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Chronic obstructive pulmonary disease: efficacy and safety of Umeclidinium plus Vilanterol versus Tiotropium, Vilanterol, or Umeclidinium monotherapies over 24 weeks


Combination long-acting bronchodilator treatment might be more effective than long-acting bronchodilator monotherapy for the treatment of chronic obstructive pulmonary disease ( COPD ).
A study has compared the efficacy and safety of Umeclidinium plus Vilanterol ( Anoro ) with Tiotropium ( Spiriva ) monotherapy, Umeclidinium monotherapy ( Incruse ), or Vilanterol monotherapy in patients with moderate to very severe chronic obstructive pulmonary disease.

In two multicentre, randomised, blinded, double-dummy, parallel-group, active-controlled trials, eligible patients ( current or former smokers aged 40 years or older with an established clinical history of chronic obstructive pulmonary disease ) were randomly assigned in 1:1:1:1 ratio to Umeclidinium 125 mcg plus Vilanterol 25 mcg, Umeclidinium 62.5 mcg plus Vilanterol 25 mcg, Tiotropium 18 mcg, and either Vilanterol 25 mcg ( study 1 ) or Umeclidinium 125 mcg ( study 2 ).
All study drugs were used once daily for 24 weeks.
Tiotropium was delivered via the HandiHaler inhaler and all other active treatments were delivered via the Ellipta dry powder inhaler.
Random assignment ( by a validated computer-based system ) was done by centre and was not stratified. All patients and physicians were masked to assigned treatment during the studies.

The primary efficacy endpoint of both studies was trough forced expiratory volume in 1 s ( FEV1 ) on day 169, which was analysed in the intention-to-treat population.

1141 participants were recruited in study 1, and 1191 in study 2.

For study 1, after exclusions, 208, 209, 214, and 212 patients were included in the intention-to-treat analyses for Tiotropium monotherapy, Vilanterol monotherapy, Umeclidinium 125 mcg plus VI 25 mcg, and Umeclidinium 62.5 mcg plus Vilanterol 25 mcg, respectively.
For study 2, 215, 222, 215, and 217 patients were included in the intention-to-treat analyses for Tiotropium monotherapy, Umeclidinium monotherapy, Umeclidinium 125 mcg plus Vilanterol 25 mcg, and Umeclidinium 62.5 mcg plus Vilanterol 25 mcg, respectively.

In both studies, researchers have noted improvements in trough FEV1 on day 169 for both doses of Umeclidinium plus Vilanterol compared with Tiotropium monotherapy ( study 1, Umeclidinium 125 mcg plus Vilanterol 25 mcg: 0.088 L [ p=0.0010 ]; study 1, Umeclidinium 62.5 mcg plus Vilanterol 25 mcg: 0.090 L [ p=0.0006 ]; study 2, Umeclidinium 125 mcg plus Vilanterol 25 mcg: 0.074 L [ p=0.0031 ]; study 2, Umeclidinium 62.5 mcg plus Vilanterol 25 mcg: 0.060 L [ nominal p=0.0182 ] ).

Both doses of Umeclidinium plus Vilanterol also improved trough FEV1 compared with Vilanterol monotherapy ( Umeclidinium 125 mcg plus Vilanterol 25 mcg: 0.088 L [ p=0.0010 ]; Umeclidinium 62.5 mcg plus Vilanterol 25 mcg: 0.090 L [ p=0.0006 ], but not compared with Umeclidinium 125 mcg monotherapy ( Umeclidinium 125 mcg plus Vilanterol 25 mcg: 0.037 L [ p=0.14 ]; Umeclidinium 62.5 mcg plus Vilanterol 25 mcg: 0.022 L [ p=0.38 ] ).

All treatments have produced improvements in dyspnoea and health-related quality of life; researchers noted no significant differences in symptoms, health status, or risk of exacerbation between Umeclidinium plus Vilanterol and Tiotropium.

The most common on-treatment, severe-intensity adverse event in both studies was acute exacerbation of chronic obstructive pulmonary disease ( 1-4 [ less than 1-2% ] patients across treatment groups in study 1 and 1-6 [ less than 1-3% ] patients in study 2 ).

Researchers recorded five to 15 ( 2-7% ) on-treatment serious adverse events across treatment groups in study 1, and nine to 22 ( 4-10% ) in study 2.
They noted no substantial changes from baseline in vital signs, clinical laboratory findings, or electrocardiography findings in any of the treatment groups.

In conclusion, combination treatment with once-daily Umeclidinium plus Vilanterol improved lung function compared with Vilanterol monotherapy and Tiotropium monotherapy in patients with chronic obstructive pulmonary disease.
Overall results suggest that the combination of Umeclidinium plus Vilanterol could be beneficial for the treatment of moderate to very severe chronic obstructive pulmonary disease. ( Xagena )

Decramer M et al, The Lancet Respiratory Medicine 2014; 2: 472-486

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