Maintenance Fluconazole Therapy for Recurrent Vulvovaginal Candidiasis
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.
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Although symptom resolution is achieved in ~90% of women with RVVC who undergo at least 6 months of maintenance therapy, up to 50% will have a recurrence after the termination of maintenance therapy.
“Although symptom resolution is achieved in ~90% of women with RVVC who undergo ⩾6 months of maintenance therapy,16,21,22 up to 50% will have a recurrence after the termination of maintenance therapy. 13”
From Clinical challenges in diagnosis and treatment of recurrent vulvovaginal candidiasis (2022) · cites this paper as [21]
A landmark RVVC treatment study using an induction regimen of fluconazole (three 150 mg doses at 72 h intervals) followed by weekly maintenance doses of 150 mg of fluconazole for 6 months was shown to reduce symptoms and recurrences.
“A landmark RVVC treatment study using an induction regimen of fluconazole (three 150 mg doses at 72 h intervals) followed by weekly maintenance doses of 150 mg of fluconazole for 6 months was shown to reduce symptoms and recurrences. 21”
From Clinical challenges in diagnosis and treatment of recurrent vulvovaginal candidiasis (2022) · cites this paper as [21]
The mainstay of treatment for most cases of uncomplicated VVC is azole antifungals, which inhibit the fungal enzyme CYP51 and prevent accumulation of fungitoxic sterols.
“The mainstay of treatment for most cases of uncomplicated VVC is azole antifungals, which, by inhibiting the fungal enzyme CYP51, prevent the accumulation of fungitoxic sterols [11,34].”
From Treatment of Vulvovaginal Candidiasis—An Overview of Guidelines and the Latest Treatment Methods (2023) · cites this paper as [34]
During treatment phases, relapse rates vary between 21%, 57.1%, and 71.9% at 12 months depending upon the characteristics of the therapeutic regimen used.
“During the treatment phases, relapse rates vary between 21% (Donders et al., 2008a), 57.1% (Sobel et al., 2004), and 71.9% (Bolouri et al., 2009) at 12 months depending upon the characteristics of the therapeutic regimen used, as described in Supplementary Tables 2 and 3 .”
From Management of recurrent vulvovaginal candidosis: Narrative review of the literature and European expert panel opinion (2022) · cites this paper as Sobel et al., 2004
Up to 50% of women with RVVC relapsed after stopping their maintenance therapy regimen.
“Likewise, other studies found that up to 50% of women with RVVC relapsed after stopping their maintenance therapy regimen (Sobel et al., 2004; Donders et al., 2008a) or that additional fluconazole therapy was continued for longer than 6 months due to either culture-confirmed VVC recurrence, microbiologically unconfirmed but clinically possible VVC recurrence, or due to patients’ preference to”
From Management of recurrent vulvovaginal candidosis: Narrative review of the literature and European expert panel opinion (2022) · cites this paper as Sobel et al., 2004
Over half of women relapsed after maintenance therapy with fluconazole was stopped.
“With the regimen proposed by Sobel et al. (Sobel et al., 2004) (150 mg of oral fluconazole or placebo once a week for 6 months, after a successful induction phase), 42.9% of 387 women were still disease free at 12 months, indicating over half relapsed after maintenance therapy with fluconazole was stopped.”
From Management of recurrent vulvovaginal candidosis: Narrative review of the literature and European expert panel opinion (2022) · cites this paper as Sobel et al., 2004
Median time to clinical and mycological relapse was 10.2 and 8.4 months, respectively.
“Median time to clinical and mycological relapse was 10.2 and 8.4 months, respectively.”
From Management of recurrent vulvovaginal candidosis: Narrative review of the literature and European expert panel opinion (2022) · cites this paper as Sobel et al., 2004
With the regimen proposed by Sobel et al., 42.9% of 387 women were still disease free at 12 months.
“With the regimen proposed by Sobel et al. (Sobel et al., 2004) (150 mg of oral fluconazole or placebo once a week for 6 months, after a successful induction phase), 42.9% of 387 women were still disease free at 12 months, indicating over half relapsed after maintenance therapy with fluconazole was stopped.”
From Management of recurrent vulvovaginal candidosis: Narrative review of the literature and European expert panel opinion (2022) · cites this paper as Sobel et al., 2004
Oral fluconazole is highly effective at reducing acute episodes during maintenance therapy, but long-term remission after stopping the regimen is only present in about half of patients.
“Although oral fluconazole is highly effective at reducing acute episodes during maintenance therapy, long-term remission after stopping the regimen is only present in about half of patients (Sobel et al., 2004; Donders et al., 2008a).”
From Management of recurrent vulvovaginal candidosis: Narrative review of the literature and European expert panel opinion (2022) · cites this paper as Sobel et al., 2004
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Microsatellite Marker Analysis as a Typing System for Candida glabrata
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Vaginitis in Nonpregnant Patients: ACOG Practice Bulletin Number 215
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Zinc prevents vaginal candidiasis by inhibiting expression of an inflammatory fungal protein
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Self-citationEfficacy and Safety of Oteseconazole in Recurrent Vulvovaginal Candidiasis
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Chronic vulvovaginal candidiasis: What we know and what we have yet to learn
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Species spectrum and antifungal susceptibility profile of vaginal isolates of Candida in Kuwait
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Vaginitis: Diagnosis and Management
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- Authors
- 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.
- Affiliations
- Wayne State University (US)
- University of Pittsburgh (US)
- Hennepin County Medical Center (US)
- University of Washington (US)
- Johns Hopkins University (US)
- Pfizer (United States) (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2004-08-26
- Volume
- 351
- Issue
- 9
- Pages
- 876-883
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2106311471
- Cited by
- 487
- References
- 21
- Citations by year
- 2026: 12 · 2025: 17 · 2024: 17 · 2023: 26 · 2022: 22 · 2021: 21 · 2020: 22 · 2019: 15 · 2018: 28 · 2017: 30 · 2016: 26 · 2015: 29 · 2014: 23 · 2013: 24 · 2012: 23
- FWCI
- 11.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Health Sciences › Medicine › Epidemiology › Urinary Tract Infections Management
- Keywords
- recurrent vulvovaginal candidiasis, fluconazole, maintenance therapy, Candida albicans, Candida glabrata, antifungal resistance, superinfection, recurrence prevention, clinical remission
- MeSH terms
- Administration, Oral, Adult, Antifungal Agents, Candida albicans, Candidiasis, Vulvovaginal, Double-Blind Method, Drug Administration Schedule, Female, Humans, Remission Induction, Time Factors, Vagina, Fluconazole, Logistic Models, Drug Resistance, Fungal, Candida glabrata, Secondary Prevention
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