Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: Results of a 24-week, randomized, controlled trial

Abstract

UMEC/VI was associated with statistically significant and clinically meaningful improvements in lung function versus TIO. UMEC/VI was well tolerated. UMEC/VI 62.5/25 mcg could provide an effective new treatment option for patients with moderate-to-very severe COPD.

A Network Meta-Analysis of Long-Acting Muscarinic Antagonist (LAMA) and Long-Acting β2-Agonist (LABA) Combinations in COPD

“…LABA combination therapy compared with TIO monotherapy are consistent with results from several RCTs which directly compared various LAMA ? LABA therapies with TIO [14][15][16][17][18][19][20]. This observation is therefore not unexpected and could be attributed to the direct agonist effect of the added LABA, as well as possible synergistic effects [13].…”

“…In the last decade, multiple randomized controlled trials (RCTs) have reported that improvements in lung function and patient-reported outcomes (PROs) can be achieved with LAMA ? LABA combinations compared with the component monotherapies for patients with stable COPD, with no differences in safety [14][15][16][17][18][19][20].…”

The clinical relevance of the emphysema-hyperinflated phenotype in COPD

“…These combinations are at least as effective as the simultaneous use of their individual components (possibly via a synergistic effect [137,138]) and significantly improve lung function compared with monotherapy [139][140][141][142][143][144][145]. A positive effect on exercise tolerance has also been demonstrated for indacaterolglycopyrronium and vilanterol-umeclidinium compared with placebo [146,147], although the magnitude of this effect was less when compared to monotherapy with tiotropium.…”

Management of Chronic Obstructive Pulmonary Disease: A Personalized Interpretation of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) - ABCD Recommendations

“…For patients at greater risk of exacerbations (GOLD C and D), inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA) combination therapies are a firstchoice option, alongside long-acting muscarinic antagonist (LAMA) monotherapy, in order to prevent future exacerbations. The recent introduction of LABA/LAMA combinations provides another treatment option for GOLD B, C, and D patients; these drugs provide a greater effect on lung function than long-acting bronchodilator monotherapies [28][29][30][31][32][33][34][35][36][37] and a benefit on symptoms, although the magnitude of effect observed in clinical trials has been smaller than the expected combined effect of the component monotherapies 38 . Roflumilast is a phosphodiesterase 4 inhibitor that reduces exacerbation rates in COPD patients with chronic bronchitis, FEV 1 < 50% predicted, and a history of exacerbations 39 ; consequently, this drug is recommended as a treatment option for appropriate GOLD C and D patients.…”

“…The development of LABA/LAMA combination inhalers has led to the publication of a number of well-powered clinical trial studies designed for regulatory purposes [28][29][30][31][32][33][34][35][36][37] . These studies have generally been performed in patient populations with a low rate of exacerbations, and consequently the interpretation of the benefit on exacerbations compared to monotherapy is limited.…”