Overall and cardiovascular safety of aclidinium/formoterol fixed-dose combination versus salmeterol/fluticasone in patients with COPD

Background: Aclidinium bromide/formoterol fumarate fixed-dose combination (FDC) twice daily (BID) is approved in Europe for the treatment of COPD. Aim: To evaluate overall and cardiovascular (CV) safety of aclidinium/formoterol FDC vs salmeterol/fluticasone propionate FDC in patients with COPD. Methods: Safety data were analysed from a 24-week, randomised, double-blind, Phase IIIb study of aclidinium/formoterol 400/12 µg BID or salmeterol/fluticasone 50/500 µg BID in patients with COPD (NCT01908140). Adverse events (AEs) were monitored, including cardiac, cerebrovascular and serious AEs (SAEs). Laboratory tests and electrocardiograms (ECG) were recorded. Results: The safety population included 933 patients: mean age 63.4 years; 65.1% male. At baseline 52.8% had hypertensive disorders, 11.8% had diabetes and 21.8% had cardiac disorders. Incidence of AEs and SAEs was similar across groups (Table). Incidence of cardiac and cerebrovascular AEs was low in both groups (Table). AEs related to inhaled corticosteroids (ICS) were more common in patients receiving salmeterol/fluticasone than in the aclidinium/formoterol group (Table). Laboratory and ECG results were similar across groups. Conclusions: Aclidinium/formoterol and salmeterol/fluticasone FDCs were well tolerated in patients with COPD. Incidence of CV AEs was low.