Efficacy and safety of ensifentrine in treatment of COPD: a systematic review and meta-analysis of clinical trials.

IF 3.3 3区医学 Q2 RESPIRATORY SYSTEM

Therapeutic Advances in Respiratory Disease Pub Date : 2025-01-01 Epub Date: 2025-06-20 DOI:10.1177/17534666251347775

Bara M Hammadeh, Osama M Younis, Muaath I Alsufi, Muhammad Idrees, Ayham Mohammad Hussein, Abdullah Yousef Aldalati, Fares A Qtaishat, Banan Qatawneh, Al Bugazia, Raed A Hamed

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引用次数: 0

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a progressive lung disease marked by airway inflammation and obstruction. Ensifentrine is a novel inhaled PDE3 and PDE4 inhibitor with both bronchodilator and anti-inflammatory effects.

Objectives: Comprehensively review the available evidence on ensifentrine and its potential role in COPD management.

Design: Systematic review and meta-analysis with trial sequential analysis of randomized clinical trials.

Data sources and methods: We systematically searched PubMed, Scopus, ScienceDirect, Cochrane Library, and Medline for clinical trials published between 2018 and August 2024 that evaluated the safety and efficacy of ensifentrine in patients with COPD. We assessed study quality using the RoB 2 tool and conducted the meta-analysis with the "meta" package in R (version 4.3.2), using the mean difference with a 95% confidence interval to evaluate changes in outcomes.

Results: Five studies met the predefined inclusion criteria with 2519 participants. At week 12, the pooled analysis indicated that forced expiratory volume in 1 s (FEV₁) and trough FEV₁ were significantly increased in the ensifentrine group (mean difference (MD): 91.32; 95% CI: 69.63 to 113.01) and (MD: 40.90; 95% CI: 19.65 to 62.15), respectively. At week 24, the pooled analysis indicated that the evaluating respiratory symptoms total score was significantly decreased in the ensifentrine group (MD: -0.81; 95% CI: -1.36 to -0.27), transition dyspnea index score was significantly increased in the ensifentrine group (MD: 0.96; 95% CI: 0.62 to 1.29), no significant difference was observed in rescue medication use (MD: -0.30; 95% CI: -0.60 to 0.00), and no significant difference was observed in St. George's Respiratory Questionnaire total score (MD: -1.46; 95% CI: -3.22 to 0.30). Based on subgroup analysis, higher doses were associated with more favorable results.

Conclusion: In conclusion, owing to its dual effects, ensifentrine has a significant impact on improving pulmonary function and quality of life with minimal side effects. Promising results are expected if implied by synergizing with other drugs, however, more studies are needed to study the long-term effect on disease progression.

Trial registration: The study protocol was published via PROSPERO: International Prospective Register of Systematic Reviews (#CRD42024570799).

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恩西芬汀治疗慢性阻塞性肺病的疗效和安全性：临床试验的系统回顾和荟萃分析。

背景：慢性阻塞性肺疾病（COPD）是一种以气道炎症和阻塞为特征的进行性肺部疾病。Ensifentrine是一种新型的吸入式PDE3和PDE4抑制剂，具有支气管扩张和抗炎作用。目的：全面回顾关于恩西芬汀及其在COPD治疗中的潜在作用的现有证据。设计：随机临床试验的系统评价和荟萃分析。数据来源和方法：我们系统地检索了PubMed、Scopus、ScienceDirect、Cochrane Library和Medline，检索了2018年至2024年8月期间发表的临床试验，这些试验评估了ensifentrine对COPD患者的安全性和有效性。我们使用RoB 2工具评估研究质量，并使用R（4.3.2版）中的“meta”软件包进行meta分析，使用95%置信区间的平均差异来评估结果的变化。结果：有5项研究符合预定的纳入标准，共有2519名受试者。12周时，合并分析结果显示，埃斯芬汀组1 s用力呼气量（FEV1）和过FEV1显著升高(平均差值（MD）： 91.32；95% CI: 69.63 ~ 113.01)和(MD: 40.90；95% CI: 19.65 ~ 62.15)。在第24周，合并分析表明，评价呼吸系统症状总分在烯西芬汀组显著降低(MD: -0.81；95% CI: -1.36 ~ -0.27)，过渡期呼吸困难指数评分在烯西芬汀组显著升高(MD: 0.96；95% CI: 0.62 ~ 1.29)，在抢救用药方面无显著差异(MD: -0.30；95% CI: -0.60 ~ 0.00)，圣乔治呼吸问卷总分无显著差异(MD: -1.46；95% CI: -3.22至0.30)。基于亚组分析，高剂量与更有利的结果相关。结论：综上所述，由于具有双重作用，恩西芬汀在改善肺功能和生活质量方面具有显著作用，且副作用最小。如果与其他药物协同作用，预期会有很好的结果，然而，需要更多的研究来研究对疾病进展的长期影响。试验注册：该研究方案通过普洛斯彼罗：国际前瞻性系统评价注册（#CRD42024570799）发布。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutic Advances in Respiratory Disease RESPIRATORY SYSTEM-

CiteScore

6.90

自引率

0.00%

发文量

审稿时长

15 weeks

期刊介绍： Therapeutic Advances in Respiratory Disease delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of respiratory disease.