June 20, 2018
When used as add-on therapy, daily Daliresp (roflumilast; AstraZeneca) significantly improved health status and quality of life in patients with chronic obstructive pulmonary disease (COPD), according to a new study in the International Journal of Chronic Obstructive Pulmonary Disease.
"Many patients with COPD continue to suffer exacerbations and recurrent hospitalizations despite treatment with long-acting muscarinic antagonists (LAMA), long-acting beta‑agonists (LABA), and inhaled corticosteroids,” Peter Kardos, MD, of the Group Practice and Centre for Allergy, Respiratory, and Sleep Medicine at the Maingau Red Cross Hospital in Frankfurt, Germany, and colleagues wrote. “Roflumilast is a selective phosphodiesterase-4 (PDE4) inhibitor recommended for maintenance treatment of COPD in patients with post-bronchodilator FEV1,50% predicted, associated with chronic bronchitis and a history of exacerbations, as add-on to inhaled therapies."
Researchers came to these findings after assessing data from a pair of prospective, noninterventional trials in Germany, DINO and DACOTA, which gauged the effect of 500 mcg daily add-on roflumilast over 6 months on 9107 patients with severe or very severe COPD. Some 4190 patients completed the 6-month visit.
After 6 months of roflumilast add-on therapy, researchers observed significant and clinically relevant gains in total scores on the clinical COPD questionnaire (CCQ). From mean baseline scores of 3.9 in DINO and 3.7 in DACOTA, mean CCQ scores changed 1.36 in DINO and 0.91 in DACOTA.
Furthermore, 6 months of roflumilast dropped average COPD impairment from severe to moderate, COPD assessment test (CAT) scores indicated. Postbronchodilator forced expiratory volume in 1 second (FEV1) saw a mean change of 202 mL in DACOTA.
About a third of patients in each study discontinued treatment prematurely. The most frequently reported adverse drug reactions were diarrhea, nausea, and weight loss.
“Despite the known limitations of noninterventional studies,” researchers wrote, “the results of these 2 independent observational studies are encouraging and demonstrate that roflumilast add-on therapy improves quality of life in patients with COPD in a real-life clinical setting.”
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