二甲双胍联合考来维仑治疗早期 2 型糖尿病初治西班牙裔患者的初始联合治疗。

Initial combination therapy with metformin plus colesevelam in drug-naïve Hispanic patients with early type 2 diabetes.

机构信息

Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX 75230, USA.

出版信息

Postgrad Med. 2012 Jul;124(4):7-13. doi: 10.3810/pgm.2012.07.2560.

DOI:10.3810/pgm.2012.07.2560

PMID:22913889

Abstract

OBJECTIVE

To evaluate initial combination therapy with metformin plus colesevelam in drug-naïve Hispanic patients with type 2 diabetes mellitus.

RESEARCH DESIGN AND METHODS

Patients self-identified as Hispanic from a previous study were included in this exploratory post hoc analysis. Patients were randomized to metformin plus colesevelam or metformin plus placebo. The primary efficacy parameter was the mean change in glycated hemoglobin (HbA1c) levels from baseline.

RESULTS

Metformin plus colesevelam had a greater mean HbA1c reduction (-1.2 ± 0.1%) than metformin plus placebo (-0.8 ± 0.1%; P = 0.001) from mean baselines of 7.7% and 7.6%, respectively. Low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein (apo) B levels were also reduced (P < 0.0001 for all), while triglyceride (P < 0.0001) and apoA-I (P < 0.05) levels were increased with metformin plus colesevelam treatment compared with metformin plus placebo. With metformin plus colesevelam versus metformin plus placebo, more patients achieved an HbA1c of < 7.0% (75% vs 56%) and LDL-C of < 100 mg/dL (49% vs 14%; both P < 0.05).

CONCLUSION

Metformin plus colesevelam may be an effective initial treatment option for Hispanic patients with early type 2 diabetes mellitus.

摘要

目的

评估二甲双胍联合考来维仑在初诊的 2 型糖尿病西班牙裔患者中的初始联合治疗效果。

研究设计和方法

本探索性事后分析纳入了来自先前研究的自认为是西班牙裔的患者。患者被随机分配至接受二甲双胍联合考来维仑或二甲双胍联合安慰剂治疗。主要疗效参数为从基线水平开始的糖化血红蛋白（HbA1c）水平的平均变化。

结果

与接受二甲双胍联合安慰剂治疗的患者相比（分别为-0.8 ± 0.1%和 7.6%），接受二甲双胍联合考来维仑治疗的患者的 HbA1c 平均降幅更大（-1.2 ± 0.1%；P = 0.001），基线平均 HbA1c 水平分别为 7.7%和 7.6%。低密度脂蛋白胆固醇（LDL-C）、非高密度脂蛋白胆固醇、总胆固醇和载脂蛋白（apo）B 水平也降低（所有 P < 0.0001），而接受二甲双胍联合考来维仑治疗的患者的甘油三酯（P < 0.0001）和 apoA-I（P < 0.05）水平升高。与接受二甲双胍联合安慰剂治疗相比，接受二甲双胍联合考来维仑治疗的患者中有更多的患者达到了 HbA1c < 7.0%（75% vs 56%）和 LDL-C < 100 mg/dL（49% vs 14%；均 P < 0.05）。