Glycemic Control With Insulin Glargine Plus Insulin Glulisine Versus Premixed Insulin Analogues in Real-World Practices: A Cost-Effectiveness Study With a Randomized Pragmatic Trial Design

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• 作者：Philip A. Levin MD¹ ; ^{pal3420@yahoo.com" rel="nofollow} ; Quanwu Zhang PhD² ; James H. Mersey MD¹ ; Francis Y. Lee MD¹ ; Lee A. Bromberger BS ; CCRP¹ ; Madhu Bhushan LCSW³ ; Rajat Bhushan MD³
• 关键词：cost-effectiveness ; insulin glargine ; insulin glulisine ; premixed insulin ; type 2 diabetes
• 刊名：Clinical Therapeutics
• 出版年：2011
• 出版时间：July 2011
• 年：2011
• 卷：33
• 期：7
• 页码：841-850
• 全文大小：308 K

文摘

Background

Cost can be an important consideration, along with safety and efficacy, in deciding the most appropriate treatment for patients with type 2 diabetes. Both basal-bolus and premixed insulin analogue regimens are widely used in clinical practice; however, limited information is available regarding cost-effectiveness.

Objective

The goal of this study was to compare glycemic control, cost-effectiveness, and quality of life effects of insulin glargine plus insulin glulisine (glargine/glulisine) versus premixed insulin analogues in real-world clinical practice.

Methods

Adults with type 2 diabetes (glycosylated hemoglobin [HbA_1c] ≥7.0%) at 3 US endocrinology centers were randomly assigned to receive either glargine/glulisine or premixed insulin analogues and continued treatment following the centers' usual practice. HbA_1c, weight, insulin dose, concomitant oral antidiabetic drug (OAD) usage, and hypoglycemia were evaluated at baseline and 3, 6, and 9 months. Medication costs, including costs for all insulin or OAD regimens, were estimated using published wholesale acquisition costs.

Results

A total of 197 patients were randomized to receive glargine/glulisine therapy (n = 106) or premixed analogue therapy (n = 91). Overall, the mean age was 56 years, the mean duration of diabetes was 13 years, with a mean HbA_1c of 9.25% and mean BMI of 35.8 kg/m² at baseline. Patients randomized to receive glargine/glulisine had a greater mean HbA_1c reduction from baseline (–2.3%) than patients receiving a premixed analogue regimen (–1.7%). Adjusted mean follow-up HbA_1c was 6.9% versus 7.5%, respectively (difference, –0.59%; P < 0.01). The glargine/glulisine group also used a lower mean number of OADs (0.86 vs 1.14; difference, –0.28; P = 0.04) but had a higher weight (240 vs 235 lb; difference, 4.55 lb; P = 0.03) than the premixed analogue group at follow-up. There were no significant differences in daily insulin dose and rates of hypoglycemia. Overall medication costs per 1.0% reduction in HbA_1c were $841 with glargine/glulisine and $1308 with premixed analogues.

Conclusions

Overall, treatment with glargine/glulisine provided greater improvement in glycemic control and may represent a more cost-effective treatment option than premixed regimens for patients with type 2 diabetes in real-world clinical practice. However, due to the pragmatic trial design, the study concluded before follow-up assessments were available for all randomized patients.