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Colesevelam Diabetes

Atypical Mechanism Of Glucose Modulation By Colesevelam In Patients With Type 2 Diabetes

Atypical Mechanism Of Glucose Modulation By Colesevelam In Patients With Type 2 Diabetes

Atypical Mechanism of Glucose Modulation by Colesevelam in Patients with Type 2 Diabetes 1Executive Medical Director, Therapeutic Area Head, Hypertension, Metabolism and Pain, Daiichi Sankyo, Inc., Parsippany, New Jersey, USA. 1Executive Medical Director, Therapeutic Area Head, Hypertension, Metabolism and Pain, Daiichi Sankyo, Inc., Parsippany, New Jersey, USA. 2Healthcare Consultant, Port St. Lucie, Florida, USA. Copyright 2013 the author(s), publisher and licensee Libertas Academica Ltd. This is an open-access article distributed under the terms of the Creative Commons CC-BY-NC 3.0 License. This article has been cited by other articles in PMC. Colesevelams glucose-lowering mechanism of action is not completely understood. Clinical trials of colesevelam suggest that its mechanism, and often adverse effects, differ from those of other oral antidiabetes drugs. Colesevelam does not affect insulin sensitivity (unlike thiazolidinediones), insulin secretion (unlike sulfonylureas and meglitinides), or early insulin response or glucagon (unlike dipeptidyl peptidase-4 inhibitors). Colesevelam may have some effect on glucose absorption, but likely via a different mechanism than -glucosidase inhibitors. Colesevelam and metformin have similarities regarding hepatic glucose production, but divergent effects on gluconeogenesis versus glycogenolysis, suggesting differing mechanisms of drug action for improving glycemic control. Colesevelam is thought to be a portal glucagon-like peptide-1 (GLP-1) secretagogue with primarily hepatic effects. Bile acid binding by colesevelam leads to TGR5 activation, increased secretion of GLP-1 or other incretins, and inhibition of hepatic glycogenolysis. Colesevelams mechanism of action appears to be atypical of other antidiabetes medications, maki Continue reading >>

Welchol (colesevelam) Dosing, Indications, Interactions, Adverse Effects, And More

Welchol (colesevelam) Dosing, Indications, Interactions, Adverse Effects, And More

Reduction of elevated low-density lipoprotein (LDL) cholesterol (LDL-C) in adults with primary (Fredrickson type IIa) hyperlipidemia as adjunct to diet and exercise, either alone or in combination with a statin Tablet: 1.875 g (3 tablets) PO q12hr with meals or 3.75 g (6 tablets) PO once daily with a meal Oral suspension: 1.875 g ( packet) PO q12hr or 3.75 g (1 packet) PO once daily, mixed with liquid Overdose: Symptoms include gastrointestinal (GI) obstruction; treatment is supportive Improvement of glycemic control in adults; taken in combination with insulin or oral antidiabetic agents Tablet: 1.875 g (3 tablets) PO q12hr with meals or 3.75 g (6 tablets) PO once daily with a meal Oral suspension: 1.875 g ( packet) PO q12hr or 3.75 g (1 packet) PO once daily, mixed with liquid Overdose: Symptoms include GI obstruction; treatment is supportive Tablet: Take with meals and plenty of liquid Oral suspension: Empty packet in 4-8 oz of water, fruit juice, or diet soft drink and stir; drink with meal(s) May be coadministered with statins or administered at separate times Continue reading >>

