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Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials.
Adv Ther 2017; 33(12):2188-2199AT

Abstract

INTRODUCTION

Dual bronchodilator therapy is reserved as a second-line treatment in patients with chronic obstructive pulmonary disease (COPD) and provides benefits in lung function and health status versus monotherapy. The aim of this study was to determine whether early initiation of a dual bronchodilator versus monotherapy reduced the risk of deterioration in COPD.

METHODS

This post hoc pooled analysis investigated the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg/day compared with tiotropium (TIO) 18 mcg/day in a maintenance-naïve (MN) subgroup of patients relative to the intent-to-treat (ITT) population from three 6-month active comparator studies (n = 1747). Other treatment arms (UMEC/VI 125/25, VI 25 and UMEC 125) comprised 850 patients in total but were not included in this analysis. The primary endpoint was trough forced expiratory volume in 1 s (FEV1). St George's Respiratory Questionnaire (SGRQ) score, rescue medication use, and a novel composite endpoint of short-term clinically important deterioration (CID; ≥100 ml decrease in trough FEV1, ≥4-unit increase in SGRQ score, or a COPD exacerbation) were also assessed.

RESULTS

UMEC/VI improved trough FEV1 versus TIO at day 169 [least squares mean (95% confidence interval): MN: 146 ml (102-189) and ITT: 95 ml (71-118); both P < 0.001]. Both UMEC/VI and TIO improved SGRQ and rescue use in the two populations, with greater improvements in rescue use with UMEC/VI versus TIO. UMEC/VI reduced the risk of short-term clinically important deterioration versus TIO [hazard ratio; 95% confidence interval: MN: 0.66 (0.51-0.85); ITT: 0.62 (0.54-0.71), both P ≤ 0.001]. Adverse events were similar across both populations and treatments.

CONCLUSIONS

Early use of dual-bronchodilator therapy has superior efficacy on lung function and may reduce the risk of short-term deterioration compared to monotherapy in symptomatic patients with COPD.

CLINICAL TRIAL REGISTRATION

GSK analysis 202066 (NCT01316900/DB2113360, NCT01316913/DB2113374, NCT01777334/ZEP117115).

FUNDING

This study was funded by GSK.

Authors+Show Affiliations

Division of Respiratory Medicine, Women's College Hospital, University of Toronto, Toronto, ON, Canada. maleki.pccrc@on.aibn.com.Medicines Evaluation Unit, University of Manchester, University Hospital of South Manchester Foundation Trust, Manchester, UK.South Texas Veterans Health Care System, Audie L. Murphy Hospital, and University of Texas Health Science Center, San Antonio, TX, USA.Precise Approach LTD, Birmingham, UK.GSK, Respiratory Medicines Development Centre, Stockley Park, Middlesex, UK.GSK, Respiratory Medicines Development Centre, Stockley Park, Middlesex, UK.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27796912

Citation

Maleki-Yazdi, M Reza, et al. "Assessing Short-term Deterioration in Maintenance-naïve Patients With COPD Receiving Umeclidinium/Vilanterol and Tiotropium: a Pooled Analysis of Three Randomized Trials." Advances in Therapy, vol. 33, no. 12, 2017, pp. 2188-2199.
Maleki-Yazdi MR, Singh D, Anzueto A, et al. Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017;33(12):2188-2199.
Maleki-Yazdi, M. R., Singh, D., Anzueto, A., Tombs, L., Fahy, W. A., & Naya, I. (2017). Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Advances in Therapy, 33(12), pp. 2188-2199.
Maleki-Yazdi MR, et al. Assessing Short-term Deterioration in Maintenance-naïve Patients With COPD Receiving Umeclidinium/Vilanterol and Tiotropium: a Pooled Analysis of Three Randomized Trials. Adv Ther. 2017;33(12):2188-2199. PubMed PMID: 27796912.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Assessing Short-term Deterioration in Maintenance-naïve Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. AU - Maleki-Yazdi,M Reza, AU - Singh,Dave, AU - Anzueto,Antonio, AU - Tombs,Lee, AU - Fahy,William A, AU - Naya,Ian, Y1 - 2016/10/28/ PY - 2016/08/25/received PY - 2016/11/1/pubmed PY - 2017/8/29/medline PY - 2016/11/1/entrez KW - Chronic obstructive pulmonary disease KW - Clinically important deterioration KW - Respiratory KW - Umeclidinium KW - Vilanterol SP - 2188 EP - 2199 JF - Advances in therapy JO - Adv Ther VL - 33 IS - 12 N2 - INTRODUCTION: Dual bronchodilator therapy is reserved as a second-line treatment in patients with chronic obstructive pulmonary disease (COPD) and provides benefits in lung function and health status versus monotherapy. The aim of this study was to determine whether early initiation of a dual bronchodilator versus monotherapy reduced the risk of deterioration in COPD. METHODS: This post hoc pooled analysis investigated the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg/day compared with tiotropium (TIO) 18 mcg/day in a maintenance-naïve (MN) subgroup of patients relative to the intent-to-treat (ITT) population from three 6-month active comparator studies (n = 1747). Other treatment arms (UMEC/VI 125/25, VI 25 and UMEC 125) comprised 850 patients in total but were not included in this analysis. The primary endpoint was trough forced expiratory volume in 1 s (FEV1). St George's Respiratory Questionnaire (SGRQ) score, rescue medication use, and a novel composite endpoint of short-term clinically important deterioration (CID; ≥100 ml decrease in trough FEV1, ≥4-unit increase in SGRQ score, or a COPD exacerbation) were also assessed. RESULTS: UMEC/VI improved trough FEV1 versus TIO at day 169 [least squares mean (95% confidence interval): MN: 146 ml (102-189) and ITT: 95 ml (71-118); both P < 0.001]. Both UMEC/VI and TIO improved SGRQ and rescue use in the two populations, with greater improvements in rescue use with UMEC/VI versus TIO. UMEC/VI reduced the risk of short-term clinically important deterioration versus TIO [hazard ratio; 95% confidence interval: MN: 0.66 (0.51-0.85); ITT: 0.62 (0.54-0.71), both P ≤ 0.001]. Adverse events were similar across both populations and treatments. CONCLUSIONS: Early use of dual-bronchodilator therapy has superior efficacy on lung function and may reduce the risk of short-term deterioration compared to monotherapy in symptomatic patients with COPD. CLINICAL TRIAL REGISTRATION: GSK analysis 202066 (NCT01316900/DB2113360, NCT01316913/DB2113374, NCT01777334/ZEP117115). FUNDING: This study was funded by GSK. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/27796912/Assessing_Short_term_Deterioration_in_Maintenance_naïve_Patients_with_COPD_Receiving_Umeclidinium/Vilanterol_and_Tiotropium:_A_Pooled_Analysis_of_Three_Randomized_Trials_ L2 - https://dx.doi.org/10.1007/s12325-016-0430-6 DB - PRIME DP - Unbound Medicine ER -