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Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study.

Abstract

INTRODUCTION

Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO).

METHODS

In this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV1]: 50%-70% of predicted; modified Medical Research Council [mMRC] score ≥1) and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV1 at Day 85 (primary end point), 0-3 h serial FEV1, rescue medication use, Transition Dyspnea Index (TDI), St George's Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Safety evaluations included adverse events (AEs).

RESULTS

Compared with TIO, UMEC/VI produced greater improvements in trough FEV1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45-131]; P<0.001) and FEV1 after 5 min on Day 1 (50 mL [95% CI: 27-72]; P<0.001). Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: -0.1 puffs/d [95% CI: -0.2-0.0]; P≤0.05). More patients achieved clinically meaningful improvements in TDI score (≥1 unit) with UMEC/VI (63%) versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21-2.64]; P≤0.01). Improvements in SGRQ and CAT scores were similar between treatments. The incidence of AEs was similar with UMEC/VI (30%) and TIO (31%).

CONCLUSION

UMEC/VI step-up therapy provides clinical benefit over TIO monotherapy in patients with moderate COPD who are symptomatic on TIO alone.

Authors+Show Affiliations

Clinical Research Institute of Southern Oregon, Medford, OR.Respiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA.Respiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA.Clinical Statistics, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex.Respiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA.Respiratory Department, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.Respiratory Department, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28280319

Citation

Kerwin, Edward M., et al. "Umeclidinium/vilanterol as Step-up Therapy From Tiotropium in Patients With Moderate COPD: a Randomized, Parallel-group, 12-week Study." International Journal of Chronic Obstructive Pulmonary Disease, vol. 12, 2017, pp. 745-755.
Kerwin EM, Kalberg CJ, Galkin DV, et al. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study. Int J Chron Obstruct Pulmon Dis. 2017;12:745-755.
Kerwin, E. M., Kalberg, C. J., Galkin, D. V., Zhu, C. Q., Church, A., Riley, J. H., & Fahy, W. A. (2017). Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study. International Journal of Chronic Obstructive Pulmonary Disease, 12, pp. 745-755. doi:10.2147/COPD.S119032.
Kerwin EM, et al. Umeclidinium/vilanterol as Step-up Therapy From Tiotropium in Patients With Moderate COPD: a Randomized, Parallel-group, 12-week Study. Int J Chron Obstruct Pulmon Dis. 2017;12:745-755. PubMed PMID: 28280319.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study. AU - Kerwin,Edward M, AU - Kalberg,Chris J, AU - Galkin,Dmitry V, AU - Zhu,Chang-Qing, AU - Church,Alison, AU - Riley,John H, AU - Fahy,William A, Y1 - 2017/02/24/ PY - 2017/3/11/entrez PY - 2017/3/11/pubmed PY - 2017/10/11/medline KW - COPD KW - LABA KW - LAMA KW - step-up KW - tiotropium KW - umeclidinium/vilanterol SP - 745 EP - 755 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 12 N2 - INTRODUCTION: Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO). METHODS: In this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV1]: 50%-70% of predicted; modified Medical Research Council [mMRC] score ≥1) and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV1 at Day 85 (primary end point), 0-3 h serial FEV1, rescue medication use, Transition Dyspnea Index (TDI), St George's Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Safety evaluations included adverse events (AEs). RESULTS: Compared with TIO, UMEC/VI produced greater improvements in trough FEV1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45-131]; P<0.001) and FEV1 after 5 min on Day 1 (50 mL [95% CI: 27-72]; P<0.001). Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: -0.1 puffs/d [95% CI: -0.2-0.0]; P≤0.05). More patients achieved clinically meaningful improvements in TDI score (≥1 unit) with UMEC/VI (63%) versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21-2.64]; P≤0.01). Improvements in SGRQ and CAT scores were similar between treatments. The incidence of AEs was similar with UMEC/VI (30%) and TIO (31%). CONCLUSION: UMEC/VI step-up therapy provides clinical benefit over TIO monotherapy in patients with moderate COPD who are symptomatic on TIO alone. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/28280319/Umeclidinium/vilanterol_as_step_up_therapy_from_tiotropium_in_patients_with_moderate_COPD:_a_randomized_parallel_group_12_week_study_ L2 - https://dx.doi.org/10.2147/COPD.S119032 DB - PRIME DP - Unbound Medicine ER -