medwireNews: Combination treatment with umeclidinium bromide and vilanterol (UMEC/VI) offers clinically meaningful improvements over tiotropium (TIO) monotherapy for patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD), study data show.
The researchers say that their findings suggest that UMEC/VI is a more effective bronchodilator than TIO and “are in line with previous studies”.
The team, led by M Reza Maleki-Yazdi (University of Toronto, Ontario, Canada), compared the long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) combination with TIO monotherapy in a multicentre, randomised, blinded, phase III clinical trial.
A total of 905 patients, aged 40 years and older, with moderate-to-very severe COPD were randomly assigned to receive once-daily, inhaled, fixed-dose UMEC/VI 62.5/25 µg or TIO 18 µg at 71 centres in eight countries.
Treatment with UMEC/VI resulted in a 0.205 L improvement from baseline in trough forced expiratory volume in 1 second (FEV1) at day 169, compared with a significantly smaller improvement of 0.093 L for TIO.
There was also a significantly greater improvement in the weighted mean FEV1 over 0–6 hours post-dose at day 168 with UMEC/VI versus TIO, at 0.276 versus 0.170 L.
Improvements in both outcome measures with UMEC/VI over TIO were observed as early as day 2 and were maintained at other clinic visits throughout the study, the researchers note in Respiratory Medicine.
Furthermore, although approximately 50% of patients in both treatment groups were taking inhaled corticosteroids (ICS), exploratory analyses suggested that there was no impact of ICS use on treatment effect for either outcome.
As well as clinical improvements, Maleki-Yazdi et al also observed significantly greater improvements in quality of life among the patients receiving UMEC/VI. At day 168, the St George’s Respiratory Questionnaire total score had fallen by 7.27 points in the UMEC/VI group, compared with a fall of 5.17 points in the TIO group, while the odds of being a responder (defined as a reduction of at least 4 points) were a significant 40% greater with UMEC/VI than with TIO.
Both treatments were well-tolerated and the incidence of on-treatment serious adverse events was low, at 4% for both groups, with none considered related to the study drugs.
“These results add to a growing body of evidence supporting the use of dual bronchodilator therapy over bronchodilator monotherapy in the management of symptomatic patients with COPD”, Maleki-Yazdi and co-authors conclude.
They add that additional studies of LABA/LAMA combinations in patients with differing severities of COPD, as well as in combination with ICS, would be useful “to further characterize the benefit of this combination in clinical practice”.
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By Laura Cowen, medwireNews Reporter