Research Explores Patterns of Triple Therapy Use in Patients With Inadequately Controlled COPD

A cross-sectional, observational study found that triple therapy was initiated in patients with chronic obstructive pulmonary disease (COPD) who experienced poor disease control on maintenance therapy.

A study published in the International Journal of Chronic Obstructive Pulmonary Disease found that first-time triple therapy was used most often in patients with chronic obstructive pulmonary disease (COPD) that was controlled inadequately through maintenance therapy.

The researchers used data from the UK Clinical Practice Research Datalink for this study, which is a database of anonymized, longitudinal medical records of patients who go to a contributing primary care practice in the United Kingdom. The objective of the study was to determine the sociodemographic and clinical characteristics of patients with COPD who initiated fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) as single-inhaler triple therapy.

Patients were eligible for the study if they were 35 years or older and were diagnosed with COPD. Patients also had to have initiated triple therapy for the first time between November 2017 and November 2018. Eligible participants had a recorded forced vital capacity (FEV1) and at least 12 months of medical history prior to index date. Patients who had a medical condition that was incompatible with a diagnosis of COPD at any point in their medical history were excluded.

There were 3536 patients who initiated FF/UMEC/VI for the first time who were included in the study as 1 cohort, with 610 (17.3%) who had not received multi-inhaler triple therapy (MITT) before. A second cohort of 6540 patients contained 702 new users of beclomethasone/formoterol/glycopyrronium bromide (BEC/FOR/GLY) and 5228 new users of MITT.

The mean age of the FF/UMEC/VI users was 70.9 years and 1908 (54%) were male. An asthma diagnosis was found in 25% of the patients.

In patients with FEV1 and Medical Research Council (MRC) data, 65% had an MRC dyspnea score of at least 3 and 44% had a FEV1% predicted at less than 50%. Patients with a history of MITT had similar proportions, with 67% who had a MRC dyspnea score of at least 3 and 46% who had a FEV1% predicted of less than 50%.

Patients also experienced exacerbations of COPD prior to triple therapy initiation, with 64% of patients experiencing 1 or more moderate or severe exacerbations, 20% experiencing 1 or more severe exacerbations, and 6% experiencing 1 or more severe exacerbations without a moderate exacerbation. Moderate exacerbations were experienced by 59% of the patients. A similar pattern of exacerbations was found in patients who had a previous history of MITT.

There were 1623 patients (46%) who had received MITT in the year prior to FF/UMEC/VI initiation, 897 patients who received inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy, and 417 patients who received long-acting muscarinic antagonist (LAMA)/LABA therapy.

The mean age of the 6450 patients who were new to triple therapy was 68.6 years and 53% were male. There were 2073 patients (32%) who had a current diagnosis of asthma.

A higher proportion of new users of FF/UMEC/VI had clinically significant breathlessness compared with new users of MITT (51% vs 46%). Patients on BEC/FOR/GLY had the highest proportion of MRC scores of 3 or higher (56%). Patients on FF/UMEC/VI more commonly had a FEV1 predicted less than 50% compared with MITT users (38% vs 32%).

There were a total of 3377 patients (52%) who had experienced 1 or more moderate or severe exacerbations of COPD. LAMA/LABA therapy was the most common maintenance therapy used prior to triple therapy initiation in patients who started FF/UMEC/VI (34%) when compared with patients starting MITT (14%) or BEC/FOR/GLY (25%). There were 260 patients (4%) who had received no maintenance therapy before triple therapy initiation.

There were some limitations to this study. The possibility of misdiagnosing COPD as asthma and vice versa is a variable to consider. Patients with an asthma diagnosis along with a COPD diagnosis were not excluded from this study. The definition of triple therapy may have led to a misclassification of medication. Patients may have been classified as MITT users if switching between non-MITT regimens. Variables for describing MRC and FEV1 were missing for 7% and 15% of the patients, respectively. Finally, summary data could be skewed if the values for missing patients differ from the nonmissing data.

The researchers concluded that first-time triple therapy was initiated in patients with COPD that was uncontrolled on maintenance therapy in a primary care setting. Characteristics were also similar in patients with and without comorbid asthma, with the exception of FEV1% predicted.

Reference

Rothnie KJ, Joksaite S, Sansbury LB, Compton C, Di Boscio V, Ismaila AS. Characteristics of new users of single- and multiple-inhaler triple therapy for COPD in primary care in England. Int J Chron Obstruct Pulmon Dis. 2022;17:1455-1466. doi:10.2147/COPD.s338436