gms | German Medical Science

Background: Long-acting bronchodilators (LABA/LAMA) are the cornerstone of pharmacotherapy in COPD, and current guidelines recommend their use as first-line therapy in symptomatic COPD patients. Given the course of COPD, patients are likely to switch drugs in daily practice.

Research question and objective: Our aim is to describe initial management of newly diagnosed COPD patients with different stages of airflow limitation in a real-world setting.

Methods: German claims data covering the period 04/2014–03/2019 were analyzed. Continuously insured persons ≥40 years old with at least two outpatient specialists’ diagnoses and/or one inpatient diagnosis of COPD (ICD-10: J44), and no concomitant asthma diagnosis were included. Patients without COPD diagnoses in the pre-index period of at least 12 months were considered as incident cases.

Patients with known FEV1 value at the time of incident diagnosis, as derived by the documented ICD-10 subcode, served as analysis sample. Patient characteristics and therapies (outpatient prescriptions) were reported for four pre-defined FEV1 categories (<35%, 35<50%, 50<70%, ≥70% predicted). The percentage of patients with at least one change in treatment within the first year after diagnosis was compared between groups.

Results: Of 17,464 incident COPD patients 7,426 had known FEV1 values. Thereof, 1,171 patients (15.8%) were classified with FEV1<35%, 1,490 (20.1%) with 35<50%, 2,813 (37.9%) with 50<70%, and 1,952 (26.3%) with ≥70%. Age and comorbidity level did not differ between groups (mean age: 69.2–70.1 years; mean Charlson Comorbidity Index 5.0–5.2). More female patients were found in the group with FEV1≥70% (44.1%) compared with the other groups (34.4%–36.7%).

The proportion of patients who started a long-term treatment within the first year after diagnosis was 41.9% in the group with FEV1≥70%, 65.3% in FEV1 50<70%, 69.3% in FEV1 35–50%, and 63.7% in FEV1<35%. In patients with FEV1<70%, the most frequent first-line therapy was LABA+LAMA and most treated patients with a baseline FEV1≥70% initially received LAMA monotherapy (34.5%).

Of all patients who started treatment in the first year, 15.1% switched to another regime in the same period (16.8%/15.2%/15.1%/12.0% in FEV1<35%/FEV1 35<50%/FEV1 50<70%/FEV1≥70%). Among patients with an FEV1<35% at baseline, the most frequently observed treatment adjustment was the addition of LABA in patients receiving LAMA monotherapy (15.2%).

Discussion: Observed treatment strategies differed between COPD patients with different levels of airflow limitation. However, we identified a substantial proportion of patients not receiving any long-term treatment, even in the groups with severe airflow limitation.

Implication: Severe airflow limitation at the time of diagnosis is an indicator for early use of combination therapies such as LABA+LAMA in patients with newly diagnosed COPD. This study demonstrated adherence to guidelines in current clinical practice. However, as one in three patients with severe airflow limitation remains untreated, there is a high need to need to tackle under-treatment.