Heart Lung. 2021 Oct 29;51:25-31. doi: 10.1016/j.hrtlng.2021.07.005. Online ahead of print.
ABSTRACT
BACKGROUND: Fixed-dose combination (FDC) of Aclidinium (ACL) and Formoterol (FOR) is a maintenance therapy for patients with stable chronic obstructive pulmonary disease (COPD). Although the effect of combination of long-acting beta-agonists (LABA) and long-acting muscarinic antagonists (LAMA) is less compared with the statistical sum of the effects of LABA and LAMA alone, the effect of combination of LABA and LAMA is significantly higher than that of either of the two. Thus, the resulting therapeutic effect in pulmonary function, improvement of dyspnea, quality of life, and incidence of adverse events was analyzed to explore the efficacy of FDC and monotherapy of either ACL or FOR in stable COPD patients.
METHODS: Methods Chronic obstructive pulmonary disease (COPD), aclidinium or LAMA, formoterol or LABA, randomized controlled trials, or RCT were used as keywords in the search for studies in PubMed, EMBASE, Cochrane Library, Reference List, and Clinicaltrails.gov databases. Studies that evaluated efficacy and side effects of Fixed-dose combination of Aclidinium/Formoterol and Monotherapy of Aclidinium or Formoterol in COPD published between the establishment period of the database and June 2020 were retrieved. Two independent reviewers extracted the data; Revman 5.3 software was used for data analysis with dose efficacy and side effects were presented as mean difference at 95% confidence interval. Notably, ACL 400 mg / FOR 12ug and ACL 400 mg / 6ug were used as subgroup analysis.
RESULTS: A total of 6 studies with 7,081 patients were enrolled for analysis. The trough forced expiratory volume in 1 second (FEV1) mean difference (MD) for FDC was 0.01 (95% CI, – 0.01 to 0.03); St George’s respiratory COPD specific questionnaire (SGRQ) MD for FDC was – 0.76 (95% CI, – 1.81 to 0.29); transitional dyspnea index (TDI) MD for FDC was 0.33 (95% CI, 0.06 to 0.60) compared to that of ACL. Furthermore, trough FEV1 MD for FDC was 0.05 (95% CI, 0.03 to 0.06); SGRQ MD for FDC was – 1.52 (95% CI, – 2.57 to-0.47); TDI MD for FDC was 0.43 (95% CI, 0.15 to 0.70) compared to that of the FOR. The evidence for each result was accurate and the results were unaffected by the duration of the study.
CONCLUSION: The findings of this study showed that, unlike monotherapies, FDC significantly improves lung function, dyspnea, and quality of life. In addition, FDC significantly improves dyspnea compared to ACL alone.
PMID:34731694 | DOI:10.1016/j.hrtlng.2021.07.005
