Two Fluconazole Doses Quell Severe Vaginal Candidiasis

OB/GYN News, Oct 15, 1999 by Mitchel L. Zoler

This advantage did not extend to women who had recurrent, nonsevere disease.

TORONTO -- Two doses of fluconazole led to significantly more short-term clinical responses in women with severe vaginal candidiasis, compared with a single dose in a controlled trial of 398 patients.

But this advantage for two doses, given 3 days apart, was not seen in women with recurrent, nonsevere disease.

In addition, among women with severe disease, the benefit of two doses waned over time, Dr. Jack D. Sobel reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Previous findings had indicated that women with severe or recurrent candidiasis had a worse response to a single dose of fluconazole than women with uncomplicated infections. Less than 10% of women with a vaginal Candida infection have severe or recurrent disease, noted Dr. Sobel, chief of the division of infectious diseases at Harper Hospital in Detroit.

The trial enrolled 398 women with recurrent and/or severe infections. Recurrent disease was defined as having four or more episodes during the prior 12 months. The mean number of episodes for all study participants was five; 54% had at least four episodes. Severity was assessed by a 15-point scale that gauged erythema, edema, excoriation, and symptom severity. Women with a score of 7 or greater were considered to have severe disease.

Patients were randomly selected to receive either one or two doses of 150 mg orally.

Among the patients with severe disease, the cure rate at 14 days after treatment was 73% among 103 women treated with a single dose and 86% among the 99 women treated with two doses, which is a statistically significant difference, Dr. Sobel reported at the meeting, which was also sponsored by the American College of Obstetricians and Gynecologists.

Thirty-five days after treatment, the cure rate was 60% among those who got one dose and 70% among the two-dose recipients, a difference that just missed statistical significance.

Analysis of a subset of 215 women with recurrent disease showed that although two doses produced slightly better cure rates, the differences were more modest and not significant.

Additional analysis showed that about 90% of these women were infected with Candida albicans and 10% with another species.

Compared with C. albicans, the nonalbicans species was much less responsive to fluconazole, regardless of what dosage was used, Dr. Sobel commented at the meeting.