Colesevelam Hydrochloride

Hyperlipidemia, Physical Activity, Type 2 Diabetes + 3 more

Treatment

2 FDA approvals

20 Active Studies for Colesevelam Hydrochloride

What is Colesevelam Hydrochloride

Colesevelam

The Generic name of this drug

Treatment Summary

Colesevelam is a medication used to lower cholesterol levels in the blood. It works by binding to bile acids in the intestine and preventing them from being absorbed into the bloodstream. To help achieve the best results, Colesevelam should be taken in conjunction with a diet that restricts cholesterol and fat intake.

Welchol

is the brand name

image of different drug pills on a surface

Colesevelam Hydrochloride Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Welchol

Colesevelam

2000

42

Approved as Treatment by the FDA

Colesevelam, commonly known as Welchol, is approved by the FDA for 2 uses including Hyperlipidemia and High Cholesterol .

Hyperlipidemia

Used to treat Hyperlipidemias in combination with null

High Cholesterol

Used to treat Hyperlipidemias in combination with null

Effectiveness

How Colesevelam Hydrochloride Affects Patients

Colesevelam is a medication that helps to lower cholesterol levels by binding to bile acids in the intestine. Studies have shown that having high levels of total cholesterol, LDL cholesterol, and apolipoprotein B (Apo B) is linked to an increased risk of atherosclerosis. On the other hand, low levels of HDL cholesterol can lead to the development of atherosclerosis. Taking colesevelam in combination with another cholesterol-lowering medication can further reduce levels of total cholesterol and LDL cholesterol beyond what either medication can do on its own.

How Colesevelam Hydrochloride works in the body

Colesevelam binds to bile acids in the intestine, preventing them from being reabsorbed. Instead, it causes the body to produce more cholesterol, which is then cleared from the bloodstream. This process lowers LDL cholesterol levels, while triglyceride levels may stay the same or even increase. The end result is a decrease in LDL cholesterol in the bloodstream.

When to interrupt dosage

The measure of Colesevelam Hydrochloride is contingent upon the identified illness, such as Type 2 Diabetes, Hypercholesterolemia and Hyperlipidemia. The dosage amount is contingent upon the technique of delivery as specified in the table below.

Condition

Dosage

Administration

Physical Activity

3750.0 mg, , 625.0 mg, 1875.0 mg

, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Bar, chewable - Oral, Bar, chewable

Type 2 Diabetes

3750.0 mg, , 625.0 mg, 1875.0 mg

, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Bar, chewable - Oral, Bar, chewable

High Cholesterol

3750.0 mg, , 625.0 mg, 1875.0 mg

, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Bar, chewable - Oral, Bar, chewable

Diet

3750.0 mg, , 625.0 mg, 1875.0 mg

, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Bar, chewable - Oral, Bar, chewable

Hypercholesterolemia

3750.0 mg, , 625.0 mg, 1875.0 mg

, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Bar, chewable - Oral, Bar, chewable

Hyperlipidemia

3750.0 mg, , 625.0 mg, 1875.0 mg

, Oral, For suspension, For suspension - Oral, Tablet, film coated, Tablet, film coated - Oral, Powder, for suspension, Powder, for suspension - Oral, Tablet, Tablet - Oral, Tablet, coated - Oral, Tablet, coated, Bar, chewable - Oral, Bar, chewable

Warnings

There are 20 known major drug interactions with Colesevelam Hydrochloride.

Common Colesevelam Hydrochloride Drug Interactions

Drug Name

Risk Level

Description

Mycophenolate mofetil

Major

Colesevelam can cause a decrease in the absorption of Mycophenolate mofetil resulting in a reduced serum concentration and potentially a decrease in efficacy.

Mycophenolic acid

Major

Colesevelam can cause a decrease in the absorption of Mycophenolic acid resulting in a reduced serum concentration and potentially a decrease in efficacy.

Raloxifene

Major

Colesevelam can cause a decrease in the absorption of Raloxifene resulting in a reduced serum concentration and potentially a decrease in efficacy.

(R)-warfarin

Minor

Colesevelam can cause a decrease in the absorption of (R)-warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.

(S)-Warfarin

Minor

Colesevelam can cause a decrease in the absorption of (S)-Warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.

