PMID- 36149321
OWN - NLM
STAT- MEDLINE
DCOM- 20230928
LR  - 20230928
IS  - 1460-2709 (Electronic)
IS  - 1369-3786 (Linking)
VI  - 60
IP  - 11
DP  - 2022 Nov 3
TI  - Efficacy and safety of miconazole muco-adhesive tablet versus itraconazole in 
      oropharyngeal candidiasis: A randomized, multi-centered, double-blind, phase 3 
      trial.
LID - myac076 [pii]
LID - 10.1093/mmy/myac076 [doi]
AB  - 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.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of The 
      International Society for Human and Animal Mycology.
FAU - Wang, Yufeng
AU  - Wang Y
AD  - Department of Oral Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong 
      University School of Medicine; College of Stomatology, Shanghai Jiao Tong 
      University; National Stomatological Center; National Clinical Research Center for 
      Oral Diseases; Shanghai Key Laboratory, Shanghai 200011, China.
FAU - Zhou, Haiwen
AU  - Zhou H
AD  - Department of Oral Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong 
      University School of Medicine; College of Stomatology, Shanghai Jiao Tong 
      University; National Stomatological Center; National Clinical Research Center for 
      Oral Diseases; Shanghai Key Laboratory, Shanghai 200011, China.
FAU - Wang, Wenmei
AU  - Wang W
AD  - Department of Oral Medicine, Nanjing Stomatological Hospital, Medical School of 
      Nanjing University, Nanjing 210008, Jiangsu, China.
FAU - Duan, Ning
AU  - Duan N
AD  - Department of Oral Medicine, Nanjing Stomatological Hospital, Medical School of 
      Nanjing University, Nanjing 210008, Jiangsu, China.
FAU - Luo, Zhixiao
AU  - Luo Z
AD  - Dental Department, Taihe Hospital, Affiliated Hospital of Hubei, University of 
      Medicine, Shiyan 442099, Hubei, China.
FAU - Chai, Hongbo
AU  - Chai H
AD  - Dental Department, Taihe Hospital, Affiliated Hospital of Hubei, University of 
      Medicine, Shiyan 442099, Hubei, China.
FAU - Jiang, Lu
AU  - Jiang L
AD  - Department of Oral Medicine, West China School/Hospital Stomatology Sichuan 
      University, Chengdu 610042, Sichuan, China.
FAU - Chen, Qianming
AU  - Chen Q
AD  - Department of Oral Medicine, West China School/Hospital Stomatology Sichuan 
      University, Chengdu 610042, Sichuan, China.
FAU - Liu, Jinli
AU  - Liu J
AD  - Department of Oral Medicine, West China School/Hospital Stomatology Sichuan 
      University, Chengdu 610042, Sichuan, China.
FAU - Hua, Hong
AU  - Hua H
AD  - Department of Oral Medicine, Peking University School and Hospital of 
      Stomatology, Beijing 100081, China.
FAU - Yan, Zhimin
AU  - Yan Z
AD  - Department of Oral Medicine, Peking University School and Hospital of 
      Stomatology, Beijing 100081, China.
FAU - Fan, Yuan
AU  - Fan Y
AD  - Department of Oral Medicine, Affiliated Hospital of Stomatology, Nanjing Medical 
      University, Nanjing 210029, Jiangsu, China.
FAU - Xu, Juanyong
AU  - Xu J
AD  - Department of Oral Medicine, Affiliated Hospital of Stomatology, Nanjing Medical 
      University, Nanjing 210029, Jiangsu, China.
FAU - Guan, Xiaobing
AU  - Guan X
AD  - Department of Oral Medicine, Beijing Stomatological Hospital, Capital Medical 
      University, Beijing 100050, China.
FAU - Wang, Hongjian
AU  - Wang H
AD  - Department of Oral Medicine, Beijing Stomatological Hospital, Capital Medical 
      University, Beijing 100050, China.
FAU - Lu, Hongzhou
AU  - Lu H
AD  - Department of Infectious Diseases and Immunology, Shanghai Public Health Clinical 
      Center, Fudan University, Shanghai 201508, China.
FAU - Lun, Wenhui
AU  - Lun W
AD  - Department of Dermatology and Venereology, Beijing Ditan Hospital, Capital 
      Medical University, Beijing 100015, China.
