Exacerbations in COPD patients treated with Inhaled Corticosteroids/Long-acting β₂ agonists combinations, switching to another combination drugs or inhaler device: A “real – world” study

Abstract

This study investigates the effects of switching to different devices of the same active substance or between different active substances, in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with Inhaled Corticosteroids (ICS) plus Long-acting β₂-adrenergic agonists (LABAs) in terms of incidence of exacerbations. A retrospective cohort analysis, based on administrative databases of 3 Italian Local Health Units, was conducted. Patients with at least one prescription of a fixed dose combination of ICS/LABA from 1 January 2009 to 31 December 2011 were included. The index-date was defined as the earliest date within the inclusion period in which the patient had the first switch of drug or device (switchers) or the first prescription of ICS/LABA for patients continuing with the same treatment (non-switchers). Patients were observed until 31 December 2012. Propensity score matching was performed to check for cofounding effects. COPD exacerbations were defined as COPD-related hospitalization and prescription of corticosteroids and antibiotics. Number of: hospitalizations for COPD, oral corticosteroids and antibiotics prescriptions were analyzed using Poisson regression models. After matching, 1,759 patients per arm were analyzed. No statistically significant difference was found between study groups’. Incidence Rate Ratio in favor of non-switcher patients, as compared to switcher patients, was 1.41 (95% CI: 1.10–1.80) for number of hospitalizations, 1.05 (95% CI: 1.11–1.09) and 1.02 (95% CI: 0.96–1.09) for number of oral corticosteroids and antibiotics prescriptions, respectively. Our findings showed that switching to different devices of the same active substance or among different active substances in COPD patients treated with a fixed dose combination of ICS/LABA can lead to an higher likelihood of exacerbation COPD related rates than those who did not switch. Considering the study’s limitations, further studies are needed in order to confirm and enhance the generalizability of our findings.

Keywords:

• chronic obstructive pulmonary disease
• exacerbations
• inhaled corticosteroids
• long-acting β₂-agonist
• switching therapy

Public Interest Statement

This real-world study investigates the effects of switching to different devices of the same active substance or between different active substances, in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with Inhaled Corticosteroids (ICS) plus Long-acting β₂-adrenergic agonists (LABAs) in terms of exacerbations. A retrospective cohort analysis, based on administrative databases of 3 Italian Local Health Units, was performed. COPD exacerbations were defined as COPD-related hospitalization and prescription of corticosteroids and antibiotics. Our findings showed that switching to different devices of the same active substance or among different active substances in COPD patients treated with a fixed dose combination of ICS/LABA was associated with higher COPD related exacerbation rates than those who did not switch.

Competing Interests

The authors declare no competing interest.

Additional information

Notes on contributors

Luca Degli Esposti

CliCon is a company specialized in designing and developing retrospective observational studies in collaboration with General Practitioners, Specialist Centers and Local Health Authorities (Regional and Local Health Units), using administrative and clinical databases. Founded in 1996 on a combination of skills in clinical medicine, health economics and information technology, today we are a multi-functional, project oriented organization capable of developing the entire range of activities required for an observational study.

Our mission is to support health stakeholders involved in the continuous improvement of clinical practice providing the capture of data on processes and outcomes, the analysis of the gap between expected and achieved results, the assessment of health technologies and economics, the dissemination of evidence and training, the development of cooperation between different stakeholders.