Combination treatment with umeclidinium (UMEC) plus vilanterol (VI) improves lung function in patients with chronic obstructive pulmonary disease (COPD) to a greater extent than with VI or tiotropium (TIO) monotherapy, results show.
The findings, from two large 6-month randomised studies, suggest that this combination of a long-acting muscarinic antagonist (LAMA) – UMEC – and long-acting β2 agonist (LABA) – VI –could be beneficial for the treatment of moderate to very severe COPD, says the team.
The study participants were current or former smokers aged 40 years or older who had an established clinical history of COPD.
In study 1, the intention-to-treat analyses included 208 patients receiving TIO 18 µg monotherapy, 209 receiving VI 25 µg monotherapy, 214 UMEC 125 µg plus VI 25 µg and 212 UMEC 62.5 µg plus VI 25 µg. The drugs were taken daily for 24 weeks.
Improvements in trough forced expiratory volume in 1 second (FEV1) on day 169 were significantly greater with the combination therapy than with either monotherapy, with a 0.088 L difference with UMEC 125 µg plus VI and 0.090 L with UMEC 62.5 µg plus VI.
The findings were similar in study 2, with patients who received UMEC 125 µg plus VI 25 µg (n=215) or UMEC 62.5 µg plus VI 25 µg (n=217) experiencing a superior improvement in FEV1 on day 169 to that of patients receiving TIO monotherapy (n=215), at 0.060 to 0.074 L depending on the UMEC dose.
However, there was no significant difference when the combination was compared with UMEC 125 µg monotherapy in 222 patients. Yet, the researchers note in The Lancet Respiratory Medicine that there were “larger improvements in other lung function endpoints with the combination treatment.”
All the treatments produced meaningful improvements in dyspnoea and health-related quality of life and there were no significant differences in symptoms, health status or risk of COPD exacerbation between the UMEC plus VI and TIO groups.
The beneficial effects of combination therapy on lung function did not come at the expense of an increase in adverse events, the researchers Marc Decramer (University of Leuven, Belgium) and colleagues highlight.
On-treatment adverse events were comparable across the groups, with the proportion of patients reporting one or more events ranging from 39% to 51% in study 1, and from 59% to 62% in study 2.
Nasopharyngitis and headache were the two most common adverse events and acute COPD exacerbation the most common serious adverse event.
None of the treatments had a substantial effect on pulse rate, blood pressure or electrocardiogram parameters.
“These data support the use of once-daily umeclidinium plus vilanterol to increase lung function in patients with moderate to very severe COPD”, the researchers conclude.
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