Factors influencing LAMA addition to COPD patients receiving ICS/LABA in clinical practice-RETRIEVE study

Background:Limited real-world data are available for triple therapy initiation in ChronicObstructivePulmonaryDisease(COPD)patients. Aims:Evaluation of lung function and incidence of exacerbations associated with the use of FixedDoseCombination(FDC) of fluticasone/salmeterol(ICS/LABA)compared to ICS/LABA plus anticholinergic(LAMA)in COPD patients in a“real-world”setting. Methods:Retrospective study evaluating 466 medical records from COPD patients between 2012-2018 who were allocated in 2 groups:A=224(ICS/LABA), B=242(B₀period:ICS/LABA≥1 year, B₁period:ICS/LABA+LAMA). Results:A significant difference was observed in the mean age between A, B(70.8±10.3,72.5±8.5 respectively, p=.038).Heart failure and osteoporosis were frequently observed in B(p=.024)than in A(p=.003). Forced expiratory volume in 1 second % predicted, FEV₁%pred.(±SD)assessed in 2 groups at the day of ICS/LABA initiation, was significantly lower inB₀(52.1±14.6)than A₀(60.5±15.0)(p<.001) for the treatment period of 32.1±21.6months vs.Β₀(20.6±11.6months). In B, the slope over time of FEV₁%pred.differs significantly between B₀-B₁(p=.008)increasing after LAMA initiation. The AnnualIncidenceRate(AIR)of A₀ for total_(T), moderate_(M) and severe_(S)COPD exacerbations was [3.21_T, 2.15_M,1.06_S] and was significantly higher than B₁[1.12_T, 0.92_M, 0.19_S].The AIR of B₁ was significantly lower than B₀[3.24_T, 1.86_M, 1.38_S](p<.001). Conclusions:In our retrospective analysis the decision to initiate triple therapy was based on age, comorbidities, anticipated patient benefit and increased risk of exacerbations. Overall, both the dual and triple therapy for COPD resulted in reduction of exacerbations and improvement of lung function parameters.