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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.
Respir Med 2014; 108(12):1752-60RM

Abstract

BACKGROUND

Combinations of inhaled long-acting bronchodilator therapies such as muscarinic antagonists and β2-agonists may be more effective than monotherapy in the treatment of chronic obstructive pulmonary disease (COPD).

METHODS

This study was a 24-week, Phase III, multicenter, randomized, blinded, double-dummy, parallel-group study of the once-daily, inhaled, fixed-dose combination of the long-acting muscarinic antagonist umeclidinium bromide and the long-acting β2-agonist vilanterol (UMEC/VI 62.5/25 mcg) versus tiotropium (TIO, 18 mcg). The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at Day 169. The secondary endpoint was weighted mean FEV1 over 0–6 h post-dose at Day 168. For key endpoints, a step-down closed testing hierarchy was applied to account for multiplicity. Other efficacy and safety endpoints were assessed.

RESULTS

Statistically significant improvements in trough FEV1 at Day 169 (0.112 L, 95% confidence interval [CI]: 0.081, 0.144; p < 0.001) and weighted mean FEV1 over 0–6 h post-dose at Day 168 (0.105 L, 95% CI: 0.071, 0.140; p < 0.001) were observed for UMEC/VI versus TIO. In addition UMEC/VI improved health-related quality of life, and reduced requirement for the use of rescue medication compared with TIO. The incidence of adverse events was similar between treatment groups.

CONCLUSIONS

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.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25458157

Citation

Maleki-Yazdi, M Reza, et al. "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." Respiratory Medicine, vol. 108, no. 12, 2014, pp. 1752-60.
Maleki-Yazdi MR, Kaelin T, Richard N, et al. 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. Respir Med. 2014;108(12):1752-60.
Maleki-Yazdi, M. R., Kaelin, T., Richard, N., Zvarich, M., & Church, A. (2014). 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. Respiratory Medicine, 108(12), pp. 1752-60.
Maleki-Yazdi MR, et al. 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. Respir Med. 2014;108(12):1752-60. PubMed PMID: 25458157.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Maleki-Yazdi,M Reza, AU - Kaelin,Thomas, AU - Richard,Nathalie, AU - Zvarich,Michael, AU - Church,Alison, PY - 2014/06/27/received PY - 2014/09/09/revised PY - 2014/10/06/accepted PY - 2014/12/3/entrez PY - 2014/12/3/pubmed PY - 2015/7/15/medline SP - 1752 EP - 60 JF - Respiratory medicine JO - Respir Med VL - 108 IS - 12 N2 - BACKGROUND: Combinations of inhaled long-acting bronchodilator therapies such as muscarinic antagonists and β2-agonists may be more effective than monotherapy in the treatment of chronic obstructive pulmonary disease (COPD). METHODS: This study was a 24-week, Phase III, multicenter, randomized, blinded, double-dummy, parallel-group study of the once-daily, inhaled, fixed-dose combination of the long-acting muscarinic antagonist umeclidinium bromide and the long-acting β2-agonist vilanterol (UMEC/VI 62.5/25 mcg) versus tiotropium (TIO, 18 mcg). The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at Day 169. The secondary endpoint was weighted mean FEV1 over 0–6 h post-dose at Day 168. For key endpoints, a step-down closed testing hierarchy was applied to account for multiplicity. Other efficacy and safety endpoints were assessed. RESULTS: Statistically significant improvements in trough FEV1 at Day 169 (0.112 L, 95% confidence interval [CI]: 0.081, 0.144; p < 0.001) and weighted mean FEV1 over 0–6 h post-dose at Day 168 (0.105 L, 95% CI: 0.071, 0.140; p < 0.001) were observed for UMEC/VI versus TIO. In addition UMEC/VI improved health-related quality of life, and reduced requirement for the use of rescue medication compared with TIO. The incidence of adverse events was similar between treatment groups. CONCLUSIONS: 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. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/25458157/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(14)00334-5 DB - PRIME DP - Unbound Medicine ER -