OBJECTIVES: Roflumilast is a non-first-line medication for adults with Chronic Obstructive Pulmonary Disease (COPD) and is associated with multiple side effects, which can affect its long-term use. This study aims to describe the persistence and adherence of roflumilast in patients with COPD.

METHODS: A cohort of patients aged ≥40 years diagnosed with COPD who newly initiated roflumilast from March 2011 to September 2015, were identified from the Truven MarketScan database. We measured demographic and clinical characteristics in the 12-month period prior to first date of use, the index date. Adherence was measured using prescription days covered (PDC) ≥ 80% threshold over a 6-month period. We calculated persistence as the proportion of patients that did not discontinue roflumilast, defined as a gap of >30 days.

RESULTS: A total of 9919 patients were included with a mean age of 67.7 years (±10.1) and 4972 (50.1%) were female. Inhaled corticosteroids (ICS) and long-acting beta agonists (LABA), single inhaler use or in combination, were frequently used, 7300 (73.6%) and 7073 (71.3%) respectively, in the baseline period. We also captured multiple COPD medication use prior to the index date. Accordingly, LABA and ICS 6903 (69.6%) were commonly prescribed followed by long acting muscarinic antagonists (LAMA) and ICS (5112, 51.5%). The overall PDC over a 6-month period was 69% with only 3104 (48.8%) patients being adherent (PDC≥ 80%). Over the same 6-month period, only 2581 (26.0%) were persistent. We also measured PDC over 3-month (81%) and 12-month (56%). In addition, persistence to roflumilast was 4899 (49.4%) and 1196 (12.1%) over a 3- and 12-month period respectively.

CONCLUSIONS: A substantial number of adult patients with COPD have sub-optimal adherence and persistence to roflumilast. Reasons for low adherence or discontinuation such as prevalence of treatment-related adverse effects deserve further investigation.