Long-term safety and efficacy of twice-daily aclidinium bromide in patients with COPD

Background: Aclidinium is a novel, long-acting muscarinic antagonist indicated for maintenance treatment of COPD. Methods: In this 52-week, parallel-group, double-blind study, patients with moderate-to-severe COPD were randomized (1:1) to receive aclidinium twice-daily (BID) 200 mu g or 400 mu g via a novel, dry powder inhaler (Genuair (R)/Pressair (R)) [Registered trademarks of Almirall, SA, Barcelona, Spain for use within the European Union, Iceland, Norway, and Switzerland as Genuair (R) and within the United States as Pressair (R)]. Safety, the primary objective, was assessed via adverse events (AEs), clinical laboratory tests, vital signs, and 12-lead electrocardiograms. Efficacy was evaluated using spirometry, SGRQ, and rescue medication use. Results: A total of 605 patients were randomized in the study. The percentage of patients reporting any treatment-emergent AE (TEAE) was comparable between groups; most TEAEs were mild or moderate. Anticholinergic TEAEs were reported by low percentages of patients in either treatment group (dry mouth: 200 mu g, 1.3%; 400 mu g, 2.7%; constipation: 200 mu g, 2.9%; 400 mu g, 1.7%). Cardiac TEAEs were also reported by a low percentage of patients (<2% for any event in any group) and did not appear to be dose dependent. There were no clinically relevant abnormalities in other safety outcomes. Both aclidinium 200 mu g and 400 mu g resulted in improvements from baseline to Week 52 in FEV1, with numerically greater increases observed with the higher dose. Clinically important improvements in SGRQ scores and a reduction in rescue medication use were observed throughout the study for both doses. Conclusions: Long-term treatment with aclidinium 200 mu g or 400 mu g BID was well tolerated, with sustained benefits in lung function and health status in patients with COPD throughout the 1-year study. (C) 2013 Elsevier Ltd. All rights reserved.