Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis

Navarrete, Bernardino Alcázar; Boucot, I.; Naya, Ian; Tombs, Lee; Lipson, David A.; Compton, Chris; Feldman, Gregory

doi:10.1007/s41030-018-0057-7

Cited by 13 publications

(9 citation statements)

References 36 publications

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“…However, the superiority criteria were not met in the on-treatment sensitivity analysis, despite a similar treatment difference in both analyses (0.16 vs 0.18 rescue medication units PPPY in the ITT vs sensitivity analyses). The results of this real-world study corroborate the findings of a recent head-to-head RCT, which demonstrated a significant reduction in rescue medication use as well as improvements in lung function with UMEC/VI compared with TIO/OLO over an 8-week period in both the ITT population7 and in a maintenance-naïve subgroup 8…”

Section: Discussionsupporting

confidence: 84%

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

Moretz¹,

Bengtson²,

Sharpsten³

et al. 2019

COPD

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Background This was the first real-world head-to-head study comparing inhaled long-acting muscarinic antagonist/long-acting β 2 -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.

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Section: Discussionsupporting

confidence: 84%

“…Patients receiving UMEC/VI also reported significantly less rescue medication use compared with those receiving TIO/OLO 7. In addition, a post hoc analysis of the maintenance-naïve subgroup from the same study also showed greater improvements in lung function and reduced rescue medication use with UMEC/VI compared with TIO/OLO 8…”

Section: Introductionmentioning

confidence: 87%

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

Moretz¹,

Bengtson²,

Sharpsten³

et al. 2019

COPD

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“…Previous studies have also been head-to-head compared the effectiveness of different bronchodilators in COPD patients. Feldmen and colleagues had reported that superiority was observed for the primary endpoint of trough FEV1 at week 8 with UME/VIL compared with TIO/OLO in patients with symptomatic COPD [ 32 , 33 ]. There are some differences in our study compared with Feldmen’s study.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Effectiveness Using Different Dual Bronchodilator Agents in Chronic Obstructive Pulmonary Disease Treatment

Cheng

2021

JCM

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The effectiveness and safety of fixed dual long-acting bronchodilators for chronic obstructive pulmonary disease (COPD) patients have been well established; however, there is a paucity of clinical effectiveness comparison in patients with COPD treatment. The aim of the current study was to compare the effectiveness of three once-daily dual bronchodilator agents in patients with COPD. Patients with diagnosed COPD and treated with a long-acting beta-agonist (LABA) + long-acting muscarinic antagonist (LAMA) fixed-dose combination therapy (UME/VIL (umeclidinium and vilanterol inhalation powder), IND/GLY (indacaterol and glycopyrronium), and TIO/OLO (tiotropium and olodaterol)) were enrolled in this retrospective study over a period of 12 months. Effectiveness assessments were evaluated using a COPD assessment test (CAT) and lung function parameters. Besides, times for acute exacerbation were also assessed. The enrolled patients’ number was 177 in IND/GLY, 176 in UME/VIL and 183 in TIO/OLO. Lung function measurements with FEV1 had significantly improved for patients using TIO/OLO (98.7 mL) compared to those of IND/GLY (65.2 mL) and UME/VIL (64.4 mL) (p < 0.001). CAT scores were also significantly decreased in patients treated with TIO/OLO (CAT down 5.6) than those with IND/GLY (3.8) and UME/VIL (3.9) (p = 0.03). Acute exacerbation was also reduced in patients using TIO/OLO (4.9%) compared with those using IND/GLY (10.2%) and UME/VIL (11.9%) (p = 0.01). Significant improvement in pulmonary function, symptoms were demonstrated after 12 months of LABA/LAMA fixed-dose combination therapy with three different treatment options. TIO/OLO demonstrated higher therapeutic effects compared with UME/VIL or IND/GLY. Determining clinical relevance will require a well-designed randomized controlled trial.

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“…In a comparison of two medications, Ume/Vil was reported to be superior to Tio/Olo in rescue medication use and medication adherence [ 18 ], and was also reported to show better cost-effectiveness (compared to Tio/Olo) [ 19 ]. In a direct comparison test, Ume/Vil was superior to Tio/Olo regarding the change of trough FEV1 [ 14 , 15 ]. However, taken together, the published reports appear to be contradictory.…”

Section: Discussionmentioning

confidence: 99%

“…Only Gly/Ind, Ume/Vil, and Tio/Olo are administered once daily. Although an indirect comparison of these three medications has previously been reported [ 13 ], direct comparisons between any two of these medications are limited [ 14 , 15 ], and no direct controlled study of three once-daily FDC medications has been reported. Therefore, a direct controlled comparison study with Gly/Ind, Ume/Vil, and Tio/Olo was conducted, and the effectiveness, preference, and safety of these three medications were compared and investigated.…”

Section: Introductionmentioning

confidence: 99%

A randomized controlled trial of long-acting muscarinic antagonist and long-acting β2 agonist fixed-dose combinations in patients with chronic obstructive pulmonary disease

et al. 2021

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Background In chronic obstructive pulmonary disease (COPD) patients, combination treatment with long-acting muscarinic antagonist (LAMA) and long-acting β2 agonist (LABA) increases forced expiratory volume in one second and reduces symptoms compared to monotherapy. In Japan, three different once-daily fixed-dose combinations (FDCs) have been prescribed since 2015, although a direct comparison of these FDCs has never been performed. The objective of the present study was to compare the effectiveness, preference, and safety of three LAMA/LABA FDCs—glycopyrronium/indacaterol (Gly/Ind), umeclidinium/vilanterol (Ume/Vil), and tiotropium/olodaterol (Tio/Olo)—in patients with COPD. Methods We enrolled 75 COPD outpatients (male:female ratio, 69:6; 77.4 ± 6.9 years). A prospective, randomized, crossover study was conducted on three groups using three FDCs: Gly/Ind; Ume/Vil; and Tio/Olo. Each medication was administered for 4 weeks before crossover (total 12 weeks). After each FDC administration, a respiratory function test and questionnaire survey were conducted. A comparative questionnaire survey of all three LAMA/LABA FDCs was conducted after 12 weeks (following administration of final FDC). Results No significant differences in COPD Assessment Test or modified Medical Research Council dyspnea questionnaire were reported in the surveys completed after each FDC administration; no significant differences in spirometric items were observed. In the final comparative questionnaire survey, patients reported better actual feeling of being able to inhale following Gly/Ind administration compared with Tio/Olo, although no significant differences in adverse events or other evaluations were reported. Conclusions The three LAMA/LABA FDCs administered to COPD patients show similar effects and safety, although some minor individual preference was reported. Trial registration This study retrospectively registered with the University Hospital Medical Information Network Clinical Trials Registry (number UMIN000041342, registered on August 6, 2020).

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Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis

Cited by 13 publications

References 36 publications

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

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

Comparison of Effectiveness Using Different Dual Bronchodilator Agents in Chronic Obstructive Pulmonary Disease Treatment

A randomized controlled trial of long-acting muscarinic antagonist and long-acting β2 agonist fixed-dose combinations in patients with chronic obstructive pulmonary disease

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