Purpose: This study aimed to evaluate the non-inferiority of initiating extrafine
beclometasone dipropionate/formoterol fumarate (BDP/FF) versus double bronchodilation (long-acting beta-agonists [LABA]/long-acting muscarinic antagonists [LAMA]) among patients with a history of COPD exacerbations.
Patients and methods: A historical cohort study was conducted using data from
the UK’s Optimum Patient Care Research Database. Patients with COPD ⩾40
years at diagnosis were included if they initiated extrafine BDP/FF or any LABA/LAMA double therapy as a step-up from no maintenance therapy or
monotherapy with inhaled corticosteroids (ICS), LAMA, or LABA and a history of
≥2 moderate/severe exacerbations in the previous two years. The primary
outcome was exacerbation rate from therapy initiation until a relevant therapy
change or end of follow-up. Secondary outcomes included rate of acute respiratory events, acute oral corticosteroids (OCS) courses, and antibiotic
prescriptions with lower respiratory indication, modified Medical Research
Council score (mMRC) ≥2, and time to first pneumonia diagnosis. The non59 inferiority boundary was set at a relative difference of 15% on the ratio scale.
Five potential treatment effect modifiers were investigated.
Results: A total of 1,735 patients initiated extrafine BDP/FF and 2,450 patients
initiated LABA/LAMA. The mean age was 70 years, 51% were male, 41% current
smokers, and 85% had FEV1 <80% predicted. Extrafine BDP/FF showed non64 inferiority to LABA/LAMA for rate of exacerbations (incidence rate ratio [IRR] =
65 1.01 [95%CI 0.94-1.09]), acute respiratory events (IRR = 0.98 [0.92-1.04]), acute 20 OCS courses (IRR = 1.01 [0.91-1.11]), and antibiotic prescriptions (IRR = 0.99 67 [0.90-1.09]), but not for mMRC (OR = 0.93 [0.69-1.27]) or risk of pneumonia (HR= 0.50 [0.14-1.73]). None of the a priori defined effect modifier candidates affected the comparative effectiveness.
Conclusions: This study found that stepping up to extrafine BDP/FF from no
maintenance or monotherapy was not inferior to stepping up to double
bronchodilation therapy in patients with history of exacerbations.
- electronic health records
- comparative effectiveness
- chronic obstructive pulmonary disease
- Comparative effectiveness
- Chronic obstructive pulmonary disease
- Electronic health records