WELCHOL SUMMARY
WelChol® contains colesevelam hydrochloride (hereafter referred to as colesevelam), a non-absorbed, polymeric, lipid-lowering agent intended for oral administration. Colesevelam is a high capacity bile acid binding molecule. Colesevelam is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. Colesevelam is hydrophilic, and insoluble in water.
WelChol® , administered alone or in combination with an HMG-CoA reductase inhibitor, is indicated as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa).
Therapy with lipid lowering agents should be a component of multiple risk-factor intervention in patients at significant increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol and when the response to diet and other non-pharmacological means has been inadequate.
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NEWS HIGHLIGHTS
Published Studies Related to Welchol (Colesevelam)
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. [2009.09]
CONCLUSION: A potential limitation is that there is no direct comparator for the dual glucose- and lipid-lowering effect of colesevelam HCl in the prediabetes cohort. However, results of this trial will help to define the extent to which colesevelam HCl can help improve cardiometabolic risk factors for complications of type 2 DM in the first-line environment, and will also indicate the extent to which early intervention with colesevelam HCl can help to correct metabolic abnormalities associated with prediabetes.
Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. [2008.10.13]
BACKGROUND: Bile acid sequestrants are a well-accepted class of cholesterol-lowering drugs. Over the last decade, small studies have indicated that these agents may also lower glucose levels in patients with type 2 diabetes mellitus (T2DM)... CONCLUSION: Colesevelam improves glycemic and lipid parameters in patients with T2DM inadequately controlled with metformin-based therapy.
Colesevelam HCl effects on atherogenic lipoprotein subclasses in subjects with type 2 diabetes. [2008.10.05]
CONCLUSIONS: In type 2 diabetes patients, colesevelam improves glycemic status and reduces the concentration of LDL-C and LDL-P with little change in concentrations of other lipoprotein particles.
Effects of colesevelam hydrochloride (WelChol) on biomarkers of inflammation in patients with mild hypercholesterolemia. [2006.09.01]
Inflammation is pivotal in atherogenesis. High-sensitivity C-reactive protein (hs-CRP), the prototypic marker of inflammation, has been shown to predict cardiovascular events... In conclusion, our results show that colesevelam HCl monotherapy significantly lowered hs-CRP levels in a double-blind, placebo-controlled study.
Colesevelam HCl reduces LDL particle number and increases LDL size in hypercholesterolemia. [2006.04]
BACKGROUND: Although LDL-cholesterol (LDL-C) remains the target of cholesterol-lowering therapy, high levels of LDL particle numbers better differentiate cardiovascular risk than LDL-C concentrations. Colesevelam HCl, a novel bile acid sequestrant, has also been shown to reduce mean LDL-C by 18% with the maximum dose. The effect of colesevelam HCl on LDL particle number and particle size has not been previously published. LDL particle number and particle size were measured by NMR spectroscopy... CONCLUSION: For patients with moderate hypercholesterolemia, treatment with colesevelam HCl at the recommended starting dose of 3.75 g/d lowered LDL particle number, and increased mean LDL particle size.
Clinical Trials Related to Welchol (Colesevelam)
Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus [Completed]
This study is designed to test whether WelChol (colesevelam HC1) improves blood sugar control
in patients with type 2 diabetes by making their own insulin work more efficiently.
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes [Completed]
This study is designed to assess the potential mechanism of action by which WelChol®
(colesevelam) may improve blood glucose control in patients with type 2 diabetes
WelChol® and Insulin in Treating Patients With Type 2 Diabetes [Completed]
The purpose of the study is to see how safe and effective and tolerable the use of WelChol®
is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic
drugs
WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes [Completed]
The purpose of the study is to see how safe and effective and tolerable the use of
colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in
combination with other anti-diabetic drugs.
WelChol® With Metformin in Treating Patients With Type 2 Diabetes [Completed]
The purpose of the study is to see how safe and effective and tolerable the use of
colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in
combination with other anti-diabetic drugs.
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