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Safety Profile of Roflumilast in a Real Life Experience
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A3039 - Safety Profile of Roflumilast in a Real Life Experience
Author Block: A. Cilli, H. Dirol, H. Bal; Akdeniz University School of Medicine, Antalya, Turkey.
RATIONALE: It is still difficult to judge whether or not the benefits of roflumilast outweigh the harms. Real-life studies about the use of roflumilast are limited. Our aim was to assess the safety of roflumilast in the treatment of stable chronic obstructive pulmonary disease (COPD), in a real life setting. METHODS: In this retrospective cohort study, consecutive COPD patients treated with roflumilast were studied in terms of safety, adverse effects (AEs) and drug discontinuation rate. RESULTS: Eighty-three COPD patients treated with roflumilast were included (mean age 66.2 years, 88% men). All the patients were chronic bronchitis and frequent exacerbator clinical phenotype and were classified into Global Initiative for Chronic Obstructive Lung Disease (GOLD) groups C (n=17; 20.5%) and D (n=66; 79.5%). Mean duration of roflumilast use was 18 months. Of these patients, 22 (26.5%) experienced AEs during their treatment period. The most frequently reported AEs were gastrointestinal symptoms (18.6%), weight loss (10.5 %), and psychiatric symptoms (8.1%). Serious or life-threatening AEs were not detected. Sixteen (19.2%) patients discontinued roflumilast because of AEs. CONCLUSIONS: This study showed, in a real life setting, increased risk of side effects associated with roflumilast use which leads to discontinuation of treatment.
Author Block: A. Cilli, H. Dirol, H. Bal; Akdeniz University School of Medicine, Antalya, Turkey.
RATIONALE: It is still difficult to judge whether or not the benefits of roflumilast outweigh the harms. Real-life studies about the use of roflumilast are limited. Our aim was to assess the safety of roflumilast in the treatment of stable chronic obstructive pulmonary disease (COPD), in a real life setting. METHODS: In this retrospective cohort study, consecutive COPD patients treated with roflumilast were studied in terms of safety, adverse effects (AEs) and drug discontinuation rate. RESULTS: Eighty-three COPD patients treated with roflumilast were included (mean age 66.2 years, 88% men). All the patients were chronic bronchitis and frequent exacerbator clinical phenotype and were classified into Global Initiative for Chronic Obstructive Lung Disease (GOLD) groups C (n=17; 20.5%) and D (n=66; 79.5%). Mean duration of roflumilast use was 18 months. Of these patients, 22 (26.5%) experienced AEs during their treatment period. The most frequently reported AEs were gastrointestinal symptoms (18.6%), weight loss (10.5 %), and psychiatric symptoms (8.1%). Serious or life-threatening AEs were not detected. Sixteen (19.2%) patients discontinued roflumilast because of AEs. CONCLUSIONS: This study showed, in a real life setting, increased risk of side effects associated with roflumilast use which leads to discontinuation of treatment.
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