Rationale: The prospective, non-interventional DACCORD study is collecting data over 2 years from a cohort of COPD patients recruited in primary and secondary care across Germany who either initiated or changed COPD maintenance medication prior to entry. Following the approval of LABA/LAMA fixeddose combinations (FDCs) in 2013, DACCORD was broadened to also follow a cohort of patients receiving a regimen containing any LABA/LAMA FDC. Here, we report 1-year follow-up data of a subgroup of patients of this 2nd cohort who discontinued ICS-containing therapy at study entry and initiated a LABA/LAMA-FDC based therapy instead.
Methods: Baseline demographics were collected and COPD severity determined (GOLD 2011). The number of exacerbations was collected over 6 months prior to study entry and every 3 months during the course of the study. Current COPD medication was recorded at each visit. Health status was assessed at baseline and after one year using the COPD Assessment Test (CAT).
Results Of 4227 patients in the 2nd cohort with 1-year data, 766 discontinued ICS and initiated LABA/LAMA FDC on entry to DACCORD (58% male, mean age 67.2 years, baseline mean FEV., 63.4% predicted). In this subgroup, prior to study entry 58% of patients were receiving LABA+ICS, 31% LABA+LAMA+ICS, 4.7% ICS Monotherapy, 4.3% a Theophylline and/or PDE4-containing regimen in addition to ICS, 2.0% LAMA+ICS. In the 6 months prior to study entry, 27.9% reported at least one exacerbation.
Despite ICS discontinuation, only 19.5% patients exacerbated during the 1-year follow-up (annualized exacerbation rate 0.28 events/patient/year- compared to 0.30 of the total population). Exacerbations were evenly spread across the one year observational period (6.5%, 5.2%, 7.0% and 7.2% in the first, second, third and fourth quarters, respectively). At baseline, 43.9% of patients were GOLD Category B, compared with 60.8% at year 1, with the percentage in GOLD Category D decreasing from 46.3% at baseline to 24.7% at year 1. The mean CAT total score improved from 20.0 at baseline to 17.2 at year 1.
Conclusions: Several recent interventional studies have analyzed the effect of ICS withdrawal in COPD. Here, we extend these findings into a real-life cohort, to show that ICS withdrawal followed by initiation of a LABA/LAMA FDC did not lead to an increase in exacerbations in the following year and was associated with an improvement in health status.