Effectiveness of Umeclidinium-Vilanterol for Protocolized Management of Chronic Obstructive Pulmonary Disease Exacerbation in Hospitalized Patients: A Sequential Period Analysis

Abstract

Background: Bronchodilator therapy is a foundation of chronic obstructive pulmonary disease (COPD) exacerbation treatment. Although international guidelines recommend short-acting formulations given multiple times per day, long-acting formulations have not been adequately evaluated. The objective of our study was to determine the effectiveness of umeclidinium-vilanterol (UME/VIL), long-acting beta2-agonist/long-acting muscarinic antagonist (LABA/LAMA) as a once-daily alternative for treating COPD exacerbations in hospitalized patients. Methods: In this retrospective sequential period analysis, we reviewed electronic medical records of patients hospitalized for COPD exacerbations before (September 1, 2015 to February 29, 2016) and after (April 1, 2016 to September 30, 2016) incorporation of UME/VIL into our standard COPD protocol. Before implementation, patients received a daily anticholinergic plus twice-daily long-acting beta2-agonist therapy (tiotropium plus formoterol, n=65). After implementation, UME/VIL replaced the previous regimen (n=58). No other changes were made to the COPD protocol. The primary outcome was 30-day hospital readmission rate. Hospital length of stay, 30-day mortality, and cost of care were analyzed as secondary outcomes. Results: A trend toward increased 30-day readmission rates in the post-intervention group (24.1% versus 10.8%, p=0.049) was no longer statistically significant after adjustment for severity of illness (based on case-mix index) and complications or comorbidities based on diagnosis-related group codes (adjusted odds ratio: 2.499; 95% confidence interval: 0.916-7.380; p=0.074). Conclusion: After adjustment for potential confounders, the implementation of a LABA/LAMA combination product was not statistically associated with an increased 30-day readmission rate but was associated with lower cost of care. AbstractAbbreviations: chronic obstructive pulmonary disease, COPD; umeclidinium/vilanterol, UME/VIL; long-acting beta2-agonist/long-acting muscarinic antagonist, LABA/LAMA; pulmonary function test, PFT; forced expiratory volume in 1 second, FEV 1 ; forced vital capacity, FVC; Global initiative for chronic Obstructive Lung Disease, GOLD; electronic medical record, EMR; Medicare severity diagnosis-related groups, MS-DRG; case-mix index, CMI; Center for Disease Control, CDC; International Classification of Disease(s), ICD; standard deviation, SD Funding Support: None Date of Acceptance: October 24, 2017 Citation: Chapin TW, Mann MA, Brown GL, Leitheiser TL, Anderson B, Leedahl DD. Effectiveness of umeclidinium-vilanterol for protocolized management of chronic obstructive pulmonary disease exacerbation in hospitalized patients: A sequential period analysis.

<p>Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD</p>

“…The monthly severe exacerbation risk was also higher in those patients who had not yet started UMEC/VI (HR=1.74, 95% CI, 1.35–2.23, P <0.001) during the 12-month study period 53. A single-center, retrospective, sequential, period analysis study of patients with COPD between 1 September 2015 and 29 February 2016 and 1 April 2016 to 30 September 2016 evaluated the incorporation of UMEC/VI into a standard COPD treatment protocol for hospitalized patients 54. A trend toward reduced readmission rates was seen after adding UMEC/VI (24.1% versus 10.8%) to the standard protocol but this was based on small patient numbers (pre-65 and post-58).…”