Rationale Inhaled corticosteroid (ICS) plus long-acting β2-agonist (LABA) therapy is indicated for different patient groups with chronic obstructive pulmonary disease (COPD) in the USA and Europe. In the previous version of the Global initiative for chronic Obstructive Lung Disease (GOLD) recommendations, the use of ICS plus LABA therapy was restricted to patients with severe and very severe lung-function impairment and frequent exacerbations, with overtreatment in milder patient populations well documented. The current GOLD document recommends the use of ICS plus LABA maintenance therapy for patients in categories C and D.
Methods We present post hoc analyses from the two pivotal 1-year TONADO studies to assess the use of ICS plus LABA maintenance therapy in patients classified as GOLD A/B and C/D. As these studies were initiated before the update of the GOLD recommendations, no modified Medical Research Council Dyspnoea scale or COPD Assessment Test data were available to further classify these patients into categories A or B and C or D. Based on the reported COPD exacerbation history and lung-function measurements, 2259 patients were classified as GOLD A/B and 2903 as GOLD C/D. Baseline characteristics and concomitant medications at baseline are presented in Table 1.
Results In the GOLD A/B subgroup, 7.3% of patients were receiving treatment with ICS alone and 31.3% were receiving treatment with ICS plus LABA at study baseline. In the GOLD C/D subgroup, the incidences of patients receiving treatment with ICS alone and ICS plus LABA at study baseline were 8.8% and 45.5%, respectively.
Conclusions Almost 40% of patients classified as GOLD A/B are receiving treatment with ICS maintenance therapy, either alone, in free combination or as a fixed-dose combination therapy, despite GOLD recommendations for use only in patients with more severe lung-function impairment and frequent exacerbations. Our analyses confirm previous reports, highlighting that treatment regimens containing ICS therapy are being used early in the management of patients with COPD, which may not be appropriate based on current GOLD recommendations.
Funding Boehringer Ingelheim.
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