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Long-Term Safety of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease, a Multinational Observational
Edeltraut Garbe1, Fabian Hoti2, Tania Schink1
1Department Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
Roflumilast use in COPD patients showed no increased mortality risk in Sweden or Norway. A slight increase was seen in Germany and the US, possibly due to confounding factors.
Area of Science:
- Pulmonary Medicine
- Pharmacovigilance
- Epidemiology
Background:
- Chronic obstructive pulmonary disease (COPD) and chronic bronchitis necessitate long-term treatment strategies.
- Roflumilast is a phosphodiesterase-4 inhibitor used in managing COPD.
- Understanding the long-term safety profile of roflumilast, particularly regarding mortality, is crucial for clinical practice.
Purpose of the Study:
- To evaluate the long-term safety of roflumilast in patients with COPD or chronic bronchitis.
- To assess the association between roflumilast use and 5-year all-cause mortality across different countries.
Main Methods:
- Retrospective cohort study using electronic healthcare databases from Germany, Norway, Sweden, and the US.
- Inclusion of patients aged ≥40 years, with matched cohorts of roflumilast-exposed and unexposed individuals.
- Propensity score matching considered demographics, COPD severity, and comorbidities. Cox regression models analyzed 5-year all-cause mortality.
Main Results:
- 112,541 unexposed and 23,239 exposed patients were analyzed.
- In Germany and the US, 'ever use' of roflumilast was associated with a small increase in 5-year mortality risk (HRs > 1).
- Conversely, 'current use' of roflumilast showed a decreased 5-year mortality risk in Germany, Norway, and Sweden (HRs < 1).
Conclusions:
- No increased 5-year mortality risk was observed with roflumilast use in Sweden or Norway.
- A slight increase in mortality risk for 'ever use' in Germany and the US may be attributed to residual confounding by indication.
- Current roflumilast use was associated with reduced mortality in Germany, Norway, and Sweden, warranting further investigation.
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