Abstract Rationale Patients with COPD on maintenance triple therapy (TT) may continue to experience exacerbations, high symptom burden and accelerated lung function decline. This study compared the characteristics and outcomes of patients with a history of frequent acute exacerbations of COPD (AECOPD) while on TT with other COPD patients from the NOVELTY cohort (NCT02760329). Methods Patients with a physician-assigned COPD diagnosis were classified at baseline as (a) frequent AECOPD while on TT (≥2 moderate or ≥ 1 severe exacerbations in past 12 months); (b) all other COPD patients regardless of baseline exacerbation or treatment; (c) infrequent AECOPD on TT (subset of b with ≤1 moderate exacerbation in past 12 months). Negative binomial models, Cox proportional hazards and generalized linear mixed regression models, adjusted for baseline characteristics, evaluated exacerbations, mortality, changes in forced expiratory volume in one second (FEV1) and Chronic Airways Assessment Test (CAAT) scores from baseline to year 3. Results Patients with frequent AECOPD on TT at baseline (n = 484), compared with all other COPD patients (n = 4190) and those with infrequent AECOPD on TT at baseline (n = 1276), had a similar mean age (67 vs 66 and 68 years) and sex distribution (female: 42% vs 41% and 38%). However, they demonstrated worse airflow obstruction (mean post-bronchodilator FEV1 % predicted: 49% vs 64% and 55%), more severe dyspnea (modified Medical Research Council Dyspnea Scale grade ≥2: 70% vs 49% and 58%), reduced health-related quality of life (HRQoL) (mean CAAT score: 21.0 vs. 16.9 and 18.1) and more cardiovascular comorbidity (30% vs 23% and 24%). During follow-up, patients with frequent AECOPD on TT at baseline experienced ∼3-fold higher moderate or severe exacerbation rates (p 0.01) and a 65–69% higher mortality rate (p 0.01) versus comparator cohorts (Figure). These associations were similar in current and former smokers. Patients with frequent AECOPD on TT at baseline maintained poor CAAT scores (20.5 at year 3 vs 21.0 at baseline) and low post-bronchodilator FEV1 % predicted (50% at year 3 vs 49% at baseline). Sensitivity analyses across two groups (patients without a baseline concomitant asthma diagnosis and those with FEV1/FVC 0.7 at any year of the study) showed similar results. Conclusions Patients with frequent AECOPD on TT represent an identifiable high-risk subgroup with substantially higher disease burden and mortality, persistently worse airflow limitation and HRQoL than other patients with COPD. These findings underscore the urgent need for proactive identification and optimization of treatment for these patients. This abstract is funded by: AstraZeneca
Pollack et al. (Fri,) studied this question.