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Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis.
N Engl J Med. 2004 Aug 26; 351(9):876-83.NEJM

Abstract

BACKGROUND

No safe and convenient regimen has proved to be effective for the management of recurrent vulvovaginal candidiasis.

METHODS

After inducing clinical remission with open-label fluconazole given in three 150-mg doses at 72-hour intervals, we randomly assigned 387 women with recurrent vulvovaginal candidiasis to receive treatment with fluconazole (150 mg) or placebo weekly for six months, followed by six months of observation without therapy. The primary outcome measure was the proportion of women in clinical remission at the end of the first six-month period. Secondary efficacy measures were the clinical outcome at 12 months, vaginal mycologic status, and time to recurrence on the basis of Kaplan-Meier analysis.

RESULTS

Weekly treatment with fluconazole was effective in preventing symptomatic vulvovaginal candidiasis. The proportions of women who remained disease-free at 6, 9, and 12 months in the fluconazole group were 90.8 percent, 73.2 percent, and 42.9 percent, as compared with 35.9 percent, 27.8 percent, and 21.9 percent, respectively, in the placebo group (P< 0.001). The median time to clinical recurrence in the fluconazole group was 10.2 months, as compared with 4.0 months in the placebo group (P<0.001). There was no evidence of fluconazole resistance in isolates of Candida albicans or of superinfection with C. glabrata. Fluconazole was discontinued in one patient because of headache.

CONCLUSIONS

Long-term weekly treatment with fluconazole can reduce the rate of recurrence of symptomatic vulvovaginal candidiasis. However, a long-term cure remains difficult to achieve.

Authors+Show Affiliations

Division of Infectious Diseases, Wayne State University School of Medicine, Detroit, USA. jsobel@med.wayne.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15329425

Citation

Sobel, Jack D., et al. "Maintenance Fluconazole Therapy for Recurrent Vulvovaginal Candidiasis." The New England Journal of Medicine, vol. 351, no. 9, 2004, pp. 876-83.
Sobel JD, Wiesenfeld HC, Martens M, et al. Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. N Engl J Med. 2004;351(9):876-83.
Sobel, J. D., Wiesenfeld, H. C., Martens, M., Danna, P., Hooton, T. M., Rompalo, A., Sperling, M., Livengood, C., Horowitz, B., Von Thron, J., Edwards, L., Panzer, H., & Chu, T. C. (2004). Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. The New England Journal of Medicine, 351(9), 876-83.
Sobel JD, et al. Maintenance Fluconazole Therapy for Recurrent Vulvovaginal Candidiasis. N Engl J Med. 2004 Aug 26;351(9):876-83. PubMed PMID: 15329425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. AU - Sobel,Jack D, AU - Wiesenfeld,Harold C, AU - Martens,Mark, AU - Danna,Penny, AU - Hooton,Thomas M, AU - Rompalo,Anne, AU - Sperling,Malcolm, AU - Livengood,Charles,3rd AU - Horowitz,Benson, AU - Von Thron,James, AU - Edwards,Libby, AU - Panzer,Helene, AU - Chu,Teng-Chiao, PY - 2004/8/27/pubmed PY - 2004/9/1/medline PY - 2004/8/27/entrez SP - 876 EP - 83 JF - The New England journal of medicine JO - N Engl J Med VL - 351 IS - 9 N2 - BACKGROUND: No safe and convenient regimen has proved to be effective for the management of recurrent vulvovaginal candidiasis. METHODS: After inducing clinical remission with open-label fluconazole given in three 150-mg doses at 72-hour intervals, we randomly assigned 387 women with recurrent vulvovaginal candidiasis to receive treatment with fluconazole (150 mg) or placebo weekly for six months, followed by six months of observation without therapy. The primary outcome measure was the proportion of women in clinical remission at the end of the first six-month period. Secondary efficacy measures were the clinical outcome at 12 months, vaginal mycologic status, and time to recurrence on the basis of Kaplan-Meier analysis. RESULTS: Weekly treatment with fluconazole was effective in preventing symptomatic vulvovaginal candidiasis. The proportions of women who remained disease-free at 6, 9, and 12 months in the fluconazole group were 90.8 percent, 73.2 percent, and 42.9 percent, as compared with 35.9 percent, 27.8 percent, and 21.9 percent, respectively, in the placebo group (P< 0.001). The median time to clinical recurrence in the fluconazole group was 10.2 months, as compared with 4.0 months in the placebo group (P<0.001). There was no evidence of fluconazole resistance in isolates of Candida albicans or of superinfection with C. glabrata. Fluconazole was discontinued in one patient because of headache. CONCLUSIONS: Long-term weekly treatment with fluconazole can reduce the rate of recurrence of symptomatic vulvovaginal candidiasis. However, a long-term cure remains difficult to achieve. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/15329425/Maintenance_fluconazole_therapy_for_recurrent_vulvovaginal_candidiasis_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa033114?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -