Two long-acting muscarinic antagonists got comparable results in a trial with COPD patients.
The drugs umeclidinium and glycopyrronium have similar effects in treating chronic obstructive pulmonary disease (COPD) a new study has found.
The research was conducted by Tara Rheault, PhD, Senior Director, Drug Development Lead, at Quintiles, and colleagues, and was published in ERJ Open Research on April 27, 2016.
There were 1,037 participants in this randomized, 12-week, multi-center, open-label, parallel-group study, designed to compare two long acting muscarinic antagonists (LAMAs): umeclidinium (UMEC) and glycopyrronium (GLYCO). Other LAMAs that are used in COPD are tiotropium and aclidinium. The only two that are currently approved for once-daily use in the US are UMEC and TIO.
The authors say, “Randomized controlled trials directly comparing LAMAs are few in number,” and go on to say that in one study GLYCO had been shown to be “non-inferior in terms of lung function to TIO.” They add that some meta-analyses have been conducted in an attempt to compare how well the LAMAs work, but say, “This study is the first to formally compare the efficacy and safety” of UMEC with GLYCO.
Patients were randomized on a 1:1 basis to receive either UMEC once per day or GLYCO once per day. “The primary endpoint was trough FEV1 on day 85,” said the researchers, though they also considered some other measures, including trough FVC at days 2, 28, 56, and 84, as well as breathlessness, health related quality of life (HRQoL), and rescue-medication use.
The researchers also note, “If non-inferiority was demonstrated, but not superiority, then the statistical significance of other lung-function endpoints could not be inferred. However, the primary endpoint of trough FEV1 was considered to be independent of the non-lung function endpoints.”
On day 85, the researchers found that “UMEC was non-inferior to GLYCO because the lower bound for the 95% confidence interval for the comparison was above the non-inferiority margin.” Adverse events were similar for both groups, with two deaths in each group, and 9% of the UMEC group had exacerbations, while 10% of the GLYCO group did.
The researchers note, “the main limitation of this study was its open label design, which may have resulted in some degree of bias as patients and study site investigators were aware of the study treatments used.”