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Prevention of clinically important deteriorations in COPD with umeclidinium/vilanterol.

Abstract

BACKGROUND

Minimizing the risk of disease progression and exacerbations is the key goal of COPD management, as these are well-established indicators of poor COPD prognosis. We developed a novel composite end point assessing three important aspects (lung function, health status, and exacerbations) of worsening in COPD. The objective was to determine whether dual bronchodilation with umeclidinium/vilanterol (UMEC/VI) reduces clinically important deteriorations (CIDs) in COPD versus placebo or bronchodilator monotherapy.

METHODS

This study is a post hoc analysis of two 24-week trials comparing UMEC/VI 62.5/25 µg with UMEC 62.5 µg, VI 25 µg, or placebo (Study A; NCT01313650), or UMEC/VI 62.5/25 µg with tiotropium (TIO) 18 µg (Study B; NCT01777334) in patients with symptomatic COPD, without a history of frequent exacerbations. Deterioration was assessed as the time to a first CID, a composite measure defined as a decrease of ≥100 mL in trough forced expiratory volume in 1 second or ≥4-unit increase in St George's Respiratory Questionnaire total score or an on-treatment moderate-to-severe COPD exacerbation.

RESULTS

In Study A, fewer patients experienced a first CID with UMEC/VI (44%) versus UMEC (50%), VI (56%), and placebo (75%). The risk of a first CID was reduced with UMEC/VI (hazard ratio [HR]: 0.37 [95% confidence interval, CI: 0.30, 0.45]), UMEC (HR: 0.46 [95% CI: 0.38, 0.56]), and VI (HR: 0.55 [95% CI: 0.45, 0.66]; all P<0.001) versus placebo, and with UMEC/VI versus UMEC (HR: 0.80 [95% CI: 0.65, 0.97]; P<0.05) and versus VI (HR: 0.67 [95% CI: 0.55, 0.81]; P<0.001). In Study B, fewer patients experienced a first CID with UMEC/VI (41%) versus TIO (59%). UMEC/VI reduced the risk of a first composite CID by 43% versus TIO (HR: 0.57 [95% CI: 0.47, 0.69]; P<0.001).

CONCLUSION

This exploratory analysis, using a new assessment of clinical deterioration in COPD, revealed that a majority of symptomatic patients with low exacerbation risk experienced a deterioration during the 24-week study periods. UMEC/VI reduces the risk of a first CID versus placebo or bronchodilator monotherapy.

Authors+Show Affiliations

Medicines Evaluation Unit, University of Manchester, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.Division of Respiratory Medicine, Women's College Hospital, University of Toronto, ON, Canada.Precise Approach LTD, London UK.Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.Respiratory Medicines Development Centre, GSK, Stockley Park, Middlesex, UK.Respiratory Medicines Development Centre, GSK, Stockley Park, Middlesex, UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27445468

Citation

Singh, Dave, et al. "Prevention of Clinically Important Deteriorations in COPD With Umeclidinium/vilanterol." International Journal of Chronic Obstructive Pulmonary Disease, vol. 11, 2016, pp. 1413-24.
Singh D, Maleki-Yazdi MR, Tombs L, et al. Prevention of clinically important deteriorations in COPD with umeclidinium/vilanterol. Int J Chron Obstruct Pulmon Dis. 2016;11:1413-24.
Singh, D., Maleki-Yazdi, M. R., Tombs, L., Iqbal, A., Fahy, W. A., & Naya, I. (2016). Prevention of clinically important deteriorations in COPD with umeclidinium/vilanterol. International Journal of Chronic Obstructive Pulmonary Disease, 11, pp. 1413-24. doi:10.2147/COPD.S101612.
Singh D, et al. Prevention of Clinically Important Deteriorations in COPD With Umeclidinium/vilanterol. Int J Chron Obstruct Pulmon Dis. 2016;11:1413-24. PubMed PMID: 27445468.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prevention of clinically important deteriorations in COPD with umeclidinium/vilanterol. AU - Singh,Dave, AU - Maleki-Yazdi,M Reza, AU - Tombs,Lee, AU - Iqbal,Ahmar, AU - Fahy,William A, AU - Naya,Ian, Y1 - 2016/06/24/ PY - 2016/7/23/entrez PY - 2016/7/23/pubmed PY - 2017/8/9/medline KW - COPD KW - UMEC/VI KW - airway stability KW - deterioration SP - 1413 EP - 24 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 11 N2 - BACKGROUND: Minimizing the risk of disease progression and exacerbations is the key goal of COPD management, as these are well-established indicators of poor COPD prognosis. We developed a novel composite end point assessing three important aspects (lung function, health status, and exacerbations) of worsening in COPD. The objective was to determine whether dual bronchodilation with umeclidinium/vilanterol (UMEC/VI) reduces clinically important deteriorations (CIDs) in COPD versus placebo or bronchodilator monotherapy. METHODS: This study is a post hoc analysis of two 24-week trials comparing UMEC/VI 62.5/25 µg with UMEC 62.5 µg, VI 25 µg, or placebo (Study A; NCT01313650), or UMEC/VI 62.5/25 µg with tiotropium (TIO) 18 µg (Study B; NCT01777334) in patients with symptomatic COPD, without a history of frequent exacerbations. Deterioration was assessed as the time to a first CID, a composite measure defined as a decrease of ≥100 mL in trough forced expiratory volume in 1 second or ≥4-unit increase in St George's Respiratory Questionnaire total score or an on-treatment moderate-to-severe COPD exacerbation. RESULTS: In Study A, fewer patients experienced a first CID with UMEC/VI (44%) versus UMEC (50%), VI (56%), and placebo (75%). The risk of a first CID was reduced with UMEC/VI (hazard ratio [HR]: 0.37 [95% confidence interval, CI: 0.30, 0.45]), UMEC (HR: 0.46 [95% CI: 0.38, 0.56]), and VI (HR: 0.55 [95% CI: 0.45, 0.66]; all P<0.001) versus placebo, and with UMEC/VI versus UMEC (HR: 0.80 [95% CI: 0.65, 0.97]; P<0.05) and versus VI (HR: 0.67 [95% CI: 0.55, 0.81]; P<0.001). In Study B, fewer patients experienced a first CID with UMEC/VI (41%) versus TIO (59%). UMEC/VI reduced the risk of a first composite CID by 43% versus TIO (HR: 0.57 [95% CI: 0.47, 0.69]; P<0.001). CONCLUSION: This exploratory analysis, using a new assessment of clinical deterioration in COPD, revealed that a majority of symptomatic patients with low exacerbation risk experienced a deterioration during the 24-week study periods. UMEC/VI reduces the risk of a first CID versus placebo or bronchodilator monotherapy. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/27445468/Prevention_of_clinically_important_deteriorations_in_COPD_with_umeclidinium/vilanterol_ L2 - https://dx.doi.org/10.2147/COPD.S101612 DB - PRIME DP - Unbound Medicine ER -