Weekly treatment with oral fluconazole for 6 months appears to prevent recurrent symptomatic vulvovaginal candidiasis in many women, although it fails to produce mycologic cure in a significant percentage, Dr. Jack Sobel and associates reported.
"Two populations of patients ... can be identified: those in whom yeast eradication occurs and those in whom organisms persist in low numbers, only to increase when prophylaxis is stopped." said Dr. Sobel of Wayne State University, Detroit, and his colleagues. "It is simplistic to attribute this phenomenon only to the properties of the azole agent, since undefined characteristics of the host and the microorganisms may contribute to persistence in spite of inhibitory drug concentrations."
Still, the investigators noted, the regimen kept almost half the women in his randomized, controlled trial disease-free, even 6 months after it ended. The regimen was also safe, very well tolerated, and not associated with the development of any fluconazole-resistant yeast strains (N. Engl. J. Med. 351[9]:876-83, 2004).
The investigators enrolled almost 500 women whose acute symptomatic vulvovaginal candidiasis was preceded by a recurrent history of the infection. All women received three sequential 150-mg doses of oral fluconazole at 72-hour intervals.
Women who were clinically cured were randomized to either placebo or the study therapy: a 6-month course of once-weekly 150-mg oral fluconazole. After the therapy period, the women received follow-up visits at months 9 and 12.
Each follow-up visit included a clinical history, pelvic exam, and vaginal fungal culture.
A total of 373 women were randomized. The patients average age was 34 years: 94% were infected with Candida albicans and 13% with C. glabrata.
After the 6-month treatment period, 91% of the study patients were well, without a clinical occurrence of the infection, compared with 36% of the placebo patients.
By month 12, 43% of the study group remained clinically cured, compared with 22% of the placebo group.
Recurrence was seen in 57% of the study group and in 78% of the placebo group. Mean time to first relapse was 8.4 months after randomization in the study group, compared with 2 months in the placebo group.
Mycologic eradication or suppression occurred in 82% of the study group and 28% of the placebo group after the treatment period.
No fluconazole-resistant strains of C. albicans were identified in either group, and there were no changes in the minimum inhibitory concentration values for the drug.
About 4% of patients reported at least one adverse event, but only one--a headache--was thought to be related to the study drug. Liver function tests, which were performed at the end of the induction phase and twice during the treatment phase, identified only one patient with a mildly elevated aminotransferase level.
Although the prophylactic treatment regimen appears to be safe and effective, questions remain, Dr. David Eschenbach wrote in an accompanying editorial (N. Engl. J. Med. 351[9]:851-52, 2004). "The optimum duration of suppressive therapy is unknown, and the pathophysiology of chronic, recurrent vulvovaginal candidiasis remains unclear," said Dr. Eschenbach of the University of Washington, Seattle. "Some patients with persistent Candida infection did not have recurrent symptomatic disease, whereas other patients in whom cultures showed no Candida had recurrent symptoms.
"Further work is required to eradicate this troublesome condition, but the current report describes an effective treatment strategy for the time being," he concluded.
BY MICHELE G. SULLIVAN
Mid-Atlantic Bureau
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2004 Gale Group
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