Colesevelam - Wikipedia

Colesevelam - Wikipedia

By intestines only, colesevelam is non-systemic. Colesevelam is a bile acid sequestrant administered orally. It was developed by GelTex Pharmaceuticals and later acquired by Genzyme. It is marketed in the US by Daiichi Sankyo under the brand name Welchol and elsewhere by Genzyme as Cholestagel. In Canada it is marketed by Valeant as Lodalis. Colesevelam is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia as monotherapy and to improve glycemic control in adults with type 2 diabetes mellitus , [1] including in combination with a statin . The expanded use of colesevelam in adults with type 2 diabetes mellitus is an example of drug repositioning . Colesevelam is one of the bile-acid sequestrants , which along with niacin and the statins, are the three main types of cholesterol-lowering agents. The statins are considered the first-line agents. This is because of the larger body of evidence supporting statins' ability to prevent cardiovascular disease, as well as the prominent side effects from the other two types, including bloating and constipation (bile-acid sequestrants) and skin flushing (niacin). These side effects often lead to low patient compliance. [2] Colesevelam is a modified polyallylamine. It is made by crosslinking polyallylamine with epichlorohydrin, and then modifying it with bromodecane and (6-bromohexyl)trimethylammonium bromide. The bromide ions are then replaced with chloride ions when the material is washed. [6] The constituents of the polymer colesevelam shown as subunits that do not exist per se in the final product are: N-prop-2-enyldecan-1-amine; trimethyl-[6-(prop-2-enylamino)hexyl]azanium; prop-2-en-1-amine; 2-(chloromethyl)oxirane; hydrogen chloride Continue reading >>

Efficacy And Safety Of Colesevelam In Patients With Type 2 Diabetes Mellitus And Inadequate Glycemic Control Receiving Insulin-based Therapy

Efficacy And Safety Of Colesevelam In Patients With Type 2 Diabetes Mellitus And Inadequate Glycemic Control Receiving Insulin-based Therapy

Flowchart shows subject participation. ITT represents intent-to-treat. Least squares mean (SEM) change from baseline in glycated hemoglobin A1c (HbA1c) (A), fasting plasma glucose (FPG) (B), and fructosamine (C) levels in subjects (intent-to-treat population without last observation carried forward imputation) receiving colesevelam hydrochloride, 3.75 g/d, or placebo for 16 weeks. *P<.05 vs placebo. P<.01 vs placebo. P<.001 vs placebo. To convert glucose to millimoles per liter, multiply by 0.0555; HbA1c to a proportion of total hemoglobin, multiply by 0.01. Least squares mean percent change from baseline in lipid and lipoprotein levels in subjects (intent-to-treat population with last observation carried forward imputation) receiving colesevelam hydrochloride, 3.75 g/d, or placebo for 16 weeks. Triglyceride levels (TG) are reported as median rather than mean. The numbers above the bracketed pairs of bars refer to the differences between the mean or median change in the group receiving placebo and the mean or median change in the group receiving colesevelam. LDL-C indicates low-density lipoprotein cholesterol; nonHDL-C, nonhigh-density lipoprotein cholesterol; TG, triglycerides; TC, total cholesterol; TG, triglycerides; HDL-C, high-density lipoprotein cholesterol; ApoA-I, apolipoprotein A-I; ApoB, apolipoprotein B. *P<.001. P<.05. Least squares mean change from baseline in lipid and lipoprotein ratios in subjects (intent-to-treat population with last observation carried forward imputation) receiving colesevelam hydrochloride, 3.75 g/d, or placebo for 16 weeks. The numbers above the bracketed pairs of bars refer to the differences between the mean or median change in the group receiving placebo and the mean or median change in the group receiving colesevelam. TC indicat Continue reading >>

Welchol Mechanism Of Action

Welchol Mechanism Of Action

Welchol is indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin) reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia, as monotherapy or in combination with a statin after failing an adequate trial of diet therapy improve glycemic control in adults with type 2 diabetes mellitus 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 Fredrickson Type I, III, IV, and V dyslipidemias Welchol has not been studied in children younger than 10 years of age or in premenarchal girls IMPORTANT SAFETY INFORMATION ABOUT WELCHOL (colesevelam HCI) individuals with a history of bowel obstruction those with serum triglyceride (TG) concentrations of >500 mg/dL, or those with a history of hypertriglyceridemia-induced pancreatitis. The effect of Welchol on cardiovascular morbidity and mortality has not been determined. Welchol can increase serum TG concentrations particularly when used in combination with pioglitazone, sulfonylureas, or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL. Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficienc Continue reading >>

Effect Of Colesevelam Hcl Monotherapy On Lipid Particles In Type 2 Diabetes Mellitus

Effect Of Colesevelam Hcl Monotherapy On Lipid Particles In Type 2 Diabetes Mellitus

