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)
Effect of colesevelam on liver fat quantified by magnetic resonance in
nonalcoholic steatohepatitis: a randomized controlled trial. [2012]
CONCLUSION: Colesevelam increases liver fat in patients
Colesevelam hydrochloride powder for oral suspension versus cholestyramine powder for oral suspension: comparison of acceptability and tolerability. [2011.03]
OBJECTIVE: To compare tolerability of colesevelam hydrochloride powder versus a cholesterol-lowering equivalent dose of generic cholestyramine powder, each mixed in water, by means of the validated Bile Acid Sequestrant Acceptability (BASA) Scale... CONCLUSION: Although study participants thought that the orange-colored generic cholestyramine powder had a better appearance, they also reported that colesevelam hydrochloride for oral suspension tasted better. A minority of study participants thought appearance was "very important"; a substantial majority thought taste was "very important" for potential long-term compliance.
Effects of colesevelam on LDL-C, A1c and GLP-1 levels in patients with type 1 diabetes: a pilot randomized double-blind trial. [2011.02]
AIM: colesevelam is indicated to lower low density lipoprotein cholesterol (LDL-C) in hyperlipidaemia and improve glycaemic control in adults with type 2 diabetes. This short-term pilot study evaluates its effects in type 1 diabetes... CONCLUSIONS: during this short-term pilot study, colesevelam treatment effectively lowered LDL-C in patients with type 1 diabetes. Improvements in A1c seen at week 4 were not sustained. Effects on glycaemic control in subjects with type 1 diabetes may be related to a postprandial rise in GLP-1 levels and require further clinical study.
Colesevelam hydrochloride powder for oral suspension versus cholestyramine powder
for oral suspension: comparison of acceptability and tolerability. [2011]
Scale... CONCLUSION: Although study participants thought that the orange-colored generic
Effects of colesevelam on LDL-C, A1c and GLP-1 levels in patients with type 1
diabetes: a pilot randomized double-blind trial. [2011]
diabetes. This short-term pilot study evaluates its effects in type 1 diabetes... CONCLUSIONS: during this short-term pilot study, colesevelam treatment
Clinical Trials Related to Welchol (Colesevelam)
Effects on Colesevelam HC1 (WelCholŽ) 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 WelCholŽ
(colesevelam) may improve blood glucose control in patients with type 2 diabetes
Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes [Recruiting]
The purpose of this study is to obtain continuous glucose monitoring (CGM) data from
individuals taking Welchol compared to placebo. The CGM data will determine the effect on
glucose control of adding Welchol to an anti-diabetic medication regimen.
Colesevelam Pediatric Type 2 Diabetes Mellitus Study [Recruiting]
Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM)
to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have
been treated with Metformin or have had no antidiabetic drug treatment in the previous three
months.
Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well
tolerated, and shows improved blood sugar control (as evidenced by a significant change from
baseline in hemoglobin A1C [HbA1c]).
Welchol as Monotherapy for Type 2 Diabetes Mellitus [Recruiting]
The current study investigates Welchol as monotherapy to improve glycemic control in
subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise
alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be
safe, well tolerated and efficacious.
Reports of Suspected Welchol (Colesevelam) Side Effects
Constipation (11),
Weight Decreased (8),
OFF Label USE (6),
Dizziness (6),
Gastrointestinal Pain (6),
Diarrhoea (6),
Bronchial Secretion Retention (5),
Headache (5),
Treatment Noncompliance (5),
Nausea (5), more >>
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