Colesevelam Hydrochloride Toxicity & Overdose Risk

Taking too much colesevelam may cause eye irritation, constipation, abdominal cramps, nausea, vomiting, and/or diarrhea. It is unlikely to cause serious systemic toxicity, since it does not get absorbed into the body. Taking more than 4.5 grams per day has not been tested.

image of a doctor in a lab doing drug, clinical research

Colesevelam Hydrochloride Novel Uses: Which Conditions Have a Clinical Trial Featuring Colesevelam Hydrochloride?

184 active studies are assessing the potential of Colesevelam Hydrochloride for treating Hyperlipidemia, Type 2 Diabetes and Hypercholesterolemia.

Condition

Clinical Trials

Trial Phases

Hyperlipidemia

0 Actively Recruiting

High Cholesterol

15 Actively Recruiting

Phase 2, Phase 3, Not Applicable, Early Phase 1

Diet

5 Actively Recruiting

Not Applicable, Phase 1

Physical Activity

30 Actively Recruiting

Not Applicable, Phase 2

Hypercholesterolemia

4 Actively Recruiting

Phase 1, Phase 3

Type 2 Diabetes

184 Actively Recruiting

Not Applicable, Phase 2, Phase 4, Phase 1, Early Phase 1, Phase 3

Colesevelam Hydrochloride Reviews: What are patients saying about Colesevelam Hydrochloride?

4.3

Patient Review

8/16/2010

Colesevelam Hydrochloride for Additional Medication for Diabetes Type 2

4

Patient Review

10/21/2010

Colesevelam Hydrochloride for High Cholesterol

So far, this has been working well for me. I've taken it orally before and had to stop because of heat-related issues; however, the replacement medications all had such terrible side effects that I asked to be put back on this one.

4

Patient Review

4/8/2022

Colesevelam Hydrochloride for Heterozygous Inherited High Blood Cholesterol

I've been on this cholesterol medication for decades, and it's helped reduce my LDL by about 25%. It works in the digestive tract to remove fats without entering the bloodstream. I use the powder form because the pills are so large, which dissolves well if you use a shaker cup. I find that adding cherry juice helps with the taste.

4

Patient Review

4/28/2020

Colesevelam Hydrochloride for High Cholesterol

I've been using this product for a few years now and have generally been pleased. However, the recent change in manufacturers has resulted in a thinner, stickier product that I'm not as fond of. I contacted the Federal Drug Administration about it.

3.7

Patient Review

2/10/2011

Colesevelam Hydrochloride for High Cholesterol

I've found that this medication prevents my body from absorbing levothyroxine, which is something most doctors are unaware of. I'm currently taking the levothyroxine four hours before the first dose of welchol to see how it works.

3.3

Patient Review

7/28/2022

Colesevelam Hydrochloride for High Cholesterol

I can use Colesevelam for a few weeks before I start to experience negative side effects like depression and insomnia. Once I stop taking the medication, those problems go away too.

1

Patient Review

1/13/2013

Colesevelam Hydrochloride for High Cholesterol

I took the first three pills and then one hour later had a severe headache (migraine), light sensitivity, and extreme abdominal bloating. I also had a severe hemmroidal flare up with constipation and rectal bleeding. Dizziness made it all worse. It took me three days to recover from these effects, and this was only after taking half of the recommended dose.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about colesevelam hydrochloride

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is colesevelam hydrochloride used to treat?

"Colesevelam is a medication used to lower high cholesterol and blood sugar levels. It is often used in conjunction with diet and exercise to prevent medical problems associated with high cholesterol and blood sugar levels."

Answered by AI

What are side effects of colesevelam?

"What are the side effects of gas-x? They can include constipation, nausea, vomiting, diarrhea, heartburn, stomach or back pain, and headaches."

Answered by AI

Is colesevelam HCl a statin?

"Welchol is a drug that lowers bad cholesterol in a different way from statins. Statins work in the liver, while Welchol works in the intestines. Welchol is a "bile acid sequestrant" that is indicated to lower LDL or "bad" cholesterol."

Answered by AI

Does colesevelam stop diarrhea?

"In a 2009 study, 45 people with cancer and symptoms of bile acid malabsorption were given colesevelam. After 3 months, they experienced improvements in diarrhea, frequency and urgency of defecation, steatorrhoea, abdominal pain, and faecal incontinence."

Answered by AI

Clinical Trials for Colesevelam Hydrochloride

Image of Caridad Center, Inc. in Boynton Beach, United States.

