Health status in patients with COPD treated with roflumilast: two large noninterventional real-life studies: DINO and DACOTA

  • Purpose: DINO and DACOTA were prospective, noninterventional studies assessing the health status and quality of life of patients with COPD newly treated with roflumilast 500 µg once-daily add-on therapy. Patients and methods: Patients were evaluated over 6 months. Clinical COPD questionnaire (CCQ) and COPD assessment test (CAT) scores were recorded at baseline and after 3 and 6 months. In DACOTA, post-bronchodilator FEV1 was recorded at each time point. Results: Of 5,462 and 3,645 patients recruited into DINO and DACOTA, respectively, 3,274 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 and clinically relevant improvements in CCQ total scores were observed in both studies (mean change from baseline of 1.36 in DINO and 0.91 in DACOTA at Month 6 [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 (score: 11–20) impairment. 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. Conclusion: In real-life clinical practice, roflumilast treatment as an add-on therapy is associated with clinically relevant improvements in health status and quality of life.
Author:Peter KardosORCiDGND, Ingo Mokros, Rüdiger Sauer, Claus F. Vogelmeier
Pubmed Id:
Parent Title (English):The International journal of chronic obstructive pulmonary disease
Publisher:DOVE Medical Press
Place of publication:Albany, Auckland
Contributor(s):Richard Russell
Document Type:Article
Year of Completion:2018
Date of first Publication:2018/05/03
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2018/05/29
Tag:COPD assessment test; clinical COPD questionnaire; lung function; observational study; phosphodiesterase-4 inhibitor; quality of life; roflumilast
Page Number:14
First Page:1455
Last Page:1468
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Institutes:keine Angabe Fachbereich / Extern
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell 3.0