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Study Finds Benefit to Add-On Therapy for COPD

Allison Inserro
A study of a once-daily add-on medication for chronic obstructive pulmonary disease (COPD) found that it was associated with improvements in health status and quality of life.
A study of a once-daily add-on medication for chronic obstructive pulmonary disease (COPD) found that it was associated with improvements in health status and quality of life.

Data for the study, published in the International Journal of COPD, came from 2 trials in Germany and included 9000 patients from primary and secondary specialist respiratory care centers.

The 2 trials, called DINO and DACOTA, were prospective, noninterventional studies assessing the health status and quality of life of patients with severe COPD, newly treated with roflumilast 500 mcg taken once daily over 6 months. Patients answered a clinical COPD questionnaire (CCQ) and took a COPD assessment test (CAT); scores were recorded at baseline and after 3 and 6 months.

In DACOTA, postbronchodilator mean forced expiratory volume in 1 second (FEV1) was recorded at each time point.

Of the 5462 and 3645 patients recruited into DINO and DACOTA, respectively, 3274 patients in DINO and 916 patients in DACOTA completed the 6-month visit. Almost all patients had severe or very severe airway obstruction; mean baseline CCQ total score was 3.9 in DINO and 3.7 in DACOTA. Overall, 33.8% of patients in DACOTA and 30.6% in DINO discontinued treatment prematurely.

Significant improvements in CCQ total scores were observed in both studies. The mean change from baseline was 1.36 in DINO and 0.91 in DACOTA at 6 months [all P, 0.001].

Changes in CAT total score from baseline to month 6 indicated that the average clinical impact of COPD was reduced from a severe (score: 21–30) to a moderate impairment (score: 11–20).  In DACOTA, mean change in post-bronchodilator FEV1 was 202 mL (P, 0.001)

Diarrhea, nausea, and weight decrease were the most frequently reported adverse drug reactions.

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 (ICS). 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 an add-on treatment.

Roflumilast is sold under the name Daliresp. It is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

Reference

Kardos P, Mokros I, Sauer R, Vogelmeier CF. Health status in patients with COPD treated with roflumilast: two large noninterventional real-life studies: DINO and DACOTA. Int J Chron Obstruct Pulmon Dis. COPD 2018:13:1455–1468 doi.org/10.2147/COPD.S159827

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