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口服降糖药治疗失败的2型糖尿病患者的胰岛素治疗:门冬胰岛素70/30与甘精胰岛素在美国的成本效益比较

Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US.

作者信息

Ray J A, Valentine W J, Roze S, Nicklasson L, Cobden D, Raskin P, Garber A, Palmer A J

机构信息

CORE - Center for Outcomes Research, A unit of IMS, Binningen/Basel, Switzerland.

出版信息

Diabetes Obes Metab. 2007 Jan;9(1):103-13. doi: 10.1111/j.1463-1326.2006.00581.x.

Abstract

OBJECTIVES

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).

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

方法

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。

结果

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。

结论

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。

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