Efficacy and safety profile of roflumilast in a real-world experience

Roflumilast is the only phosphodiesterase enzyme 4 inhibitor approved in the treatment of chronic obstructive pulmonary disease (COPD) patients with chronic cough and sputum and a history of exacerbations. Real-world studies about the use of roflumilast are limited. Our aim was to assess the efficacy, safety and tolerability of roflumilast in the treatment of stable COPD, in a real-world setting.

From August 2014 to August 2017, medical records of all COPD patients who were prescribed roflumilast therapy in Akdeniz University Hospital were analyzed retrospectively. COPD patients were studied in terms of efficacy, safety, and drug discontinuation rate. Efficacy was evaluated as the effect of roflumilast on exacerbation and hospitalization rates of COPD compared to the pre-treatment period.

Eighty-three COPD patients treated with roflumilast were included (mean age 66.2±9.3 years, 88.0% male). All the patients were chronic bronchitis and frequent exacerbator clinical phenotype and were classified in the Global Initiative for Chronic Obstructive Lung Disease categories C (n=17; 20.5%) and D (n=66; 79.5%). Mean duration of roflumilast use was 18.9±10.4 months. There was a significant decrease in both COPD exacerbations (2.7 vs. 1.16; P<0.001) and hospitalizations (0.77 vs. 0.32; P<0.001) in roflumilast users compared to the pre-treatment period. Of the patients, 22 (26.5%) experienced adverse events (AE) during their treatment period. The most frequently reported AEs were weight loss (10.8%), loss of appetite (10.8%) and nausea (8.4%). Serious or life-threatening AEs were not detected. Sixteen (19.3%) patients discontinued roflumilast because of AEs.

Roflumilast reduced exacerbations and hospitalizations in our real-world population with severe COPD. AEs are common and frequently leading to discontinuation of roflumilast therapy.