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种族/民族对常用胰岛素方案在 2 型糖尿病中的疗效和安全性的影响:临床试验的事后分析。

Impact of race/ethnicity on the efficacy and safety of commonly used insulin regimens: a post hoc analysis of clinical trials in type 2 diabetes mellitus.

机构信息

Department of Medicine, University of Texas Southwestern Medical School, Dallas, Texas 75248, USA.

出版信息

Endocr Pract. 2010 Sep-Oct;16(5):818-28. doi: 10.4158/EP09285.OR.

DOI:10.4158/EP09285.OR
PMID:20439249
Abstract

OBJECTIVE

To explore the impact of race/ethnicity on the efficacy and safety of commonly used insulin regimens in patients with type 2 diabetes mellitus.

METHODS

In this post hoc analysis, pooled data from 11 multinational clinical trials involving 1455 patients with type 2 diabetes were used to compare specific insulin treatments in Latino/Hispanic, Asian, African-descent, and Caucasian patients. Insulin treatments included once daily insulin glargine or neutral protamine Hagedorn (BASAL), insulin lispro mix 75/25 twice daily (LMBID), or insulin lispro mix 50/50 three times daily (LMTID).

RESULTS

Race/ethnicity was associated with significant outcome differences for each of the insulin regimens. BASAL therapy was associated with greater improvement in several measures of glycemic control among Latino/Hispanic patients compared with Caucasian patients (lower end point hemoglobin A1c, greater reduction in hemoglobin A1c from baseline, and a larger proportion of patients achieving hemoglobin A1c level <7%). In contrast, LMBID therapy was associated with higher end point hemoglobin A1c and a smaller decrease in hemoglobin A1c from baseline in Latino/Hispanic and Asian patients than in Caucasian patients. Furthermore, fewer Asian patients attained a hemoglobin A1c level <7% than did Caucasians patients. For LMTID therapy, hemoglobin A1c outcomes were comparable across patient groups. Fasting blood glucose and glycemic excursions varied among racial/ethnic groups for the 3 insulin regimens. Weight change was comparable among racial/ethnic groups in each insulin regimen. During treatment with LMTID, Asian patients experienced higher incidence and rate of severe hypoglycemia than Caucasian patients.

CONCLUSIONS

Latino/Hispanic, Asian, and African-descent patients with type 2 diabetes show different metabolic responses to insulin therapy, dependent in part on insulin type and regimen intensity.

摘要

目的

探讨种族/民族对 2 型糖尿病患者常用胰岛素方案疗效和安全性的影响。

方法

本事后分析采用来自涉及 1455 例 2 型糖尿病患者的 11 项多国临床试验的汇总数据,比较了拉丁裔/西班牙裔、亚裔、非裔和白种人患者中特定胰岛素治疗的情况。胰岛素治疗包括每日 1 次甘精胰岛素或中性鱼精蛋白锌胰岛素(BASAL)、每日 2 次赖脯胰岛素混合 75/25(LMBID)或每日 3 次赖脯胰岛素混合 50/50(LMTID)。

结果

种族/民族与每种胰岛素方案的显著结局差异相关。与白种人患者相比,BASAL 治疗与拉丁裔/西班牙裔患者的多项血糖控制指标的更大改善相关(更低的终点血红蛋白 A1c,从基线的血红蛋白 A1c 更大降幅,以及更大比例的患者达到血红蛋白 A1c 水平<7%)。相比之下,LMBID 治疗与拉丁裔/西班牙裔和亚裔患者的终点血红蛋白 A1c 较高以及从基线的血红蛋白 A1c 降幅较小相关。此外,达到血红蛋白 A1c<7%的亚裔患者比例低于白种人患者。对于 LMTID 治疗,不同患者群体的血红蛋白 A1c 结局相当。3 种胰岛素方案中,空腹血糖和血糖波动在不同种族/民族群体之间存在差异。每种胰岛素方案中,体重变化在不同种族/民族群体之间相当。在接受 LMTID 治疗期间,亚洲患者发生严重低血糖的发生率和速率高于白种人患者。

结论

2 型糖尿病的拉丁裔/西班牙裔、亚裔和非裔患者对胰岛素治疗的代谢反应不同,部分取决于胰岛素类型和方案强度。

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