CHW Nutrition Support for Type 2 Diabetes

18+
All Sexes
Boynton Beach, FL

This study tests whether adding CHW support to usual nutrition care helps adults with type 2 diabetes, hypertension, or chronic kidney disease manage their diet and health. At Caridad Center, a free clinic in Palm Beach County, Florida, usual care includes medical nutrition therapy from a registered dietitian and medically tailored groceries. Many patients find it hard to keep up dietary changes because of limited nutrition knowledge, cooking skills, food costs, and cultural fit. Two hundred adults will be randomly assigned to usual care or usual care plus INTEGRATE-CHW, a 12-week program of six sessions with a trained CHW. In each session the participant selects one or two goals from the dietitian's plan and builds an action plan with the CHW. The dietitian remains responsible for the nutrition plan. The study will compare nutrition self-efficacy, nutrition literacy, diet quality, food security, and clinical measures between groups at baseline and Week 12. It will also evaluate how well the program fits into routine clinic care.

Waitlist Available
Has No Placebo

Caridad Center, Inc.

Janet Diaz Martinez

Image of McMaster University in Hamilton, Canada.

Exercise for Gender Differences in BDNF Levels

18 - 35
All Sexes
Hamilton, Canada

A single bout of exercise can improve cognitive abilities like memory and attention. These functions help us navigate through everyday life. However, we do not fully understand how exercise improves cognitive abilities. We believe that exercise improves the brain by increasing the amount of BDNF in the blood. BDNF is very important for learning and memory. However, we still do not know if BDNF responds differently to exercise between females and males. The purpose of this work is to characterize potential sex-differences in the circulating BDNF response to acute exercise. We will test the hypothesis that males will have greater serum and plasma BDNF responses compared to females following a maximal exercise test.

Recruiting
Has No Placebo

McMaster University

Jeremy J Walsh, PhD

Image of Kaiser Permenante Division of Research in Pleasanton, United States.

EHR Alerts for Metabolic Syndrome

18+
All Sexes
Pleasanton, CA

SWAP-CKM (SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome) is a pragmatic, cluster-randomized clinical trial designed to evaluate whether electronic health record (EHR)-based alerts can improve medication prescribing among adults with cardiovascular, kidney, and metabolic (CKM) conditions. The study will include all eligible adult patients receiving care within Kaiser Permanente Northern California (KPNC) who have CKM conditions and opportunities for therapeutic medication substitution. Fifteen service areas are randomly assigned to either an intervention group or a usual care group. Clinicians in the intervention group will receive EHR-based Best Practice Advisories (BPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The intervention may also include audit-and-feedback reports to support medication optimization. Clinicians retain full discretion over treatment decisions. The primary outcome is the proportion of eligible therapeutic optimization opportunities achieved at 9 months. Secondary outcomes include medication initiation and discontinuation, medication optimization at 18 months, and polypharmacy burden.

Waitlist Available
Has No Placebo

Kaiser Permenante Division of Research

Ankeet S Bhatt, MD, MBA, ScM

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Image of University of Cincinnati Medical Center in Cincinnati, United States.

Continuous Glucose Monitoring for Type 2 Diabetes

18+
All Sexes
Cincinnati, OH

The TRANSITION-CGM trial will evaluate whether starting continuous glucose monitoring (CGM) before hospital discharge improves blood glucose control in adults with type 2 diabetes compared with usual care using finger-stick blood glucose checks. The study focuses on the transition from hospital to home, when patients may face changes in diabetes medications and challenges managing their blood glucose levels. This single-center, randomized controlled trial will enroll approximately 218 adults with type 2 diabetes, a hemoglobin A1c (HbA1c) 9% and above, and treatment with insulin and/or oral diabetes medications. Participants will be recruited during hospitalization and must be expected to return home after discharge. People already using a CGM will not be eligible. Participants will be randomly assigned in equal numbers to one of two groups. The CGM group will start using a continuous glucose monitor before discharge and receive device training and written instructions. The usual-care group will continue finger-stick blood glucose monitoring and receive standard discharge education. Both groups will receive assistance with outpatient diabetes follow-up. Diabetes medications will be managed by treating clinicians according to usual clinical practice. Participants will be followed for approximately 12 weeks after discharge, with an early follow-up encounter and a final assessment at 12 weeks. The primary outcome is HbA1c at 12 weeks, a blood test that reflects average blood glucose levels over approximately three months. Secondary outcomes include diabetes-related hospitalizations and episodes of low blood sugar. Additional exploratory measures include CGM use, follow-up attendance, patient-reported experiences, and time spent within the target glucose range when CGM data are available. The study will determine whether initiating CGM during hospitalization can improve glycemic control after discharge and provide preliminary evidence about its effects on diabetes-related hospitalizations and hypoglycemia.

