Background: Several large randomized clinical trials (RCTs) have assessed the efficacy and safety of inhaled corticosteroid (ICS) combination regimens versus non-ICS therapy in patients with chronic obstructive pulmonary disease (COPD) at increased risk of exacerbation risk with mixed results.
Methods: We performed a systematic literature review and meta-analysis of RCTs comparing the effect of ICS-containing combination therapy and non-ICS regimen in patients with COPD.
Results: A total of 54 RCTs (N = 57,333) reported treatment effects on various outcomes and were eligible for inclusion. Overall, the number of patients experiencing moderate/severe exacerbations was significantly lower for ICS-containing combination therapy versus non-ICS therapy (RR: 0.86 [95% CI: 0.80– 0.93]). The annual rate of exacerbations was also significantly reduced by 22% (0.78 [0.72– 0.86]) with ICS-containing versus non-ICS therapy. The annual rate of exacerbations requiring hospitalisation was reduced by 31% versus non-ICS therapy (0.69 [0.54– 0.88]); similar reduction was observed for exacerbations requiring oral steroids (0.69 [0.66– 0.73]). Overall, the effect on trough FEV1 was comparable between ICS-containing and non-ICS therapies (follow-up: 6– 52 weeks); however, a significant improvement in lung function (trough FEV1) was observed for ICS/LABA versus LABA (MD: +0.04 L [0.03− 0.05]) and ICS/LABA/LAMA versus LAMA (MD: +0.09 L [0.05− 0.13]) regimens. In addition, a significant improvement in QoL was observed with ICS-containing versus non-ICS therapy (MD in SGRQ score: − 0.90 [− 1.50, − 0.31]).
Conclusion: This meta-analysis demonstrated that a wide range of patients with COPD could benefit from dual and triple ICS-containing therapy.
Keywords: meta-analysis, chronic obstructive pulmonary disease, inhaled corticosteroid, dual therapy, triple therapy, exacerbation