Colesevelam hydrochloride to treat hypercholesterolemia and improve glycemia in prediabetes: a randomized, prospective study.

Objective: To assess the effect of the bile acid sequestrant colesevelam hydrochloride in patients with hypercholesterolemia and prediabetes.

Methods: In this 16-week, randomized, double-blind study, adults with untreated prediabetes (2-hour postoral glucose tolerance test [OGTT] glucose > or =140 to 199 mg/dL, fasting plasma glucose [FPG] > or =110 to 125 mg/dL, or both), low-density lipoprotein cholesterol (LDL-C) > or =100 mg/dL, and triglycerides <500 mg/dL were randomly assigned to receive colesevelam (3.75 g/d) or placebo.

Initial combination therapy with metformin and colesevelam for achievement of glycemic and lipid goals in early type 2 diabetes.

Objective: To evaluate the efficacy and safety of initial combination therapy with metformin plus colesevelam in patients with early type 2 diabetes.

Methods: In this 16-week, randomized, double-blind, placebo-controlled study, adults with type 2 diabetes (hemoglobin A1c [A1C] values of 6.5% to 10.

The effect of colesevelam hydrochloride on insulin sensitivity and secretion in patients with type 2 diabetes: a pilot study.

Background: This study evaluated the effect of colesevelam hydrochloride on insulin sensitivity, potential binding to glucose, and chronic effect(s) on fasting and postprandial glucose and insulin in patients with type 2 diabetes mellitus.

Methods: Patients meeting inclusion criteria were withdrawn from all antidiabetes agents for 2 weeks and randomized to colesevelam 3.75 grams/day (n = 17) or placebo (n = 18) for 8 weeks.

Colesevelam HCl improves fasting plasma glucose and lipid levels in patients with prediabetes.

Although colesevelam hydrochloride (HCl) is indicated to reduce low-density lipoprotein cholesterol (LDL-C) in patients with hyperlipidemia and improve glycemic control in patients with type 2 diabetes, its effects on glucose and lipids in patients with prediabetes have not been previously studied. To evaluate the effects of colesevelam HCl in patients with prediabetes, a post-hoc analysis was conducted on data from a 24-week lipid-lowering study. Using baseline laboratory safety data for fasting plasma glucose (FPG), 88 patients were identified as having prediabetes according to American Diabetes Association criteria.

Effects of colesevelam, rosiglitazone, or sitagliptin on glycemic control and lipid profile in patients with type 2 diabetes mellitus inadequately controlled by metformin monotherapy.

Objective: To evaluate the glycemic effect of colesevelam, rosiglitazone, or sitagliptin when added to metformin monotherapy in patients with type 2 diabetes mellitus (DM) and to examine the effects of these antidiabetes agents on lipid and lipoprotein levels.

Methods: This 16-week, open-label pilot study conducted between May 2007 and April 2008 at 20 sites in the United States, 7 sites in Mexico, and 6 sites in Colombia, enrolled adults with inadequately controlled type 2 DM (glycated hemoglobin [HbA1c], 7.0%-10.

Rationale and design of a clinical trial to evaluate metformin and colesevelam HCl as first-line therapy in type 2 diabetes and colesevelam HCl in prediabetes.

Objective: The complications of type 2 diabetes mellitus (DM) can begin early in the progression from impaired glucose tolerance to type 2 DM. Metformin is recommended as initial drug therapy for managing hyperglycemia in type 2 DM. The bile acid sequestrant colesevelam hydrochloride (HCl) is approved in the United States for glycemic control in adults with type 2 DM.

Concomitant reduction in low-density lipoprotein cholesterol and glycated hemoglobin with colesevelam hydrochloride in patients with type 2 diabetes: a pooled analysis.

Colesevelam hydrochloride (COL), a bile acid sequestrant indicated as an adjunct to diet and exercise for reducing low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia, was shown in a pilot study to reduce both glycated hemoglobin (HbA1c) and LDL-C in patients with type 2 diabetes mellitus (T2DM). Three double-blind, placebo-controlled trials in T2DM have now independently confirmed the HbA1c and LDL-C reductions with COL. In each of the primary studies, a significant mean treatment difference in HbA1c (-0.

Colesevelam HCl effects on atherogenic lipoprotein subclasses in subjects with type 2 diabetes.

Research Design And Methods: Glucose-Lowering Effect of Welchol Study (GLOWS) was a randomized, double-blind, placebo-controlled trial to examine the effects of colesevelam HCl on glycemic and lipid control in type 2 diabetes patients with HbA1c (A1C) between 7.0% and 10.0%.

Lipid-lowering effects of colesevelam HCl in combination with ezetimibe.

Objective: The primary aim of this study was to compare the effect of colesevelam HCl in combination with ezetimibe to ezetimibe monotherapy on low-density lipoprotein cholesterol (LDL-C) levels in subjects with primary hypercholesterolemia.

Methods: Subjects with primary hypercholesterolemia (N = 86) were enrolled in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. After a 4- to 8-week washout period, subjects received colesevelam HCl 3.

Effects of colesevelam hydrochloride on low-density lipoprotein cholesterol and high-sensitivity C-reactive protein when added to statins in patients with hypercholesterolemia.

Elevated high-sensitivity C-reactive protein (hs-CRP) levels are associated with an increased risk of atherosclerotic coronary heart disease (CHD). The addition of the bile acid sequestrants, such as colesevelam hydrochloride (HCl), to statins further reduces low-density lipoprotein (LDL) cholesterol levels. However, the effects of approved cholesterol-lowering bile acid sequestrants on hs-CRP have not previously been reported.

Safety and efficacy of colesevelam hydrochloride in combination with fenofibrate for the treatment of mixed hyperlipidemia.

Objective: The aim of this study was to evaluate the amount of low-density lipoprotein cholesterol (LDL-C) reduction achieved by adding the specifically engineered bile acid sequestrant (SE-BAS) colesevelam HCl to a stable dose of fenofibrate in patients with mixed hyperlipidemia.

Research Design And Methods: Patients with mixed hyperlipidemia (n = 129) were enrolled in a randomized, double-blind, placebo-controlled, parallel-group study investigating the efficacy of fenofibrate plus colesevelam HCl versus fenofibrate monotherapy. After a 4- to 8-week washout period, subjects received fenofibrate 160 mg/day for 8 weeks and were then randomized to receive colesevelam HCl 3.