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 FEV ₁ 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 FEV ₁ 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.
Competing Interests: Disclosure IM is a former employee of Takeda and a current employee of AstraZeneca. PK reports personal fees from Takeda during the conduct of the study; personal fees from AstraZeneca, Chiesi, GSK, Novartis, Menarini, Teva, and Mundipharma outside the submitted work. CV reports no relevant conflicts of interest in the current study, and the following relevant financial activities outside of the submitted work: personal fees from Almirall, Cipla, Berlin Chemie/Menarini, CSL Behring, and Teva; grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Mundipharma, Novartis, and Takeda; grants from German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Bayer Schering Pharma AG, MSD, and Pfizer. RS reports no conflicts of interest in this work. The authors report no other conflicts of interest in this work.