만성 폐쇄성 폐질환 환자에서 Roflumilast 약물 사용 평가
Clinical Use of Roflumilast in Chronic Obstructive Pulmonary Disease
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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.
Abstract
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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