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

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.

• Authors: Julio Rosenstock, Eric Hernandez-Triana, Yehuda Handelsman, Soamnauth Misir, Michael R Jones, Sukumar Nagendran
• Journal: Postgraduate medicine (Postgrad Med) Vol. 124 Issue 4 Pg. 7-13 (Jul 2012) ISSN: 1941-9260 [Electronic] England
• PMID: 22913889 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticholesteremic Agents
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Lipoproteins
• Allylamine
• Metformin
• Cholesterol
• Colesevelam Hydrochloride

Topics

• Allylamine (adverse effects, analogs & derivatives, therapeutic use)
• Anticholesteremic Agents (adverse effects, therapeutic use)
• Cholesterol (blood)
• Colesevelam Hydrochloride
• Diabetes Mellitus, Type 2 (drug therapy, ethnology)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Glycated Hemoglobin (analysis)
• Hispanic or Latino
• Humans
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Lipoproteins (blood)
• Male
• Metformin (adverse effects, therapeutic use)
• Treatment Outcome