Calzetta Luigino, Cazzola Mario, Gholamalishahi Shima, Rogliani Paola
Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Parma, Italy.
Department of Experimental Medicine, Unit of Respiratory Medicine, University of Rome "Tor Vergata", Rome, Italy.
Curr Res Pharmacol Drug Discov. 2024 Jul 6;7:100195. doi: 10.1016/j.crphar.2024.100195. eCollection 2024.
The investigation of ensifentrine, an inhaled dual phosphodiesterase (PDE)3 and PDE4 inhibitor, for chronic obstructive pulmonary disease (COPD) maintenance therapy presents a significant clinical interest. Despite promising results from recent Phase III trials, a comprehensive synthesis of its therapeutic efficacy in COPD is lacking. This protocol outlines the first registered systematic review and meta-analysis in PROSPERO to assess the impact of ensifentrine on trough forced expiratory volume in the 1st second (FEV) and acute exacerbations of COPD. By conducting a rigorous literature search and employing solid methodologies, this endeavour aims to provide robust evidence on the real efficacy of ensifentrine. Anticipated outcomes include a significant improvement in trough FEV and a reduction in AECOPD risk among ensifentrine-treated patients compared to controls, corroborating its bronchodilator and anti-inflammatory properties. The meta-analysis expects to reveal consistent results across different trials, enhancing confidence in the findings. Additionally, subgroup analyses may unveil factors influencing the efficacy of ensifentrine, guiding optimal therapeutic strategies. Overall, this protocol holds the potential to inform clinical practice and regulatory decisions, positioning ensifentrine as a valuable addition to COPD management.
吸入性双磷酸二酯酶（PDE）3和PDE4抑制剂恩昔芬净用于慢性阻塞性肺疾病（COPD）维持治疗的研究具有重大临床意义。尽管近期的III期试验取得了令人鼓舞的结果，但缺乏对其在COPD中治疗效果的全面综合分析。本方案概述了在国际前瞻性注册系统评价和荟萃分析平台（PROSPERO）上首次注册的系统评价和荟萃分析，以评估恩昔芬净对第1秒用力呼气容积（FEV₁）谷值和COPD急性加重的影响。通过进行严格的文献检索并采用可靠的方法，本研究旨在为恩昔芬净的实际疗效提供有力证据。预期结果包括与对照组相比，恩昔芬净治疗的患者FEV₁谷值显著改善，慢性阻塞性肺疾病急性加重（AECOPD）风险降低，证实其支气管扩张和抗炎特性。荟萃分析预计将揭示不同试验之间的一致结果，增强对研究结果的信心。此外，亚组分析可能会揭示影响恩昔芬净疗效的因素，指导最佳治疗策略。总体而言，本方案有可能为临床实践和监管决策提供参考，将恩昔芬净定位为COPD管理中有价值的补充药物。
