Palmer Andrew J, Roze Stéphane, Valentine William J, Smith Inger, Wittrup-Jensen Kim U
Center for Outcomes Research, Binningen/Basel, Switzerland.
Curr Med Res Opin. 2004 Nov;20(11):1729-46. doi: 10.1185/030079904X5661.
A meta-analysis of results from four clinical trials in type 1 diabetes patients showed that insulin detemir (IDet)-based basal/bolus treatment of type 1 diabetes led to improved HbA1c (0.15%-points lower), reduced risk of major hypoglycaemic events (by 2%) and reduction in body mass index (BMI) (0.26 kg/m2) compared to protamine Hagedorn human (NPH) insulin-based basal/bolus therapy in type 1 patients.
A published, validated, peer-reviewed Markov simulation model (the CORE Diabetes Model) projected short-term results obtained from the fixed-effects (weighted average) meta-analysis to long-term incidence of complications, improvements in quality-adjusted life years (QALY), long-term costs and the cost-effectiveness for IDet combinations versus NPH combinations in type 1 diabetes patients. Probabilities of complications and HbA1c-dependent adjustments were derived from the DCCT and other studies. Costs of treating complications in the UK were retrieved from published sources. Total direct costs (complications + treatment costs) for each arm were projected over patient lifetimes from a UK National Heath Service perspective. Both costs and clinical outcomes were discounted at 3.5% annually.
Improved glycaemic control, decreased hypoglycaemic events and BMI with IDet-based basal/bolus therapy led to fewer diabetes-related complications, an increase in quality-adjusted life expectancy of 0.09 years, increased total lifetime costs/patient of 1707 pounds sterling and an incremental cost-effectiveness ratio of 19,285 pounds sterling per QALY gained. Results were stable under a wide range of reasonable assumptions.
Short-term improvements seen with IDet combinations versus NPH combinations led to decreased complications, improvements in QALYs and reductions in complication costs, which partially offset the additional costs of detemir, leading to a cost-effectiveness ratio which fell within a range considered to represent excellent value for money (< 35,000 pounds sterling/QALY gained).
一项对1型糖尿病患者四项临床试验结果的荟萃分析表明,与基于精蛋白锌胰岛素(NPH)的基础/餐时胰岛素治疗相比,基于地特胰岛素(IDet)的1型糖尿病基础/餐时治疗可使糖化血红蛋白(HbA1c)改善(降低0.15个百分点),严重低血糖事件风险降低(2%),体重指数(BMI)降低(0.26kg/m²)。
一个已发表、经过验证且经同行评审的马尔可夫模拟模型(CORE糖尿病模型)将固定效应(加权平均)荟萃分析得出的短期结果预测为1型糖尿病患者并发症的长期发生率、质量调整生命年(QALY)的改善、长期成本以及IDet组合与NPH组合的成本效益。并发症概率和依赖HbA1c的调整数据来自糖尿病控制与并发症试验(DCCT)及其他研究。英国治疗并发症的成本从已发表的资料中获取。从英国国家医疗服务体系的角度预测了各治疗组患者一生的总直接成本(并发症+治疗成本)。成本和临床结果均按每年3.5%进行贴现。
基于IDet的基础/餐时治疗改善了血糖控制,降低了低血糖事件及BMI,从而减少了糖尿病相关并发症,质量调整预期寿命增加了0.09年;患者一生的总费用增加了1707英镑,每获得一个QALY的增量成本效益比为19285英镑。在广泛的合理假设下,结果是稳定的。
与NPH组合相比,IDet组合的短期改善导致并发症减少、QALY改善以及并发症成本降低,这部分抵消了地特胰岛素的额外成本,从而使成本效益比处于被认为代表性价比极高的范围内(每获得一个QALY<35000英镑)。