Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD.

Abstract

In Italy, long-acting bronchodilator (LABA/LAMA) fixed-dose combinations are widely used for treating chronic obstructive pulmonary disease (COPD). These medications are available in various inhaler devices, but clinical guidelines do not recommend a specific device, leaving the choice to clinicians based on patient needs. To date, no studies have directly compared the effectiveness and safety of different LABA/LAMA devices. This retrospective observational study evaluated the utilization, effectiveness, and safety of LABA/LAMA inhaler devices in COPD patients in the Lazio region, representing about 10% of Italy's population. Patients aged 45 and older who initiated LABA/LAMA treatment between January 2017 and December 2019 were included. The devices analyzed were dry powder inhalers (DPI) capsule/strip (DPI-t, reference group), DPI with a reservoir (DPI-r), and soft mist inhalers (SMI). The study identified 12,346 eligible patients, with over 80% having prior COPD drug use. Of these, 53.2% used DPI-t, 19.7% DPI-r, and 27.1% SMI. No significant differences in severe exacerbations, mortality, pneumonia, or cerebro-cardiovascular events were observed among the devices. Hazard ratios for key outcomes (e.g., severe exacerbations, mortality) showed overlapping confidence intervals across device types, suggesting no device offered superior effectiveness or safety. This is the first study to assess LABA/LAMA device use in real-world clinical practice for COPD. Findings suggest therapeutic equivalence among devices, supporting flexibility in prescribing. Further research is needed to inform cost-effective prescribing policies for LABA/LAMA therapies.