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Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol.
Int J Chron Obstruct Pulmon Dis. 2019; 14:2047-2060.IJ

Abstract

Background

This was the first real-world head-to-head study comparing inhaled long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination treatments as maintenance therapy.

Methods

Retrospective observational study including commercial, Medicare Advantage with Part D or Part D-only enrollees aged ≥40 years from the Optum Research Database. Patients initiated umeclidinium/vilanterol (UMEC/VI) or tiotropium bromide/olodaterol (TIO/OLO) between June 1, 2015 and November 30, 2016 (index date) with 12 months of pre- and post-index continuous enrollment. Outcomes were modeled following the inverse probability of treatment weighting. The primary endpoint, rescue medication use, was modeled using weighted ordinary least squares regression with bootstrapped variance estimation. Intent-to-treat analysis evaluated non-inferiority and superiority of UMEC/VI to TIO/OLO with thresholds of 0.30 and 0 units, respectively. On-treatment sensitivity analysis evaluated the superiority of UMEC/VI to TIO/OLO for rescue medication use. The secondary endpoint, medication adherence (proportion of days covered [PDC]≥80%), was evaluated using weighted logistic regression. Post hoc weighted Cox proportional hazards regression analysis evaluated escalation to multiple inhaler triple therapy (MITT).

Results

The study population included 14,324 patients; 9549 initiated UMEC/VI and 4775 initiated TIO/OLO. During the 12-month post-index period, UMEC/VI initiators used 0.16 fewer adjusted mean units of rescue medication than TIO/OLO initiators (95% CI: -0.28, -0.04), meeting pre-specified non-inferiority (P<0.001) and superiority (P=0.005) criteria; the on-treatment sensitivity analysis for superiority was not statistically significant. Significantly more UMEC/VI than TIO/OLO initiators (28.6% vs 22.7%; P<0.001) achieved a clinically meaningful level (PDC≥80%) of medication adherence. The adjusted risk of escalation to MITT was similar between treatment groups (HR=0.93; 95% CI: 0.81, 1.06; P=0.268).

Conclusion

UMEC/VI was superior to TIO/OLO for rescue medication use and UMEC/VI initiators had better medication adherence than TIO/OLO initiators. This study supports findings from a head-to-head trial that demonstrated significant, clinically meaningful improvements in lung function with UMEC/VI versus TIO/OLO.

Authors+Show Affiliations

Glaxo Smith Kline, Research Triangle Park, Durham, NC, USA.Optum, Eden Prairie, MN, USA.Optum, Eden Prairie, MN, USA.Optum, Eden Prairie, MN, USA.Optum, Eden Prairie, MN, USA.Optum, Eden Prairie, MN, USA.Glaxo Smith Kline, Research Triangle Park, Durham, NC, USA.Glaxo Smith Kline, Research Triangle Park, Durham, NC, USA.Glaxo Smith Kline, Research Triangle Park, Durham, NC, USA.

Pub Type(s)

Comparative Study
Journal Article
Observational Study

Language

eng

PubMed ID

31564852

Citation

Moretz, Chad, et al. "Evaluation of Rescue Medication Use and Medication Adherence Receiving Umeclidinium/vilanterol Versus Tiotropium Bromide/olodaterol." International Journal of Chronic Obstructive Pulmonary Disease, vol. 14, 2019, pp. 2047-2060.
Moretz C, Bengtson LG, Sharpsten L, et al. Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol. Int J Chron Obstruct Pulmon Dis. 2019;14:2047-2060.
Moretz, C., Bengtson, L. G., Sharpsten, L., Koep, E., Le, L., Tong, J., Stanford, R. H., Hahn, B., & Ray, R. (2019). Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol. International Journal of Chronic Obstructive Pulmonary Disease, 14, 2047-2060. https://doi.org/10.2147/COPD.S213520
Moretz C, et al. Evaluation of Rescue Medication Use and Medication Adherence Receiving Umeclidinium/vilanterol Versus Tiotropium Bromide/olodaterol. Int J Chron Obstruct Pulmon Dis. 2019;14:2047-2060. PubMed PMID: 31564852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol. AU - Moretz,Chad, AU - Bengtson,Lindsay Gs, AU - Sharpsten,Lucie, AU - Koep,Eleena, AU - Le,Lisa, AU - Tong,Junliang, AU - Stanford,Richard H, AU - Hahn,Beth, AU - Ray,Riju, Y1 - 2019/09/04/ PY - 2019/04/26/received PY - 2019/08/15/accepted PY - 2019/10/1/entrez PY - 2019/10/1/pubmed PY - 2020/4/14/medline KW - COPD KW - adherence KW - long-acting muscarinic antagonists KW - long-acting β2-agonists KW - real world KW - rescue medication SP - 2047 EP - 2060 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 14 N2 - Background: This was the first real-world head-to-head study comparing inhaled long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination treatments as maintenance therapy. Methods: Retrospective observational study including commercial, Medicare Advantage with Part D or Part D-only enrollees aged ≥40 years from the Optum Research Database. Patients initiated umeclidinium/vilanterol (UMEC/VI) or tiotropium bromide/olodaterol (TIO/OLO) between June 1, 2015 and November 30, 2016 (index date) with 12 months of pre- and post-index continuous enrollment. Outcomes were modeled following the inverse probability of treatment weighting. The primary endpoint, rescue medication use, was modeled using weighted ordinary least squares regression with bootstrapped variance estimation. Intent-to-treat analysis evaluated non-inferiority and superiority of UMEC/VI to TIO/OLO with thresholds of 0.30 and 0 units, respectively. On-treatment sensitivity analysis evaluated the superiority of UMEC/VI to TIO/OLO for rescue medication use. The secondary endpoint, medication adherence (proportion of days covered [PDC]≥80%), was evaluated using weighted logistic regression. Post hoc weighted Cox proportional hazards regression analysis evaluated escalation to multiple inhaler triple therapy (MITT). Results: The study population included 14,324 patients; 9549 initiated UMEC/VI and 4775 initiated TIO/OLO. During the 12-month post-index period, UMEC/VI initiators used 0.16 fewer adjusted mean units of rescue medication than TIO/OLO initiators (95% CI: -0.28, -0.04), meeting pre-specified non-inferiority (P<0.001) and superiority (P=0.005) criteria; the on-treatment sensitivity analysis for superiority was not statistically significant. Significantly more UMEC/VI than TIO/OLO initiators (28.6% vs 22.7%; P<0.001) achieved a clinically meaningful level (PDC≥80%) of medication adherence. The adjusted risk of escalation to MITT was similar between treatment groups (HR=0.93; 95% CI: 0.81, 1.06; P=0.268). Conclusion: UMEC/VI was superior to TIO/OLO for rescue medication use and UMEC/VI initiators had better medication adherence than TIO/OLO initiators. This study supports findings from a head-to-head trial that demonstrated significant, clinically meaningful improvements in lung function with UMEC/VI versus TIO/OLO. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/31564852/Evaluation_of_rescue_medication_use_and_medication_adherence_receiving_umeclidinium/vilanterol_versus_tiotropium_bromide/olodaterol_ L2 - https://dx.doi.org/10.2147/COPD.S213520 DB - PRIME DP - Unbound Medicine ER -