Long-Term Safety of Roflumilast in Adults with COPD: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On September 6, 2024, we reported on a study published in the International Journal of Chronic Obstructive Pulmonary Disease that examined 5-year all-cause mortality among adults 40 years and older with chronic obstructive pulmonary disease (COPD) or chronic bronchitis (CB) receiving roflumilast in a real-world setting.

The study

Researchers conducted the study using data from nationwide registries from Sweden and Norway and medical claims databases from Germany (German Pharmacoepidemiological Research Database) and the US (Military Health System). All databases contain historical data for patient care and drug dispensations. They matched patients 40 years or older with COPD or CB with a first-time roflumilast exposure in one of the cohort entry years (2010-2013; exposed cohort) to roflumilast-unexposed patients with COPD or CB (unexposed cohort).

Matching was based on age, sex, propensity score (PS), and calendar year of the cohort entry date (CED). Exposed patients were matched with up to 5 unexposed patients, and each yearly cohort was followed up for at least 5 years. After matching, the study population consisted of 135 856 patients, with 23 239 in the exposed cohort.

The findings

Investigators observed a small 5-year mortality risk increase among patients with COPD in Germany and the US who used roflumilast but not among those in Sweden or Norway.

Authors' comment

“The generalizability of the study results is supported by its real-world setting and by the representativeness of its data from the Norwegian and Swedish national registries and large population samples from Germany and the US.”

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