Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD
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...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-05-01
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| Series: | COPD |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/15412555.2025.2506548 |
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| author | Sara Lopes Maria Lucia Marino Filomena Fortinguerra Nera Agabiti Valeria Belleudi Francesco Trotta |
| author_facet | Sara Lopes Maria Lucia Marino Filomena Fortinguerra Nera Agabiti Valeria Belleudi Francesco Trotta |
| author_sort | Sara Lopes |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-cd98015a4a754746868f41ebfb3c40d5 |
| institution | Kabale University |
| issn | 1541-2555 1541-2563 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | COPD |
| spelling | doaj-art-cd98015a4a754746868f41ebfb3c40d52025-08-20T03:48:24ZengTaylor & Francis GroupCOPD1541-25551541-25632025-05-0122110.1080/15412555.2025.2506548Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPDSara Lopes0Maria Lucia Marino1Filomena Fortinguerra2Nera Agabiti3Valeria Belleudi4Francesco Trotta5Department of Epidemiology, Lazio Regional Health Service, Rome, ItalyItalian Medicines Agency, Rome, ItalyItalian Medicines Agency, Rome, ItalyDepartment of Epidemiology, Lazio Regional Health Service, Rome, ItalyDepartment of Epidemiology, Lazio Regional Health Service, Rome, ItalyItalian Medicines Agency, Rome, ItalyIn 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.https://www.tandfonline.com/doi/10.1080/15412555.2025.2506548Chronic obstructive pulmonary diseaseLABA/LAMAinhaler deviceuseeffectivenesssafety |
| spellingShingle | Sara Lopes Maria Lucia Marino Filomena Fortinguerra Nera Agabiti Valeria Belleudi Francesco Trotta Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD COPD Chronic obstructive pulmonary disease LABA/LAMA inhaler device use effectiveness safety |
| title | Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD |
| title_full | Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD |
| title_fullStr | Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD |
| title_full_unstemmed | Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD |
| title_short | Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD |
| title_sort | use effectiveness and safety of inhaler devices for laba lama fixed dose combinations in patients with copd |
| topic | Chronic obstructive pulmonary disease LABA/LAMA inhaler device use effectiveness safety |
| url | https://www.tandfonline.com/doi/10.1080/15412555.2025.2506548 |
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