“With both aclidinium doses, the incidence of anticholinergic adverse events was low and similar to placebo,” the authors comment.
Dr. Paul W. Jones, with the University of London, UK, and an international team note that aclidinium bromide is a novel inhaled long-acting muscarinic antagonist that was originally tested as a once-daily 200-mcg dose. A subsequent 2-week trial showed that BID dosing at 200 or 400 mcg gave better results.
The current study focus on that strategy continued for 24 weeks. Overall, 882 patients were randomized to twice-daily aclidinium (200 mcg or 400 mcg) or placebo.
Compared to placebo, trough FEV1 improved significantly more with both doses (99mL and 128 mL, respectively; both p<0.0001) at 24 weeks. Similarly, the corresponding differences in improvement in peak FEV1 were 185 mL and 209 mL (both p<0.0001), the investigators report. “Peak FEV1 improvements on Day 1 were comparable with Week 24,” they add.
Furthermore, the improvement from baseline in health status, based on the St George’s Respiratory Questionnaire (SGRQ), was -3.8 units with the 200-mcg dose relative to placebo (p=0.001) and -4.6 units with the 400-mcg dose (p=0.0001), the team observed.
Potential anticholinergic adverse effects were reported at an incidence of <1% in the 200-mcg and 400-mcg aclidinium groups and placebo group, except for urinary tract infection (0.7%, 2.2% and 0.7%, respectively), Dr. Jones and colleagues report.
They conclude, “Given the sustained bronchodilatory effect and low rate of anticholinergic effects, aclidinium BID may be an effective new LAMA (long-acting muscarinic antagonist) treatment option for patients with stable moderate or severe COPD, with the risk-benefit profile favouring the 400 mcg dose.”