Hitt Emily M, Powell Alexa J
Department of Pharmacotherapy, Washington State University College of Pharmacy and Pharmaceutical Sciences, Spokane, WA, USA.
J Pharm Technol. 2025 Jun 24:87551225251350899. doi: 10.1177/87551225251350899.
The goals of this article are reviewing the clinical aspects of ensifentrine, results from the clinical trials that led to its approval and examining its potential impact on patient care to aid therapeutic decision-making. A literature search of studies took place between October 2024 and December 2024 on PubMed using the terms and chronic obstructive pulmonary disease (COPD). Phase II and III randomized controlled trials were eligible for inclusion. Pertinent clinical trials included those focusing on the use of ensifentrine in the treatment of COPD. Meeting abstracts, systematic reviews and meta-analyses were excluded from this article. Food and Drug Administration approval for ensifentrine is based off the phase III ENHANCE clinical trials in patients with COPD. Ensifentrine demonstrated improvement in lung function and a reduction in symptoms in clinical studies with a tolerable safety profile. The development and approval of ensifentrine for the maintenance of COPD demonstrates an advancement in patient care for a disease with significant morbidity and mortality. Ensifentrine could be a viable option as adjunct therapy for patients still experiencing symptoms despite treatment with currently recommended therapies.
本文的目的是回顾恩昔芬净的临床情况、促成其获批的临床试验结果,并探讨其对患者护理的潜在影响,以辅助治疗决策。2024年10月至12月期间,在PubMed上使用恩昔芬净和慢性阻塞性肺疾病(COPD)等术语进行了文献检索。符合纳入标准的为II期和III期随机对照试验。相关临床试验包括那些聚焦于恩昔芬净用于治疗COPD的试验。会议摘要、系统评价和荟萃分析均被排除在本文之外。美国食品药品监督管理局对恩昔芬净的批准基于针对COPD患者的III期ENHANCE临床试验。在临床研究中,恩昔芬净显示出肺功能改善、症状减轻,且安全性良好。恩昔芬净用于COPD维持治疗的研发和获批表明,针对一种具有显著发病率和死亡率的疾病,患者护理取得了进展。对于尽管接受了当前推荐疗法治疗仍有症状的患者,恩昔芬净可能是一种可行的辅助治疗选择。