Journal of women's health (2002) · 2025
Sustained Efficacy of Oteseconazole in Women with Recurrent Vulvovaginal Candidiasis.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Lederman Samuel N, Sobel Ryan, Sobel Jack D, Curelop Stacey B, Brand Stephen R
Аннотация
BACKGROUND: Recurrent vulvovaginal candidiasis (RVVC) is defined as 3 or more acute symptomatic episodes in a year and affects nearly 138 million women globally. Oteseconazole selectively inhibits fungal cytochrome P51 and has potent activity against Candida albicans and resistant species, including C. glabrata and fluconazole-resistant strains. Over 90% of women randomized to receive oteseconazole in two recently completed global Phase 3 clinical trials (VIOLET trials) did not experience a RVVC episode during these 48-week clinical studies. This observational study was designed to extend these initial findings.
PATIENTS AND METHODS: A total of 70 eligible women previously randomized to receive oteseconazole were enrolled into an extension study and were followed an additional 48 weeks and monitored for recurrent infections. No additional investigational treatment was administered during the observational period.
RESULTS: Of the 70 eligible study participants who received oteseconazole, 85% completed the extension study, and 1/70 (1.4%) experienced a culture-verified recurrent infection during the observational period, weeks 48 to 96. Of the participants initially randomized to receive placebo, 76% completed the study and 3/17 (17.6%) experienced a recurrent infection during the extension study. The proportion of participants who prematurely discontinued the study was lower in the oteseconazole-treated group (16%) compared with the placebo group (29%).
CONCLUSIONS: During the 48-week extension study, 1.4% of previously randomized subjects experienced a culture-positive recurrence of symptomatic vulvovaginal candidiasis, demonstrating a continued long-term protective effect of oteseconazole.
PATIENTS AND METHODS: A total of 70 eligible women previously randomized to receive oteseconazole were enrolled into an extension study and were followed an additional 48 weeks and monitored for recurrent infections. No additional investigational treatment was administered during the observational period.
RESULTS: Of the 70 eligible study participants who received oteseconazole, 85% completed the extension study, and 1/70 (1.4%) experienced a culture-verified recurrent infection during the observational period, weeks 48 to 96. Of the participants initially randomized to receive placebo, 76% completed the study and 3/17 (17.6%) experienced a recurrent infection during the extension study. The proportion of participants who prematurely discontinued the study was lower in the oteseconazole-treated group (16%) compared with the placebo group (29%).
CONCLUSIONS: During the 48-week extension study, 1.4% of previously randomized subjects experienced a culture-positive recurrence of symptomatic vulvovaginal candidiasis, demonstrating a continued long-term protective effect of oteseconazole.