, Volume 28, Issue3 , pp 229236 | Cite as Effect of Colesevelam HCl Monotherapy on Lipid Particles in Type 2 Diabetes Mellitus In addition to lowering hemoglobin A1C, colesevelam has been shown to improve the atherogenic lipoprotein profile of subjects with type 2 diabetes mellitus (T2DM) when used in combination with metformin and/or sulfonylureas. A recent study evaluated the effects of colesevelam as antidiabetes monotherapy in adults with T2DM who had inadequate glycemic control (hemoglobin A1C 7.5 to 9.5%) with diet and exercise alone; we report here the effects on lipoprotein particle subclasses. Subjects were randomized to receive oral colesevelam 3.75g/day (n = 176) or placebo (n = 181) for 24weeks. Changes in lipoprotein particle subclasses were determined by nuclear magnetic resonance spectroscopy. At Week 24 with last observation carried forward, colesevelam produced a reduction in total low-density lipoprotein (LDL) particle concentration (baseline: 1,611nmol/L; least-squares [LS] mean treatment difference: 143nmol/L, p < 0.0001) versus placebo; reductions were also seen in large, small, and very small LDL particle concentrations (all p < 0.05). There was also a reduction in total very low-density lipoprotein (VLDL) and chylomicron particle concentration (baseline: 88nmol/L; LS mean treatment difference: 1nmol/L, p = 0.82) that resulted from a lowering in small VLDL particle concentration (baseline: 45nmol/L; LS mean treatment difference: 5nmol/L, p = 0.03). In addition, with colesevelam there was an increase in total high-density lipoprotein (HDL) particle concentration versus placebo (baseline: 31mol/L; LS mean treatment difference: +0.6mol/L, p = 0.20), due to increases in the large (baseline: 5mol/L; LS mean treatment difference: +0.5mol/L, p = 0.007) a Continue reading >>

How Does Colesevelam (welchol) Work To Treat Type 2 Diabetes?

How Does Colesevelam (welchol) Work To Treat Type 2 Diabetes?

How does colesevelam (Welchol) work to treat type 2 diabetes? Colesevelam lowers bad (LDL) cholesterol and improves blood sugar control in adults with type 2 diabetes. Your doctor will call this type of drug a bile acid sequestrant. News release, FDA. . . WebMD Health News: "FDA Restricts Use of Diabetes Drug Avandia." News release, FDA. Reviewed by Michael Dansinger on February 26, 2017 News release, FDA. . . WebMD Health News: "FDA Restricts Use of Diabetes Drug Avandia." News release, FDA. How does linagliptin (Tradjenta) work to treat type 2 diabetes? THIS TOOL DOES NOT PROVIDE MEDICAL ADVICE. It is intended for general informational purposes only and does not address individual circumstances. It is not a substitute for professional medical advice, diagnosis or treatment and should not be relied on to make decisions about your health. Never ignore professional medical advice in seeking treatment because of something you have read on the WebMD Site. If you think you may have a medical emergency, immediately call your doctor or dial 911. This tool does not provide medical advice. See additional information. Continue reading >>

Colesevelam Lowers Glucose And Lipid Levels In Type 2 Diabetes: The Clinical Evidence

Colesevelam Lowers Glucose And Lipid Levels In Type 2 Diabetes: The Clinical Evidence

