Johnson City Medical Center, Ballad Health, Johnson City, TN, USA.
The University of Tennessee Health Science Center College of Pharmacy, Knoxville, TN, USA.
Ann Pharmacother. 2024 Jun;58(6):636-644. doi: 10.1177/10600280231195649. Epub 2023 Aug 31.
The objective of the study is to describe and analyze the pharmacodynamics and pharmacokinetics of oteseconazole as well as the clinical evidence supporting the efficacy of oteseconazole in treating recurrent vulvovaginal candidiasis (RVVC).
A literature search was conducted using MEDLINE and EMBASE databases (2015-June 2023). Search terms included "oteseconazole" OR "VT-1161" or "VIVJOA" AND "RVVC" or "recurrent vulvovaginal candidiasis" or "vulvovaginal candidiasis." Conference abstracts, bibliographies, clinical trials, and drug monographs were included for review.
Relevant studies in English and clinical trials conducted in humans were reviewed.
Oteseconazole is approved for the treatment of RVVC. In 2 identical phase III studies, oteseconazole was superior to placebo through 48 weeks for preventing recurrence of RVVC (6.7% vs 42.8%, < 0.001 and 3.9% vs 39.4%, < 0.001). In the only phase III trial comparing oteseconazole against active drug, oteseconazole was well tolerated and exhibited noninferiority to fluconazole in acute treatment and superiority to placebo for prevention maintenance through 50 weeks (5.1% vs 42.2%, < 0.001).
This review describes the use of oteseconazole for the treatment of RVVC as compared with fluconazole. Oteseconazole is an effective treatment option for common pathogens causing vulvovaginal candidiasis, including and fluconazole-resistant .
Oteseconazole is an effective and safe treatment option for the management of RVVC though current research lacks comparison with established maintenance regimens. Additional research is needed to ascertain the placement of oteseconazole in the treatment of RVVC.
本研究旨在描述和分析酮康唑的药效学和药代动力学，以及酮康唑治疗复发性外阴阴道念珠菌病（RVVC）的临床疗效证据。
使用 MEDLINE 和 EMBASE 数据库（2015 年 6 月至 2023 年）进行文献检索。检索词包括“酮康唑”或“VT-1161”或“VIVJOA”和“RVVC”或“复发性外阴阴道念珠菌病”或“外阴阴道念珠菌病”。纳入了会议摘要、参考文献、临床试验和药物专论进行综述。
综述了英文相关研究和在人类中进行的临床试验。
酮康唑已获批准用于治疗 RVVC。在 2 项相同的 III 期研究中，酮康唑在 48 周时预防 RVVC 复发的疗效优于安慰剂（6.7%对 42.8%，<0.001；3.9%对 39.4%，<0.001）。在唯一一项比较酮康唑与活性药物的 III 期试验中，酮康唑耐受良好，在急性治疗中与氟康唑非劣效，在 50 周预防维持治疗中优于安慰剂（5.1%对 42.2%，<0.001）。
与现有药物相比，对患者护理和临床实践的相关性：本综述描述了酮康唑治疗 RVVC 的用途，与氟康唑相比。酮康唑是治疗外阴阴道念珠菌病常见病原体的有效治疗选择，包括 和氟康唑耐药 。
酮康唑是治疗 RVVC 的有效和安全治疗选择，但目前的研究缺乏与既定维持方案的比较。需要进一步的研究来确定酮康唑在 RVVC 治疗中的地位。
