Efficacy and safety of miconazole muco-adhesive tablet versus itraconazole in oropharyngeal candidiasis: A randomized, multi-centered, double-blind, phase 3 trial

医学 咪康唑 伊曲康唑 内科学 安慰剂 临床终点 不利影响 随机对照试验 临床试验 胃肠病学 置信区间 外科 皮肤病科 抗真菌 病理 替代医学
作者
Yufeng Wang,Haiwen Zhou,Wenmei Wang,Ning Duan,Zhixiao Luo,Hongbo Chai,Lu Jiang,Qianming Chen,Jinli Liu,Hong Hua,Zhimin Yan,Fan Yuan,Juanyong Xu,Xiaobing Guan,Hongjian Wang,Hongzhou Lu,Wenhui Lun,Fei Wei,Tong Zhang,Jizhi Zhao
出处
期刊:Medical Mycology [Oxford University Press]
卷期号:60 (11) 被引量:2
标识
DOI:10.1093/mmy/myac076
摘要

Abstract Oropharyngeal candidiasis (OPC) is an opportunistic infection treated with anti-fungal agents. Herein, we evaluate the efficacy and safety of miconazole buccal tablets (MBT) and itraconazole capsules in the localized treatment of patients with OPC. In this multi-centered, double-blinded, phase III trial (CTR20130414), both males and non-pregnant females (≥18 years) with OPC were randomized (1:1) to MBT plus placebo (experimental group) or itraconazole capsules plus placebo (control group). The primary endpoint was clinical cure at the end-of-treatment period [visit 4 (V4)] while secondary endpoints were clinical remission rates, partial remission rates, mycological cure, clinical relapse, and adverse events (AEs). All endpoints were statistically analyzed in both the full analysis set (FAS) and per-protocol (PP) set. A total of 431 (experimental: 216; control: 215) subjects were included. At V4, in the FAS set, the clinical cure was achieved in 68% and 59% patients in experimental and control groups, respectively with a treatment difference of 9% [95% confidence interval (CI): −1,19; P < .001] demonstrating non-inferiority of MBT over itraconazole. At V4, mycological cure rates were 68.2% and 42.0% in the experimental group and control groups (P < .001), respectively in FAS. The relapse rates were 5.4% and 6.6%, respectively, in the experimental and control groups. A total of 210 patients experienced AEs during treatment with 47.7% in the experimental group and 49.8% in the control group with no deaths. This study demonstrated that once-daily treatment with MBT was non-inferior to itraconazole with higher mycological cure rates and was tolerable with mild AE in patients with OPC.
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