Abstract
There are more single inhaler device triple therapy available for COPD patients now. However, the effect of long-term triple therapy fixed dose combination (FDC) on mortality remains unclear. This study aimed to evaluate the impact of one-year single inhaler device triple therapy, including long-acting β2-agonists (LABAs), long-acting muscarinic receptor antagonists (LAMAs), and inhaled corticosteroids (ICSs), with dual therapies, comprised of either LABA/LAMA or ICS/LABA, on the mortality of patients with COPD. We searched the PubMed, Cochrane library, Web of Science, Embase databases, and clinical trial registry of clinicaltrials.gov and WHO ICTRP. Randomized controlled trials (RCTs) compared single inhaler device triple and dual therapies for 52 weeks were selected for the meta-analysis. The primary endpoint was all-cause mortality. A total of 6 RCTs were selected for the meta-analysis, including 10,274 patients who received single inhaler device triple therapy (ICS/LABA/LAMA FDC) and 12,395 patients who received ICS/LABA or LABA/LAMA dual therapy. Risk of death was significantly lower in the ICS/LABA/LAMA FDC group compared to the LABA/LAMA group (RR = 0.69, 95% CI = 0.53–0.90, p = 0.007). There was no significant difference in mortality between the ICS/LABA/LAMA FDC and ICS/LABA therapy groups (RR = 0.94, 95% CI = 0.72–1.24, p = 0.66). In addition, patients receiving ICS/LABA/LAMA FDC therapy had less moderate or severe exacerbations compared with the dual therapy groups (RR = 0.76, 95% CI = 0.73–0.80, p < 0.001 for LABA/LAMA; RR = 0.84, 95% CI = 0.78–0.90, p < 0.001 for ICS/LABA). By contrast, the risk of pneumonia in the ICS/LABA/LAMA FDC group was higher than in the LABA/LAMA group (RR = 1.43, 95% CI = 1.21–1.68, p < 0.001). In conclusion, ICS/LABA/LAMA FDC therapy could help improve the clinical outcomes of patients with COPD. However, triple therapy could increase the risk of pneumonia in comparison with LABA/LAMA dual therapy.
Highlights
The prevalence of chronic obstructive pulmonary disease (COPD) remains high and can be associated with high morbidity and mortality rates, so this clinical entity remains a major public health issue
There was no significant difference regarding the risk of adverse events, serious adverse events, cardiovascular events and respiratory tract infections between triple therapy and dual therapy (LABA/long-acting muscarinic receptor antagonists (LAMAs) or inhaled corticosteroids (ICSs)/LABA), we found that ICS/LABA/LAMA fixed dose combination (FDC) therapy had significantly higher risk of pneumonia compared with LABA/LAMA therapy (RR = 1.42, 95% CI = 1.21–1.66, p < 0.001) in the pooled analysis of 3 Randomized controlled trials (RCTs), [20,21,24] in which BUD, fluticasone furoate (FF), and beclomethasone dipropionate (BDP) were used as the ICS, one in each study
The number of enrolled RCTs was limited in this meta-analysis, because each had unique treatment arm comparisons. All these factors may affect the heterogeneity of the meta-analysis. This meta-analysis indicated that COPD patients with ICS/LABA/LAMA FDC single inhaler device triple therapy could reduce 31% mortality rate compared to those with
Summary
The prevalence of chronic obstructive pulmonary disease (COPD) remains high and can be associated with high morbidity and mortality rates, so this clinical entity remains a major public health issue. [4,5,6,7] Before the development of a single inhaler device containing ICS, LABA and LAMA, open triple therapy, such as ICS plus LABA/LAMA or ICS/LABA plus LAMA was the most common prescription for patients who required triple therapy. These patients needed at least two inhalers for use more than once daily, and these inhalers were used in different ways. There have been issues reported that were potentially associated with the high risk of incorrect use and poor compliance [8,9,10,11]
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