"Oteseconazole versus fluconazole for the treatment of severe vulvovaginal candidiasis: a multicenter, randomized, double-blinded, phase 3 trial"

作者全名："Wang, Xiaoqian; Chen, Lihong; Ruan, Hongjie; Xiong, Zhengai; Wang, Wenying; Qiu, Jin; Song, Weihua; Zhang, Chunlian; Xue, Fengxia; Qin, Tianhua; Zhang, Bei; An, Ruifang; Luo, Xiping; Wang, Wei; Zhang, Songling; Cai, Yunlang; Kang, Jiali; Deng, Henan; Fan, Shangrong; Cui, Manhua; Wang, Shijin; Luo, Xiaowan; Su, Zhiying; Shu, Jing; Wang, Quanren; Wang, Fang; Bai, Jianling; Liao, Qinping; Krysan, Damian J."

作者地址："[Wang, Xiaoqian; Liao, Qinping] Tsinghua Univ, Sch Clin Med, Beijing Tsinghua Changgung Hosp, Dept Pathol, Beijing, Peoples R China; [Chen, Lihong] Shaanxi Prov Peoples Hosp, Dept Gynecol, Xian, Peoples R China; [Ruan, Hongjie] Nanjing Med Univ, Nanjing Matern & Child Hlth Care Hosp, Dept Gynecol, Womens Hosp, Nanjing, Peoples R China; [Xiong, Zhengai] Second Affiliated Hosp Chongqing Med Univ, Dept Obstet & Gynecol, Chongqing, Peoples R China; [Wang, Wenying] First Affiliated Hosp Xian Jiaotong Univ, Dept Reprod Med, Xian, Peoples R China; [Qiu, Jin] Shanghai Jiao Tong Univ, Sch Med, Ren Ji Hosp, Dept Obstet & Gynecol, Shanghai 200001, Peoples R China; [Song, Weihua] Women & Childrens Hlth Care Hosp Linyi, Dept Gynecol, Linyi, Shandong, Peoples R China; [Zhang, Chunlian] Hubei Univ Med, Taihe Hosp, Dept Oncol, Affiliated Hosp, Shiyan, Peoples R China; [Xue, Fengxia] Tianjin Med Univ, Gen Hosp, Dept Radiol, Tianjin, Peoples R China; [Qin, Tianhua] Urumqi Maternal & Child Hlth Care Hosp, Xinjiang Uygur Autonomous Reg, Urumqi, Peoples R China; [Zhang, Bei] Xuzhou Cent Hosp, Dept Gynecol & Obstet, Xuzhou, Peoples R China; [An, Ruifang] First Affiliated Hosp Xian Jiaotong Univ, Dept Neurol, Xian, Peoples R China; [Luo, Xiping] Guangdong Women & Children Hosp, Dept Gynecol, Guangzhou, Peoples R China; [Wang, Wei] Peking Univ Third Hosp, Dept Obstet & Gynecol, Beijing, Peoples R China; [Zhang, Songling] First Hosp Jilin Univ, Dept Obstet & Gynecol, Changchun, Peoples R China; [Cai, Yunlang] Zhongda Hosp Southeast Univ, Dept Obstet & Gynecol, Nanjing 210009, Peoples R China; [Kang, Jiali] Guangzhou First peoples Hosp, Dept Obstet & Gynecol, Guangzhou, Peoples R China; [Deng, Henan] First Peoples Hosp Chenzhou, Dept Obstet, Chenzhou, Peoples R China; [Fan, Shangrong] Peking Univ, Shenzhen Hosp, Dept Obstet & Gynecol, Shenzhen, Peoples R China; [Cui, Manhua] Second Hosp Jilin Univ, Dept Obstet & Gynecol, Changchun, Peoples R China; [Wang, Shijin] First Affiliated Hosp Xinxiang Med Univ, Dept Cardiol, Xinxiang, Peoples R China; [Luo, Xiaowan] Boai Hosp Zhongshan, Dept Gynecol, Zhongshan, Peoples R China; [Su, Zhiying] Xiamen Univ, Women & Childrens Hosp, Sch Med, Dept Gynecol, Xiamen, Peoples R China; [Shu, Jing] Zhejiang Prov Peoples Hosp, Dept Reprod Endocrinol, Hangzhou, Zhejiang, Peoples R China; [Wang, Quanren; Wang, Fang] Jiangsu Hengrui Pharmaceut Co Ltd, Clin Res & Dev, Shanghai, Peoples R China; [Bai, Jianling] Nanjing Med Univ, Sch Publ Hlth, Dept Biostat, Nanjing, Peoples R China; Univ Iowa, Iowa City, IA USA"

通信作者："Liao, QP (通讯作者)，Tsinghua Univ, Sch Clin Med, Beijing Tsinghua Changgung Hosp, Dept Pathol, Beijing, Peoples R China."

来源：ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001124948400001

JCR分区：Q1

影响因子：4.9

年份：2024

卷号：68

期号：1

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：oteseconazole; Candida albicans; severe vulvovaginal candidiasis; fluconazole; Candida glabrata

摘要："Vulvovaginal candidiasis (VVC) is a common condition among women. Fluconazole remains the dominant treatment option for VVC. Oteseconazole is a highly selective inhibitor of fungal CYP51. This randomized, double-blinded, phase 3 trial was conducted to evaluate the efficacy and safety of oteseconazole compared with fluconazole in treating severe VVC. Female subjects presenting with vulvovaginal signs and symptoms score of >= 7 and positive Candida infection determined by potassium hydroxide test or Gram staining were randomly assigned to receive oteseconazole (600 mg on D1 and 450 mg on D2) or fluconazole (150 mg on D1 and D4) in a 1:1 ratio. The primary endpoint was the proportion of subjects achieving therapeutic cure [defined as achieving both clinical cure (absence of signs and symptoms of VVC) and mycological cure (negative culture of Candida species)] at D28. A total of 322 subjects were randomized and 321 subjects were treated. At D28, a statistically significantly higher proportion of subjects achieved therapeutic cure in the oteseconazole group than in the fluconazole group (66.88% vs 45.91%; P = 0.0002). Oteseconazole treatment resulted in an increased proportion of subjects achieving mycological cure (82.50% vs 59.12%; P < 0.0001) and clinical cure (71.25% vs 55.97%; P = 0.0046) compared with fluconazole. The incidence of treatment-emergent adverse events was similar between the two groups. No subjects discontinued study treatment or withdrew study due to adverse events. Oteseconazole showed statistically significant and clinically meaningful superiority over fluconazole for the treatment of severe VVC and was generally tolerated."

基金机构：Jiangsu Hengrui Pharmaceuticals

基金资助正文："We sincerely thank all the subjects and their families, investigators, and investigational staff for participating in this study. We would like to acknowledge the contributions of Xiaopeng Wang (Jiangsu Hengrui Pharmaceuticals Co., Ltd) in the study design and Hao Yu (Department of Biostatistics, School of Public Health, Nanjing Medical University, China) in statistical analyses and outputs programming support. Medical writing support was provided by Haofeng Ding (Jiangsu Hengrui Pharmaceuticals Co., Ltd) per Good Publication Practice Guidelines."