慢性阻塞性肺疾病（COPD）患者的每日一次三联疗法：FULFIL 试验的医疗资源利用数据和相关成本。
Once-Daily Triple Therapy in Patients with Advanced COPD: Healthcare Resource Utilization Data and Associated Costs from the FULFIL Trial.
机构信息
Value Evidence and Outcomes, GSK, Research Triangle Park, NC, USA.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
出版信息
Adv Ther. 2017 Sep;34(9):2163-2172. doi: 10.1007/s12325-017-0604-x. Epub 2017 Sep 5.
INTRODUCTION
Chronic obstructive pulmonary disease is associated with a high healthcare resource and cost burden. Healthcare resource utilization was analyzed in patients with symptomatic chronic obstructive pulmonary disease at risk of exacerbations in the FULFIL study. Patients received either once-daily, single inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) 100 µg/62.5 µg/25 µg or twice-daily dual inhaled corticosteroid/long-acting beta agonist therapy (budesonide/formoterol) 400 µg/12 µg.
METHODS
FULFIL was a phase III, randomized, double-blind, double-dummy, multicenter study. Unscheduled contacts with healthcare providers were recorded by patients in a daily electronic diary; the costs of healthcare resource utilization were calculated post hoc using UK reference costs.
RESULTS
Over 24 weeks, slightly fewer patients who received fluticasone furoate/umeclidinium/vilanterol (169/911; 18.6%) required contacts with healthcare providers compared with budesonide/formoterol (180/899; 20.0%). Over 52 weeks in an extension population, fewer patients who received fluticasone furoate/umeclidinium/vilanterol required unscheduled contacts with healthcare providers compared with budesonide/formoterol (25.2% vs. 32.7%). Non-drug costs per treated patient per year were lower in the fluticasone furoate/umeclidinium/vilanterol group than the budesonide/formoterol group over 24 and 52 weeks (£653.80 vs. £763.32 and £749.22 vs. £988.03, respectively), with the total annualized cost over 24 weeks being slightly greater for fluticasone furoate/umeclidinium/vilanterol than budesonide/formoterol (£1,289.35 vs. £1,267.45).
CONCLUSIONS
This healthcare resource utilization evidence suggests that, in a clinical trial setting over a 24- or 52-week timeframe, non-drug costs associated with management of a single inhaler fluticasone furoate/umeclidinium/vilanterol are lower compared with twice-daily budesonide/formoterol.
TRIAL REGISTRATION
ClinicalTrials.gov number: NCT02345161.
FUNDING
GSK.
简介
慢性阻塞性肺疾病与高医疗资源和成本负担有关。在 FULFIL 研究中，对有加重风险的症状性慢性阻塞性肺疾病患者进行了医疗资源利用分析。患者接受每日一次、单一吸入三联疗法（糠酸氟替卡松/乌美溴铵/维兰特罗）100μg/62.5μg/25μg 或每日两次、双吸入皮质类固醇/长效β激动剂疗法（布地奈德/福莫特罗）400μg/12μg。
方法
FULFIL 是一项 III 期、随机、双盲、双模拟、多中心研究。患者每天通过电子日记记录与医疗保健提供者的非计划性接触；事后使用英国参考成本计算医疗资源利用的成本。
结果
在 24 周期间，接受糠酸氟替卡松/乌美溴铵/维兰特罗治疗的患者需要与医疗保健提供者接触的次数略少于布地奈德/福莫特罗治疗的患者（169/911；18.6%比 180/899；20.0%）。在扩展人群中，接受糠酸氟替卡松/乌美溴铵/维兰特罗治疗的患者在 52 周内需要非计划性接触医疗保健提供者的人数少于布地奈德/福莫特罗治疗的患者（25.2%比 32.7%）。在 24 周和 52 周时，氟替卡松糠酸酯/乌美溴铵/维兰特罗组每个治疗患者的非药物年度成本均低于布地奈德/福莫特罗组（653.80 英镑比 763.32 英镑和 749.22 英镑比 988.03 英镑），24 周时氟替卡松糠酸酯/乌美溴铵/维兰特罗组的年度总成本略高于布地奈德/福莫特罗组（1289.35 英镑比 1267.45 英镑）。
结论
在临床试验环境中，在 24 或 52 周的时间内，与每日两次布地奈德/福莫特罗相比，单一吸入氟替卡松糠酸酯/乌美溴铵/维兰特罗管理相关的非药物成本较低。
试验注册
ClinicalTrials.gov 编号：NCT02345161。
资金来源
GSK。
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