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

Abstract

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.

Time-to-first exacerbation, adherence, and medical costs among US patients receiving umeclidinium/vilanterol or tiotropium as initial maintenance therapy for chronic obstructive pulmonary disease: a retrospective cohort study

“…In the current study, both mean PDC and the proportion of patients achieving a clinically relevant level of adherence (PDC ≥ 80%) were significantly higher in patients treated with UMEC/VI than among those treated with TIO; however, no significant differences in moderate and severe exacerbations were detected between cohorts, possibly due to the low incidence of post-index exacerbations observed in the study population. These data complement previous findings of improved adherence among patients treated with UMEC/VI versus other combination treatments including budesonide/formoterol [ 17 ], tiotropium/olodaterol [ 18 ], and fluticasone propionate/salmeterol [ 19 ]. Reasons for better adherence to UMEC/VI compared with TIO were not evaluated in the current study; however, previous research has shown that a number of factors can contribute to adherence rates, including patients’ characteristics or views regarding the treatment of their disease, complexity of the treatment regimen, and the inhaler device [ 20 – 22 ].…”

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

“…Another head-to-head study had shown that IND/GLY and UME/VIL provided clinically meaningful and comparable bronchodilation [ 34 ]. Compared with rescue and adherence medication, UMEC/VI was superior to TIO/OLO for rescue medication use, and UMEC/VI initiators had better medication adherence [ 35 ]. For cost-effectiveness, TIO/OLO showed a cost-effective option for the maintenance treatment of adults with chronic obstructive pulmonary disease in the UK than the other two dual bronchodilators [ 36 ].…”

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

“…These three LAMA/LABA FDCs were previously found to have similar incremental cost-effectiveness ratios [ 16 ], efficacy, and safety [ 17 ]. 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 ].…”