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KMID : 0869620150320040308
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Journal of Korean Society of Hospital Pharmacists
2015 Volume.32 No. 4 p.308 ~ p.317
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Clinical Use of Roflumilast in Chronic Obstructive Pulmonary Disease
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Park You-Kyung
Han Young-Hyun
Han Ok-Youn
La Hyen-O
Wee Wan-Joo
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Abstract
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Background : Roflumilast is a selective phosphodiesterase (PDE)-4 inhibitor approved
for treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis
and patients with a history of exacerbation. It improves lung function and reduces the frequency
of exacerbation in patients with severe COPD. However, high rates of adverse events such as
diarrhea and nausea have been reported in clinical trials. The purpose of this study was to investigate
the pattern of roflumilast usage, tolerability, and adverse events in clinical practice.
Methods : We retrospectively analyzed the medical records of patients who received roflumilast
between December 2012 and September 2013.
Results : Roflumilast was prescribed for 88 COPD patients. Initially, 49 patients (55.7%) received 500
mcg and 39 patients (44.3%) received 250 mcg once daily. For 64 patients, roflumilast was prescribed
for maintenance of severe COPD (post-bronchodilation forced expiratory volume (FEV1) ≤50%),
which is associated with chronic bronchitis in adult patients with a history of exacerbations as an
add-on to bronchodilator treatment. Roflumilast-related adverse events were observed in 47.73%
(40/88) of the overall population (62 cases). The most common adverse events were gastrointestinal
issues, including diarrhea, nausea, GI trouble, and decrease in appetite. Other adverse events included
weight loss, skin reactions, headaches, and insomnia. Only 38 patients (43.18%) completed 1 year
of roflumilast therapy and treatment discontinuation occurred in 50 patients (56.82%). Adverse
events are the leading cause of treatment discontinuation.
Conclusions : Roflumilast, in conjunction with standard therapy, caused more adverse events than
has previously been reported. The long-term safety and efficacy of roflumilast has not been evaluated
fully, and serious adverse events should be closely monitored.
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KEYWORD
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Roflumilast, Phosphodiesterase-4 inhibitor, Adverse events, COPD exacerbation
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