The “Patients, Intervention, Control, and Outcome” (PICO) framework was utilized to improve the relevance of the search results, as previously described. We used the following search terms in the PubMed, MEDLINE (OvidSP), EMBASE and Cochrane Library databases to identify studies published up to May 15, 2021: “chronic obstructive pulmonary disease”, “triple”, “long-acting antimuscarinics”, “long-acting beta-2 agonists” or “inhaled corticosteroids”. This study was prospectively registered in Prospero (CRD42020186726). ![]() This meta-analysis followed the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. We therefore performed this systematic review to determine the effect of ICS/LABA/LAMA compared with LABA/LAMA or ICS/LABA using a single device on the risk of mortality and exacerbation and on other relevant outcomes in patients with COPD. Single-inhaler therapy has been shown to improve lung function and health status, but evidence of a reduction in mortality with single-inhaler triple therapy versus single-inhaler dual therapy has not been well documented in previous meta-analyses. In some RCTs comparing triple therapy with dual therapy in COPD, there might be a bias resulting from the use of multiple inhaler devices. Single-inhaler triple therapy may be of benefit in patients with COPD by decreasing inhaler errors, improving adherence rates, and decreasing healthcare costs. The Global Initiative for Obstructive Lung Disease (GOLD) management strategy recommends using ICS/LABA + LAMA in patients with persistent breathlessness, exercise limitation or persistent exacerbation, but it does not specify when to use single-inhaler triple therapy. The regular administration of inhaled drugs, including long-acting beta2-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICSs), is widely acknowledged as a major component of the treatment of COPD. Trial registration PROSPERO #CRD42020186726.Ĭhronic obstructive pulmonary disease (COPD) is a worldwide public health challenge with a high prevalence and high morbidity and mortality rates. However, the risk of pneumonia is higher with ICS/LAMA/LABA FDC than with LABA/LAMA FDC. This meta-analysis suggests that single-inhaler triple therapy is effective in reducing the risk of death of any cause and of moderate or severe exacerbation in COPD patients. The risk of pneumonia was, however, significantly higher with ICS/LAMA/LABA FDC than with LABA/LAMA FDC (risk ratio, 1.55 95% CI 1.35–1.80). The FEV1 increased significantly more under single-inhaler triple therapy than under ICS/LABA FDC (mean difference, 103.4 ml 95% CI 64.65‐142.15). Single-inhaler triple therapy reduced the risk of exacerbation and prolonged the time to first exacerbation compared with single-inhaler dual therapy. This meta-analysis indicated that single-inhaler triple therapy resulted in a significantly lower rate of all-cause mortality than LABA/LAMA FDC (risk ratio, 0.70 95% CI 0.56‐0.88). ResultsĪ total of 25,171 patients suffering from COPD were recruited for the 6 studies. ![]() The Cochrane Collaboration tool was used to assess the quality of each randomized trial and the risk of bias. The primary end points were the effect of single-inhaler triple therapy compared with single-inhaler dual therapy on all-cause mortality, the risk of acute exacerbation of COPD (AECOPD), and some safety endpoints. We searched the PubMed, MEDLINE (OvidSP), EMBASE and Cochrane Library databases to investigate the effect of single-inhaler triple therapy in COPD. We systematically reviewed randomized controlled trials (RCTs) of single-inhaler triple therapy in patients with COPD. LABA/LAMA or ICS/LABA using a single device. This meta-analysis included only RCTs that compared ICS/LABA/LAMA vs.
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