Background The cornerstone medications for maintenance of chronic obstructive pulmonary disease (COPD) have remained the same for decades. Despite combination therapy with multiple mechanisms of action, patients with COPD have significant morbidity and frequent exacerbations. New treatments with novel mechanisms of action are needed to decrease exacerbation and improve symptoms. Ensifentrine is a novel dual PDE 3 and 4 inhibitor emerged and established as a promising drug in the treatment and management of COPD. Objectives The purpose of this study was to examine the pooled efficacy and safety of ensifentrine versus placebo for treatment of moderate to severe COPD. Data sources We explored PubMed, MEDLINE, and Cochrane Library databases. Study eligibility criteria Randomized controlled clinical trials (RCTs)comparing ensifentrine 3 mg twice daily to placebo for treating moderate-to-severe COPD were included. Design and method A systematic review of three RCTs investigating the use of ensifentrine in adults with moderate to severe COPD was performed. Mean and risk differences with 95% confidence intervals (CI) were used to express the pooled effect on continuous and binary outcomes, respectively. Results This systematic review included data from three randomized controlled trials encompassing a total of 1,715 patients. Of these, 1,057 patients received ensifentrine and 658 received placebo. Ensifentrine was associated with significant improvements in all primary outcomes compared to placebo. The pooled mean differences in peak FEV₁, average FEV₁, and morning trough FEV₁ were 143.91 mL, 91.71 mL, and 43.69 mL, respectively (all p 0.05). Regarding secondary outcomes, ensifentrine significantly improved respiratory symptom scores assessed by the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) tool ( p = 0.02), as well as the Transition Dyspnea Index (TDI) score ( p 0.001). The incidence of adverse events was comparable between the ensifentrine and placebo groups. Conclusion Ensifentrine consistently improved pulmonary function tests and symptom scores with a safe adverse effect profile. This systematic review supports the clinical benefits of ensifentrine in patients with moderate to severe COPD.
Almuntashiri et al. (Fri,) studied this question.