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Welchol (Colesevelam Hydrochloride) - Summary

 
 



WELCHOL SUMMARY

WELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide.

Primary Hyperlipidemia

WELCHOL is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin).

WELCHOL is indicated as monotherapy or in combination with a statin to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:

  a. LDL-C remains ≥ 190 mg/dL or   b. LDL-C remains ≥ 160 mg/dL and

  • there is a positive family history of premature cardiovascular disease or
  • two or more other CVD risk factors are present in the pediatric patient.

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate [See Clinical Studies ()]. 14.1

In patients with coronary heart disease (CHD) or CHD risk equivalents such as diabetes mellitus, LDL-C treatment goals are < 100 mg/dL. An LDL-C goal of < 70 mg/dL is a therapeutic option on the basis of recent trial evidence. If LDL-C is at goal but the serum triglyceride (TG) value is > 200 mg/dL, then non-HDL cholesterol (non-HDL-C) (total cholesterol [TC] minus high density lipoprotein cholesterol [HDL-C]) becomes a secondary target of therapy. The goal for non-HDL-C in persons with high serum TG is set at 30 mg/dL higher than that for LDL-C.

Type 2 Diabetes Mellitus

WELCHOL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [See Clinical Studies ()]. 14.2

Diabetes mellitus is considered a CHD risk equivalent. In addition to glycemic control, intensive lipid control is warranted [See Indications and Usage () and Warnings and Precautions ()]. 1.1 5.2

Important Limitations of Use

  • WELCHOL should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • WELCHOL has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor.
  • WELCHOL has not been studied in pediatric patients with type 2 diabetes.
  • WELCHOL has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
  • WELCHOL has not been studied in children younger than 10 years of age or in pre-menarchal girls.

See all Welchol indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Welchol (Colesevelam)

The efficacy of colesevelam HCl in the treatment of heterozygous familial hypercholesterolemia in pediatric and adult patients. [2013]
the use of colesevelam in the treatment of heterozygous FH... CONCLUSIONS: Currently available data demonstrate that colesevelam, alone or in

Diurnal glucose profiles using continuous glucose monitoring to identify the glucose-lowering characteristics of colesevelam HCl (Welchol). [2013]
determine whether C-HCl significantly increased the risk of hypoglycemia... CONCLUSIONS: AGP analysis of CGM visually and quantitatively showed immediate and

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.

more studies >>

Clinical Trials Related to Welchol (Colesevelam)

Does Welchol (Colesevelam Hydrochloride) Improve Colonic Transit in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)? [Completed]
Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome. This effect is thought to result from the effect of the medication on bile acids, which can cause diarrhea.

Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus [Completed]
This is a prospective, randomized, double blind, parallel, placebo controlled clinical trial evaluating the efficacy of colesevelam HCl in reducing LDL in subjects with type 1 diabetes mellitus over a 12 week treatment period. The aim is to highlight the effect of colesevelam on LDL cholesterol and glycemia in a type 1 diabetic population. The colesevelam group is anticipated to demonstrate a mean reduction in LDL by 10% compared to the placebo group, indicated by A1c and glycemic target range CGM readings.

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.

Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes [Completed]
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]).

more trials >>

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 >>


Page last updated: 2014-11-30

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