Colesevelam lowers glucose and lipid levels in type 2 diabetes: the clinical evidence 3Universit Lille Nord de France, Lille, France 1Tulane University Health Sciences Center in New Orleans, New Orleans, LA, USA 2Metabolic Institute of America, Tarzana, CA, USA 3Universit Lille Nord de France, Lille, France 6Institut Pasteur de Lille, Lille, France Correspondence to: Vivian A. Fonseca, MD, Professor of Medicine and Pharmacology, Tullis Tulane Alumni Chair in Diabetes, Chief Section of Endocrinology, Tulane University Health Sciences Center in New Orleans, 1430 Tulane Avenue SL 53, New Orleans, LA 70112, USA. E-mail: [email protected] Received 2009 Aug 12; Revised 2009 Oct 15; Accepted 2009 Nov 6. Copyright 2010 Blackwell Publishing Ltd Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. This article has been cited by other articles in PMC. Simultaneous control of blood glucose and other risk factors such as hypertension and dyslipidaemia is essential for reducing the risk of complications associated with type 2 diabetes mellitus (T2DM). As relatively few patients with T2DM have their risk factors managed to within the limits recommended by the American Diabetes Association, American College of Endocrinology or National Cholesterol Education Program Adult Treatment Panel III guidelines, treatment that can simultaneously control more than one risk factor is of therapeutic benefit. Clinical studies have shown that bile acid sequestrants have glucose-lowering effects in addition to their low-density lipoprotein cholesterol-lowering effects in patients with T2DM. The bile acid sequestrant colesevelam hydrochloride is approved as an adjunct to antidiabetes therapy for improving gl Continue reading >>

Welchol New Fda Drug Approval | Centerwatch

Welchol New Fda Drug Approval | Centerwatch

Welchol contains colesevelam hydrochloride, a non-absorbed,polymeric, lipid-lowering and glucose-lowering agent. It works bybinding bile acids, including the major bile acid in humans knownas glycocholic acid. However, the exact mechanism by which Welcholimproves glycemic control is unknown. Welchol is specifically indicated as an adjunct to diet andexercise to improve glycemic control in adults with type 2 diabetesmellitus. Welchol is supplied as a 625 mg tablet designed for oraladministration. The recommended initial dose of the drug is 6tablets once daily or 3 tablets twice daily. Welchol should betaken with a meal and liquid. The FDA approval of Welchol for this indication was based on theresults of three clinical trials. These double-blind,placebo-controlled add-on therapy trials enrolled a total of 1,018subjects with baseline A1C 7.5-9.5%. The subjects received Welchol,in combination with metformin, sulfonylureas or insulin or placeboadministered either as 3 tablets twice daily with lunch and dinneror as 6 tablets with dinner alone. Add-on Combination Therapy withMetformin: Welchol 3.8 g/day or placebo was added to background anti-diabetictherapy in a 26-week trial of 316 subjects already receivingtreatment with metformin alone (N=159) or metformin in combinationwith other oral agents (N=157). The combination of Welchol plusmetformin resulted in statistically significant placebo-correctedreductions in A1C with a -0.6 treatment difference (p<0.001) andFPG with a -14 treatment difference (p=0.10). The mean percentchange in serum LDL-C levels with Welchol compared to placebo was-16% among statin users and statin non-users; the median percentchange in serum TG levels with Welchol compared to placebo was -2%among statin users and 10% among statin non-users. The mean c Continue reading >>

Bile Acid Sequestrants (colesevelam, Welchol)

Bile Acid Sequestrants (colesevelam, Welchol)

Bile Acid Sequestrants (Colesevelam, Welchol) Bile acid sequestrants (BAS) are cholesterol-lowering medications that also lower blood sugar levels in people with type 2 diabetes . This class of drug helps to get rid of cholesterol in the body, especially the harmful cholesterol known as LDL cholesterol. It is common for people with diabetes to have elevated LDL cholesterol. These medications were originally developed to treat hypercholesterolemia. They were found by a study mentioned in Diabetes Care to reduce coronary heart disease, death, and nonfatal heart attacks by 19% compared to a placebo in those with hypercholesterolemia. The way these drugs workis by the medicationbinding with bile acids in the digestive system which are then replaced in the body by cholesterol, effectively lowering cholesterol. This is because bile acids are made in the body when cholesterol is broken down. Below is a visual to show the difference between a BAS method ofgetting rid of cholesterol versus a statins method: Colesevelam (Welchol) is the only BAS approved for lowering blood sugar in patients with type 2 diabetes in the US. Colesevelam was studied in a clinical trial which showed that it not only helped lower blood sugar but LDL cholesterol in patients with type 2 diabetes. Colestimide and colestilan are currently approved for use for type 2 diabetes in Japan. Safety and Side Effectsof Bile Acid Sequestrants BAS medications are not absorbed into the bloodstream and work well for patients who might not be able to safely take certain medications due to their liver. Patients may notice common side effects like indigestion,gas,and mild or moderate constipation but studies have shown colesevelamto be well tolerated by patients and to not cause weight gain . In a study checking the safe Continue reading >>

