in the amphotericin B arm withdrew from the study because of adverse events as compared with the micafungin arm (16.7% vs 3.8%; P=.05).

"The results of this pediatric substudy are consistent with those of the large adult study, which demonstrated noninferiority of micafungin relative to amphotericin B and a significantly better safety profile," the authors noted. "This smaller substudy provides evidence that micafungin is effective and safe in the pediatric population," they concluded. (Queiroz-Telles F, et al. Ped Infect Dis J 2008;27:820-826.)

Print  |  E-mail