Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol

Chad Moretz1, Lindsay GS Bengtson2, Lucie Sharpsten2, Eleena Koep2, Lisa Le2, Junliang Tong2, Richard H Stanford1, Beth Hahn1, Riju Ray1 1Glaxo Smith Kline, Research Triangle Park, Durham, NC, USA; 2Optum, Eden Prairie, MN, USACorrespondence: Chad MoretzGlaxoSmithKline, Research Triangle Park, 5 Moo...

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Main Authors: Moretz C, Bengtson LGS, Sharpsten L, Koep E, Le L, Tong J, Stanford RH, Hahn B, Ray R
Format: Article
Language:English
Published: Dove Medical Press 2019-09-01
Series:International Journal of COPD
Subjects:
Online Access:https://www.dovepress.com/evaluation-of-rescue-medication-use-and-medication-adherence-receiving-peer-reviewed-article-COPD
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author Moretz C
Bengtson LGS
Sharpsten L
Koep E
Le L
Tong J
Stanford RH
Hahn B
Ray R
author_facet Moretz C
Bengtson LGS
Sharpsten L
Koep E
Le L
Tong J
Stanford RH
Hahn B
Ray R
author_sort Moretz C
collection DOAJ
description Chad Moretz1, Lindsay GS Bengtson2, Lucie Sharpsten2, Eleena Koep2, Lisa Le2, Junliang Tong2, Richard H Stanford1, Beth Hahn1, Riju Ray1 1Glaxo Smith Kline, Research Triangle Park, Durham, NC, USA; 2Optum, Eden Prairie, MN, USACorrespondence: Chad MoretzGlaxoSmithKline, Research Triangle Park, 5 Moore Drive, Durham, NC, USATel +1 828 442 6294Email chad.x.moretz@gsk.comBackground: 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.Keywords: COPD, long-acting β2-agonists, long-acting muscarinic antagonists, adherence, rescue medication, real world
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spelling doaj.art-22c75b6b9439405e82cfc0f4e4adda792022-12-22T00:53:21ZengDove Medical PressInternational Journal of COPD1178-20052019-09-01Volume 142047206048344Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterolMoretz CBengtson LGSSharpsten LKoep ELe LTong JStanford RHHahn BRay RChad Moretz1, Lindsay GS Bengtson2, Lucie Sharpsten2, Eleena Koep2, Lisa Le2, Junliang Tong2, Richard H Stanford1, Beth Hahn1, Riju Ray1 1Glaxo Smith Kline, Research Triangle Park, Durham, NC, USA; 2Optum, Eden Prairie, MN, USACorrespondence: Chad MoretzGlaxoSmithKline, Research Triangle Park, 5 Moore Drive, Durham, NC, USATel +1 828 442 6294Email chad.x.moretz@gsk.comBackground: 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.Keywords: COPD, long-acting β2-agonists, long-acting muscarinic antagonists, adherence, rescue medication, real worldhttps://www.dovepress.com/evaluation-of-rescue-medication-use-and-medication-adherence-receiving-peer-reviewed-article-COPDCOPDlong-acting β2-agonistslong-acting muscarinic antagonistsadherencerescue medicationreal world
spellingShingle Moretz C
Bengtson LGS
Sharpsten L
Koep E
Le L
Tong J
Stanford RH
Hahn B
Ray R
Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol
International Journal of COPD
COPD
long-acting β2-agonists
long-acting muscarinic antagonists
adherence
rescue medication
real world
title Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol
title_full Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol
title_fullStr Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol
title_full_unstemmed Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol
title_short Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol
title_sort evaluation of rescue medication use and medication adherence receiving umeclidinium vilanterol versus tiotropium bromide olodaterol
topic COPD
long-acting β2-agonists
long-acting muscarinic antagonists
adherence
rescue medication
real world
url https://www.dovepress.com/evaluation-of-rescue-medication-use-and-medication-adherence-receiving-peer-reviewed-article-COPD
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