Ray J A, Valentine W J, Roze S, Nicklasson L, Cobden D, Raskin P, Garber A, Palmer A J
CORE - Center for Outcomes Research, A unit of IMS, Binningen/Basel, Switzerland.
Diabetes Obes Metab. 2007 Jan;9(1):103-13. doi: 10.1111/j.1463-1326.2006.00581.x.
To project the long-term clinical and economic outcomes of treatment with biphasic insulin aspart 30 (BIAsp 70/30, 30% soluble and 70% protaminated insulin aspart) vs. insulin glargine in insulin-naïve type 2 diabetes patients failing to achieve glycemic control with oral antidiabetic agents alone (OADs).
Baseline patient characteristics and treatment effect data from the recent 'INITIATE' clinical trial served as input to a peer-reviewed, validated Markov/Monte-Carlo simulation model. INITIATE demonstrated improvements in HbA1c favouring BIAsp 70/30 vs. glargine (-0.43%; p < 0.005) and greater efficacy in reaching glycaemic targets among patients poorly controlled on OAD therapy. Effects on life expectancy (LE), quality-adjusted life expectancy (QALE), cumulative incidence of diabetes-related complications and direct medical costs (2004 USD) were projected over 35 years. Clinical outcomes and costs were discounted at a rate of 3.0% per annum. Sensitivity analyses were performed.
Improvements in glycaemic control were projected to lead to gains in LE (0.19 +/- 0.24 years) and QALE (0.19 +/- 0.17 years) favouring BIAsp 70/30 vs. glargine. Treatment with BIAsp 70/30 was also associated with reductions in the cumulative incidences of diabetes-related complications, notably in renal and retinal conditions. The incremental cost-effectiveness ratio was $46 533 per quality-adjusted life year gained with BIAsp 70/30 vs. glargine (for patients with baseline HbA1c >/= 8.5%, it was $34 916). Total lifetime costs were compared to efficacy rates in both arms as a ratio, which revealed that the lifetime cost per patient treated successfully to target HbA1c levels of <7.0% and </= 6.5% were $80 523 and $93 242 lower with BIAsp 70/30 than with glargine, respectively.
Long-term treatment with BIAsp 70/30 was projected to be cost-effective for patients with type 2 diabetes insufficiently controlled on OADs alone compared to glargine. Treatment with BIAsp 70/30 was estimated to represent an appropriate investment of healthcare dollars in the management of type 2 diabetes.
预测在仅使用口服抗糖尿病药物（OADs）未能实现血糖控制的初治2型糖尿病患者中，使用双相门冬胰岛素30（BIAsp 70/30，30%可溶性和70%精蛋白结合门冬胰岛素）与甘精胰岛素治疗的长期临床和经济结局。
近期“INITIATE”临床试验的基线患者特征和治疗效果数据作为输入，用于一个经过同行评审、验证的马尔可夫/蒙特卡洛模拟模型。INITIATE研究显示，与甘精胰岛素相比，BIAsp 70/30组糖化血红蛋白（HbA1c）改善更明显（-0.43%；p<0.005），且在OAD治疗控制不佳的患者中达到血糖目标的疗效更高。预测了35年内对预期寿命（LE）、质量调整预期寿命（QALE）、糖尿病相关并发症的累积发生率和直接医疗成本（2004美元）的影响。临床结局和成本按每年3.0%的贴现率进行贴现。进行了敏感性分析。
预计血糖控制的改善将使LE（0.19±0.24年）和QALE（0.19±0.17年）增加，BIAsp 70/30优于甘精胰岛素。使用BIAsp 70/30治疗还与糖尿病相关并发症的累积发生率降低有关，特别是在肾脏和视网膜疾病方面。BIAsp 70/30与甘精胰岛素相比，每获得一个质量调整生命年的增量成本效益比为46533美元（对于基线HbA1c≥8.5%的患者，为34916美元）。将总终身成本与两组的有效率进行比值比较，结果显示，成功治疗至HbA1c水平<7.0%和≤6.5%的患者，使用BIAsp 70/30的每位患者终身成本分别比使用甘精胰岛素低80523美元和93242美元。
与甘精胰岛素相比，预计对于仅使用OADs控制不佳的2型糖尿病患者，长期使用BIAsp 70/30具有成本效益。估计使用BIAsp 70/30治疗是在2型糖尿病管理中对医疗保健资金的一项合理投资。