Colesevelam Hydrochloride For The Treatment Of Type 2 Diabetes Mellitus

Colesevelam Hydrochloride For The Treatment Of Type 2 Diabetes Mellitus

Volume 31, Issue 2 , February 2009, Pages 245-259 Colesevelam hydrochloride for the treatment of type 2 diabetes mellitus Author links open overlay panel Travis E.SonnettPharmD1 Get rights and content Background: Colesevelam hydrochloride is a bile acid sequestrant approved in January 2008 by the US Food and Drug Administration (FDA) for the treatment of adult patients with type 2 diabetes mellitus (DM) in combination with a sulfonylurea, metformin, and/or insulin therapy. Objective: The purpose of this article was to review the pharmacology, pharmacokinetics, efficacy, adverse effects and tolerability, drug-drug interactions, contraindications/precautions, dosage and administration, pharmacoeconomics, and the overall role of colesevelam in the management of adult patients with type 2 DM. Methods: A literature search using MEDLINE (1966October 27, 2008), PubMed (1950October 27, 2008), Science Direct (1994October 27, 2008), Web of Science (1980October 27, 2008), American Diabetes Association Scientific Abstracts (20042008), and International Pharmaceutical Abstracts (1970October 27, 2008) was performed using the term colesevelam. English-language, original research and review articles were examined, and citations from these articles were assessed. Manufacturer prescribing information and the FDA review of the new drug application for colesevelam were also examined. Results: Colesevelam is a hydrophilic, water-insoluble polymer, with negligible absorption and systemic distribution, that is excreted primarily in the feces. Through a mechanism still under investigation, colesevelam effectively lowers glycosylated hemoglobin (HbA1c) when used in combination with a sulfonylurea, metformin, and/or insulin therapy. Three completed, published Phase III clinical trials investiga Continue reading >>

About Type 2 Diabetes And High Cholesterol

About Type 2 Diabetes And High Cholesterol

WELCHOL is not for those with blood triglyceride levels of > 500 mg/dL Type 2 diabetes is the more common form of diabetes1 95% of people with diabetes have type 2 diabetes2,3 More than 90% of people with type 2 diabetes are overweight or obese3 Type 2 diabetes is often associated with obesity, family history, and physical inactivity.3 Common symptoms of diabetes may include urinating often, feeling very thirsty, feeling very hungry (even though you are eating), extreme fatigue, blurry vision, cuts/bruises that are slow to heal, and tingling, pain, or numbness in the hands and/or feet (type 2). However, some people with type 2 diabetes may not experience any symptoms.4 Type 2 diabetes in adults is a chronic condition that should be taken seriously Type 2 diabetes can be associated with many serious health complications including5: Neuropathy (tingling, pain, numbness, or weakness in the feet and/or hands) Kidney disease Eye complications Skin complications High blood pressure Stroke Welchol has not been shown to prevent heart disease, heart attacks, stroke, or any of the above risks. Please see "What is Welchol® (colesevelam HCl)" and "Important Safety Information about Welchol" below. The American Diabetes Association (ADA) explains that type 2 diabetes is a problem with the body that causes blood sugar levels to be high, either because the body doesn't make enough of the insulin hormone, or the body does not use insulin properly. When your body does not use insulin properly, this is called insulin resistance. At first, the pancreas makes extra insulin to make up for it. But, over time your pancreas isn’t able to keep up and can’t make enough insulin to keep your blood sugar levels normal. Type 2 diabetes is treated with lifestyle changes (healthy eating and exerc Continue reading >>

Colesevelam Hydrochloride: A Novel Agent In Patients With Type 2 Diabetes Sekhri K, Saha L - Int J App Basic Med Res

Colesevelam Hydrochloride: A Novel Agent In Patients With Type 2 Diabetes Sekhri K, Saha L - Int J App Basic Med Res

