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Welchol (Colesevelam Hydrochloride) - Summary

 

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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.

WELCHOL NEWS HIGHLIGHTS

Published Studies Related to Welchol (Colesevelam)

Effects of colesevelam hydrochloride (WelChol) on biomarkers of inflammation in patients with mild hypercholesterolemia. [2006.09.01]

Colesevelam HCl reduces LDL particle number and increases LDL size in hypercholesterolemia. [2006.04]

Safety and efficacy of colesevelam hydrochloride in combination with fenofibrate for the treatment of mixed hyperlipidemia. [2005.09]

Effects of colesevelam HC1 on sterol and bile acid excretion in patients with type IIa hypercholesterolemia. [2005.07]

Colesevelam HCl and ezetimibe combination therapy provides effective lipid-lowering in difficult-to-treat patients with hypercholesterolemia. [2005.07]

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Clinical Trials Related to Welchol (Colesevelam)

Effects on Colesevelam HC1 (WelCholŽ) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus [Completed]

Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes [Completed]

WelCholŽ and Insulin in Treating Patients With Type 2 Diabetes [Completed]

WelCholŽ and Sulfonylurea in Treating Patients With Type 2 Diabetes [Completed]

WelCholŽ With Metformin in Treating Patients With Type 2 Diabetes [Completed]

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Page last updated: 2006-11-04

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