FAU - Fei, Wei
AU  - Fei W
AD  - Department of Stomatology, Sichuan Academy of Medical Science & Sichuan 
      Provincial People's Hospital, Chengdu 610072, Sichuan, China.
FAU - Zhang, Tong
AU  - Zhang T
AD  - Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, 
      Capital Medical University, Beijing 100069, China.
FAU - Zhao, Jizhi
AU  - Zhao J
AD  - Department of Stomatology, Peking Union Medical College Hospital, Beijing 100730, 
      China.
FAU - Jia, Chunling
AU  - Jia C
AD  - Department of Oral Medicine, Qilu Hospital of Shandong University, Jinan 250012, 
      Shandong, China.
FAU - Kong, Hui
AU  - Kong H
AD  - State Key Laboratory of Military Stomatology & National Clinical Research Center 
      for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, 
      Department of Oral Medicine, Department of Operative Dentistry & Endodontics, 
      School of Stomatology, The Fourth Military Medical University, Xi'an, 710032, 
      Shaanxi, China.
FAU - Shen, Xuemin
AU  - Shen X
AD  - Department of Oral Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong 
      University School of Medicine; College of Stomatology, Shanghai Jiao Tong 
      University; National Stomatological Center; National Clinical Research Center for 
      Oral Diseases; Shanghai Key Laboratory, Shanghai 200011, China.
FAU - Liu, Qing
AU  - Liu Q
AD  - State Key Laboratory of Military Stomatology & National Clinical Research Center 
      for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, 
      Department of Oral Medicine, Department of Operative Dentistry & Endodontics, 
      School of Stomatology, The Fourth Military Medical University, Xi'an, 710032, 
      Shaanxi, China.
FAU - Wang, Weizhi
AU  - Wang W
AD  - Department of Oral Medicine, Qilu Hospital of Shandong University, Jinan 250012, 
      Shandong, China.
FAU - Tang, Guoyao
AU  - Tang G
AUID- ORCID: 0000-0002-8132-5178
AD  - Department of Oral Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong 
      University School of Medicine; College of Stomatology, Shanghai Jiao Tong 
      University; National Stomatological Center; National Clinical Research Center for 
      Oral Diseases; Shanghai Key Laboratory, Shanghai 200011, China.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Med Mycol
JT  - Medical mycology
JID - 9815835
RN  - 0 (Adhesives)
RN  - 0 (Antifungal Agents)
RN  - 304NUG5GF4 (Itraconazole)
RN  - 7NNO0D7S5M (Miconazole)
RN  - 0 (Tablets)
SB  - IM
MH  - Female
MH  - Male
MH  - Adhesives/therapeutic use
MH  - Antifungal Agents/adverse effects
MH  - *Candidiasis, Oral/drug therapy/veterinary
MH  - Double-Blind Method
MH  - Itraconazole/adverse effects
MH  - *Miconazole/adverse effects
MH  - Recurrence
MH  - Tablets/therapeutic use
OAB - Miconazole is an antifungal drug against certain types of fungus or yeast 
      infections. In this study, we showed that treatment with once-daily miconazole 
      buccal tablets was as effective as systemic itraconazole capsules in Chinese 
      patients infected by oropharyngeal candidiasis with minimum side effects.
OABL- eng
OTO - NOTNLM
OT  - antifungal agent
OT  - itraconazole
OT  - miconazole
OT  - mycological cure rates
OT  - oropharyngeal candidiasis
EDAT- 2022/09/24 06:00
MHDA- 2022/11/08 06:00
CRDT- 2022/09/23 09:53
PHST- 2021/11/29 00:00 [received]
PHST- 2022/06/16 00:00 [revised]
PHST- 2022/09/21 00:00 [accepted]
PHST- 2022/09/24 06:00 [pubmed]
PHST- 2022/11/08 06:00 [medline]
PHST- 2022/09/23 09:53 [entrez]
AID - 6712336 [pii]
AID - 10.1093/mmy/myac076 [doi]
PST - ppublish
SO  - Med Mycol. 2022 Nov 3;60(11):myac076. doi: 10.1093/mmy/myac076.