Hyperglycemia is a risk factor for microvascular complications in patients with type 2 diabetes. [1] Apart from hyperglycemia, dyslipidemia also contributes to the risk of developing complications in patients with type 2 diabetes. [2] Even the National Cholesterol Education Program (NCEP) Adult Treatment Panel III has recommended achieving low-density lipoprotein cholesterol (LDL-C) goals of < 100 mg / dl for patients with diabetes as they are at high risk of developing cardiovascular events. [3] Thus, new treatment regimens that can improve both glycemic control and lipid management in type 2 diabetes patients will be clinically beneficial. In this regard, colesevelam hydrochloride, the LDL-C lowering medication, which is also indicated for glycemic control seems promising. [4] Colesevelam hydrochloride was previously approved as an adjunct to diet and exercise, to reduce elevated LDL-C in patients with primary hyperlipidemia. [5] On January 18, 2008, this agent was also approved as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. [4] Colesevelam is a bile acid sequestrant (BAS) with a high capacity for binding bile acids in the intestine, [5] thereby impeding their re-absorption and enterohepatic circulation. This leads to the upregulation of the hepatic enzyme, cholesterol 7-alpha-hydroxylase, causing an increase in the conversion of cholesterol to bile acids and the activity of the hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase (rate limiting step of cholesterol synthesis). The number of hepatic LDL receptors is also increased, thus increasing the clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels. The exact mechanism by which colesevelam improves glycemic control is unknown. The va Continue reading >>

Mechanisms Of Glucose Lowering Effect Of Colesevelam Hcl

Mechanisms Of Glucose Lowering Effect Of Colesevelam Hcl

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Mechanisms of Glucose Lowering Effect of Colesevelam HCl The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT00596427 Information provided by (Responsible Party): Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the potential mechanism of action is important for defining the role of the drug among oral antidiabetic agents available for use in subjects with diabetes. The objective of this study is to provide insight into the mechanisms of action of colesevelam HCl in T2DM. The mechanisms of interest include hepatic insulin sensitivity, rate of appearance of exogenous glucose and changes in incretin hormone concentrations. Colesevelam HCl (marketed in the U.S. as WelChol) is a non-absorbed polymer that binds bile acids in the intestine, impeding their reabsorption, and is indicated to lower low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia. As the bile acid pool becomes depleted, the hepatic enzyme cholesterol 7-(alpha)-hydroxylase is upregulated, increasing the conversion of cholesterol to bile acids. This causes an increased demand for cholesterol in the liver, resulting in the dual effect of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase, and increasing the numbe Continue reading >>

Common Side Effects Of Welchol (colesevelam Hcl) Drug Center - Rxlist

Common Side Effects Of Welchol (colesevelam Hcl) Drug Center - Rxlist

Tell your doctor if you have unlikely but serious side effects of Welchol including: The recommended dose of Welchol to treat primary hyperlipidemia or type 2 diabetes mellitus in adults is 6 tablets once daily or 3 tablets twice daily. Take with a meal and liquid. Do not take other medications at the same time unless your doctor has told you to, as Welchol may make it harder for your body to absorb certain other medications. Welchol may interact with phenytoin , blood thinners, glyburide , thyroid hormone replacement, or birth control pills. Tell your doctor all medications you use. During pregnancy, Welchol should be used only if prescribed. This medication is unlikely to pass into breast milk or harm a nursing infant. Consult your doctor before breastfeeding. Our Welchol (colesevelam hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Because clinical studies are conducted under widelyvarying conditions, adverse reaction ratesobserved in the clinical studies of adrug cannot be directly compared to rates in clinical studies of another drugand may not reflect the rates observed in practice. In 7 double-blind, placebo-controlled, clinical trials,807 patients with primary hyperlipidemia (age range 18-86 years, 50% women, 90%Caucasians, 7% Blacks, 2% Hispanics, 1% Asians) and elevated LDL - C were treatedwith WELCHOL 1.5 g/day to 4.5 g/day from 4 to 24 weeks (total exposure 199patient-years). In clinical trials for the reduction of LDL-C, 68% ofpatients receiving WELCHOL vs. 64% of patients re Continue reading >>

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