Price D, Wirén A, Kuna P
Department of General Practice and Primary Care, University of Aberdeen, Aberdeen AB25 2AY, UK.
Allergy. 2007 Oct;62(10):1189-98. doi: 10.1111/j.1398-9995.2007.01466.x.
Budesonide/formoterol (Symbicort) Maintenance and Reliever Therapy (SMART) is an effective asthma-management approach that treats symptoms with rapid increases in budesonide/formoterol. The cost-effectiveness of SMART vs higher fixed-dose budesonide/formoterol or salmeterol/fluticasone is unknown.
This 6-month, double-blind study randomized patients with asthma uncontrolled by inhaled corticosteroids alone (n = 3335; age > or =12 years) to budesonide/formoterol 160/4.5 microg b.i.d. plus additional doses as needed (SMART), budesonide/formoterol 320/9 microg b.i.d. plus as-needed terbutaline, or salmeterol/fluticasone 50/250 microg b.i.d. plus as-needed terbutaline. Economic analysis, assuming health care and societal perspectives, applied 2004 UK and Australian unit costs to pooled resource-use data. The effectiveness variable was the rate of severe exacerbations/patient/6 months.
Patients treated using the SMART approach experienced fewer severe exacerbations than fixed-dose budesonide/formoterol and salmeterol/fluticasone patients (0.12 vs 0.16 and 0.19 events/patient/6 months, respectively; P < or = 0.0048). Budesonide/formoterol (Symbicort) Maintenance and Reliever Therapy provided similar improvements in other markers of asthma control at a lower overall daily inhaled corticosteroid dose compared with fixed-dose treatment. Study drug costs accounted for a majority of both direct costs (DC; 78-87%) and total costs (TC; 50-63%) for all treatments, and were significantly lower in the SMART group compared with the fixed-dose groups (P < or = 0.0014). Direct and TC per patient/6 months were lower for SMART vs salmeterol/fluticasone (DC:-AUS$154, P < 0.0001; TC:-AUS$163, P = 0.0036;-87 pound sterling, P = 0.0026) and vs budesonide/formoterol using UK costs (DC:-73 pounds sterling, P < 0.0001; TC:- 91 pounds sterling, P = 0.0014). Costs tended to be lower for SMART vs budesonide/formoterol using Australian costs (DC:-AUS$35, P = 0.16; TC:-AUS$70, P = 0.20). Results were stable under sensitivity testing. Indirect resource use and cost were not significantly different between groups.
Compared with higher fixed-dose budesonide/formoterol and salmeterol/fluticasone, SMART reduces the incidence of severe exacerbations at a lower or similar overall cost and can be considered a cost-effective treatment regimen.
布地奈德/福莫特罗（信必可）维持与缓解治疗（SMART）是一种有效的哮喘管理方法，通过迅速增加布地奈德/福莫特罗的剂量来治疗症状。SMART与高固定剂量布地奈德/福莫特罗或沙美特罗/氟替卡松相比的成本效益尚不清楚。
这项为期6个月的双盲研究将单独使用吸入性糖皮质激素无法控制哮喘的患者（n = 3335；年龄≥12岁）随机分为布地奈德/福莫特罗160/4.5微克，每日两次，必要时增加额外剂量（SMART）组、布地奈德/福莫特罗320/9微克，每日两次加必要时使用特布他林组或沙美特罗/氟替卡松50/250微克，每日两次加必要时使用特布他林组。从医疗保健和社会角度进行的经济分析，将2004年英国和澳大利亚的单位成本应用于汇总的资源使用数据。有效性变量为严重加重发作率/患者/6个月。
采用SMART方法治疗的患者比固定剂量布地奈德/福莫特罗和沙美特罗/氟替卡松治疗的患者经历的严重加重发作更少（分别为0.12次与0.16次和0.19次事件/患者/6个月；P≤0.0048）。与固定剂量治疗相比，布地奈德/福莫特罗（信必可）维持与缓解治疗在总体每日吸入性糖皮质激素剂量较低的情况下，在哮喘控制的其他指标方面提供了类似的改善。研究药物成本占所有治疗直接成本（DC；78 - 87%）和总成本（TC；50 - 63%）的大部分，SMART组与固定剂量组相比显著更低（P≤0.0014）。与沙美特罗/氟替卡松相比，SMART组每位患者/6个月的直接成本和总成本更低（DC：-154澳元，P < 0.0001；TC：-163澳元，P = 0.0036；-87英镑-P = 0.0026），与使用英国成本的布地奈德/福莫特罗相比也更低（DC：-73英镑，P < 0.0001；TC：-91英镑，P = 0.0014）。使用澳大利亚成本时，与布地奈德/福莫特罗相比，SMART组成本倾向于更低（DC：-35澳元，P = 0.16；TC：-70澳元，P = 0.20）。敏感性测试结果稳定。各组间间接资源使用和成本无显著差异。
与高固定剂量布地奈德/福莫特罗和沙美特罗/氟替卡松相比，SMART以更低或相似的总体成本降低了严重加重发作的发生率，可被视为一种具有成本效益的治疗方案。
