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Basic Clin Pharmacol Toxicol. 2018 Sep;123(3):314-319. doi: 10.1111/bcpt.13014. Epub 2018 May 4.

Roflumilast Usage from 2010 to 2016: A Danish Nationwide Drug Utilization Study.

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Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark.
Department of Public Health, Clinical Pharmacology and Pharmacy, University of Southern Denmark, Odense, Denmark.
Department of Clinical Biochemistry & Pharmacology, Odense University Hospital, Odense, Denmark.


Roflumilast, a phosphodiesterase-4-inhibitor, is marketed as add-on treatment to inhaled bronchodilators and corticosteroids in COPD patients with frequent exacerbations. Although marketed since 2010, usage pattern of roflumilast for an entire nation has not previously been explored. This study aimed to estimate the total utilization of roflumilast in Denmark during 2010 to 2016, using the Danish nationwide health registers. We identified 1573 individuals (47% males) who used roflumilast during the study period, of whom 705 (45%) redeemed only one prescription. Of all patients initiating roflumilast, 67% discontinued treatment within the first year. The rate of treatment initiation decreased 73% from 2011 (7.5/100,000 person-years) to 2016 (2.0/100,000 person-years) concurrent with a stable prevalence of 3.0-4.0/100,000 persons throughout the study period. The median duration of roflumilast use was 76 days. Patients with severe comorbidity tended to exhibit a lower degree of early discontinuation (Charlson Comorbidity Index 3+: odds ratio [OR]: 0.59; 95% confidence interval [CI] 0.33-1.04), as well as patients with a COPD-related admission within a year prior to roflumilast initiation (OR 0.62; 95% CI 0.49-0.80). The decreasing incidence and high level of early roflumilast discontinuation could be due to lack of benefit, a low awareness of romiflulast's indication among physicians, secondary to a challenging prescribing procedure or to adverse effects.

[Indexed for MEDLINE]

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