Efficacy and Safety of Dual Bronchodilator Therapy for COPD – From Randomized Clinical Trials to Real-World Clinical Practice

Introduction

The main goals of COPD therapy include alleviating disease symptoms, improving quality of life, and reducing the risk of future exacerbations. According to the current recommendations of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), the cornerstone of pharmacotherapy consists of bronchodilators – long-acting muscarinic antagonists (LAMA) and long-acting β₂-agonists (LABA), either as monotherapy or in combination therapy.

Dual bronchodilator therapy is recommended as initial therapy for COPD patients in group B with dyspnea and group D with high symptom activity. For other groups, it is indicated in cases of inadequate response to other therapy options, such as monotherapy with either a LAMA or LABA agent.

The aim of the systematic review was to analyze the efficacy and safety of dual bronchodilator therapy for COPD compared to other approaches based on data from randomized controlled clinical trials (RCTs) and real-world practice studies.

Analyzed Studies

The authors searched the PubMed database for studies published until April 4, 2019. Inclusion criteria encompassed phase II/III/IV RCTs lasting ≥ 24 weeks and studies conducted in real-world clinical practice conditions, which compared dual LAMA + LABA therapy with monotherapy of either agent, another dual therapy (LABA + LAMA), LABA + inhaled corticosteroid (ICS) therapy, or triple combination therapy (LABA + LAMA + ICS).

A total of 24 RCTs and 8 real-world clinical practice studies were included. The duration of the RCTs ranged from 24 to 64 weeks. The risk of bias was low in most studies.

Findings

In patients receiving dual LAMA + LABA therapy, improvements in lung function, quality of life, and reductions in the incidence of exacerbations and dyspnea were observed compared to monotherapy, LABA + ICS combination, and triple combination therapy (LAMA + LABA + ICS), both in RCTs and real-world clinical practice studies.

Dual LAMA + LABA therapy was well tolerated by patients and demonstrated a safety profile similar to that of monotherapies with individual agents. Patients on LAMA + LABA therapy had a lower incidence of pneumonia compared to regimens including ICS.

Conclusion

The analysis results indicated that dual LAMA + LABA therapy improves lung function, quality of life, and reduces the risk of exacerbations compared to other pharmacotherapy options for COPD. The study findings were highly consistent, thereby strengthening the position of dual bronchodilator therapy in the management of COPD.

(holi)

Source: Anzueto A., Kaplan A. Dual bronchodilators in chronic obstructive pulmonary disease: evidence from randomized controlled trials and real-world studies. Respiratory Medicine: X 2020; 2: 100016, doi: 10.1016/j.yrmex.2020.100016.