First, important questions in clinical practice remain over the role of triple therapy, which include the magnitude of clinical benefit and the identification of patients with the best risk-benefit profile for treatment. A systematic and critical review of the evidence base for single-inhaler triple therapy is warranted to support clinical decision making for the following reasons. Recently, two single-inhaler triple therapies have received marketing authorisation from the European Medicines Agency and one other is in late-stage clinical development. However, evidence suggests that triple therapy is often over prescribed in clinical practice and used in patients who are not frequent exacerbators. Triple therapy, provided as multiple inhalers, has in pooled analyses been shown to improve lung function, health-related quality of life and exacerbations. Evidence suggests that dual therapy with LABA and inhaled corticosteroids (ICS) and the step up to triple therapy (LAMA/LABA/ICS) be considered for a select group of patients who continue to exacerbate despite appropriate treatment and/or features suggesting steroid responsiveness. In those patients with a high risk of exacerbations, therapy relies on a long-acting muscarinic antagonist (LAMA) or if a patient is highly symptomatic, dual therapy with a LAMA and a long-acting β 2 agonist (LABA). The 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document, based on the best-available evidence from the published literature, recommend that choice of treatment depends on symptom and exacerbation severity. Pharmacological treatment relies predominately on inhaled bronchodilators and anti-inflammatory agents. Trial registrationĬhronic obstructive pulmonary disease (COPD) is a leading cause of mortality and morbidity worldwide. Future research on specific patient phenotype thresholds that can support treatment and funding decisions is now required from well-designed, robust, clinical trials. The decision to prescribe triple therapy should consider patient phenotype, magnitude of benefit and increased risk of adverse events. There were important differences in study designs and populations impacting the interpretation of the results and indicating there would be significant heterogeneity in cross-trial comparisons. In the largest study, there was a significantly higher incidence of pneumonia in the triple therapy arm. The absolute benefit appeared to be greater in patients with higher eosinophil counts or historical frequency of exacerbations and ex-smokers. The patient-based number needed to treat for the moderate or severe exacerbation outcome ranged between approximately 25–50 (preventing one patient from having an event) and the event-based number needed to treat of around 3–11 (preventing one event). Triple therapy resulted in the reduction of the annual rate of moderate or severe exacerbations in the range of 15–52% compared with LAMA/LABA, 15–35% compared to LABA/ICS and 20% compared to LAMA. We identified 523 records, of which 15 reports/abstracts from six RCTs were included. The primary outcome was the annual rate of moderate and severe exacerbations. We conducted a systematic search, from inception to December 2018, of randomised controlled trials (RCTs) of single-inhaler triple therapy in patients with COPD. We also evaluated and compared study designs and population characteristics to assess the strength of the evidence base. We compared the efficacy and safety of single-inhaler triple therapy to assess the magnitude of benefit and to identify patients with the best risk-benefit profile for treatment. A number of single-inhaler triple therapies are now available and important clinical questions remain over their role in the patient pathway. triple therapy, is reserved for a select group of symptomatic patients with chronic obstructive pulmonary disease (COPD) who continue to exacerbate despite treatment with dual therapy (LABA/LAMA). Guidelines recommend that treatment with a long-acting β 2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), and inhaled corticosteroids (ICS), i.e.
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