Waitlist Available
Has No Placebo

University of Cincinnati Medical Center

Arunab H Mehta, MD, MEd

Image of Weill Cornell Medicine in New York, United States.

Coronary Artery Calcium Testing for Cardiovascular Disease

18+
All Sexes
New York, NY

The goal of this study is to improve how primary care providers identify and manage patients at risk for heart disease. One tool that can help with this is a coronary artery calcium (CAC) test, which looks for calcium buildup in the heart's arteries and can help estimate a person's risk of future heart problems. The main questions this study aims to answer are: Will a new electronic health record (EHR) alert that provides guidance on when to consider a CAC test be feasible and acceptable to primary care providers? Does the alert change how often providers order CAC tests, start or change the dose of cholesterol-lowering medications, and refer patients to cardiology? In this study, a new EHR alert will be implemented as part of routine clinical practice for primary care providers at Weill Cornell Internal Medicine Associates (WCIMA). The alert will provide guidance on considering a CAC test, cholesterol-lowering medication, or referral to cardiology for eligible patients. Researchers will compare clinical care before and after the alert is implemented. They will look at how often CAC tests are ordered and completed, how often cholesterol-lowering medications are started or their doses are changed, and how often patients are referred to cardiology. After the implementation period, primary care providers will also be asked to complete a brief survey and participate in an interview about the alert.

Waitlist Available
Has No Placebo

Weill Cornell Medicine

Madeline R Sterling, MD, MPH

Merck Sharp & Dohme LLC

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Financial Counseling and Health Reviews for Chronic Illness Management

18+
All Sexes
Philadelphia, PA

Among adults with chronic illnesses like hypertension, diabetes, or HIV, adherence to daily oral medications is essential but often below 50%. Why do medication adherence and preventive health service engagement remain stubbornly low? Scarcity theory offers a novel explanation in the context of poverty. It posits that economic hardship imposes a cognitive burden that shifts attention from long-term goals to immediate needs, reduces future orientation (the relative value placed on immediate vs. future outcomes), and limits mental bandwidth (the cognitive resources needed for decisions), thus undermining behaviors like daily medication adherence and service engagement. To address these gaps, the study's objective is to rigorously test whether and how economic scarcity affects medication adherence and preventive service uptake among older adults with chronic disease, leveraging the naturally occurring monthly fluctuation in scarcity created by the Supplemental Nutrition Assistance Program (SNAP) benefit cycle as a natural experiment. There are three aims: 1. Daily medication adherence will be measured objectively for four months with wireless electronic pill bottle caps (CleverCaps). The investigators will test whether, when, and by how much adherence changes as scarcity fluctuates during the SNAP benefit cycle. 2. The investigators will conduct two easily implementable RCTs to test whether scarcity affects participants' engagement with beneficial services requiring navigation of administrative burdens. In one trial, participants will be randomized to receive an invitation during either a high- or low- scarcity period (i.e., before vs. after SNAP receipt) to a personalized preventive health review that identifies gaps in US Preventive Services Task Force Grade A/B recommendations. In the second, participants will be invited to free financial counseling provided by the City of Philadelphia during a high- or low-scarcity period. The investigators hypothesize invitation response rates will be \>15% higher during low-scarcity periods. 3. Potential mechanisms that link scarcity with health behaviors will be examined by randomizing timing of validated measures of mental bandwidth and future orientation during a period of high- or low-scarcity (i.e., before vs. after SNAP receipt). The investigators hypothesize that there will be differences in several measures between participants who are randomly assessed during high- vs. low-scarcity periods (i.e. before vs. after SNAP receipt). Impact: Demonstrating that scarcity helps to explain low medication adherence and beneficial health-related service uptake can inform patient-centered adherence interventions, clinical care-delivery approaches, health-system strategies, and public health approaches to improve these health behaviors and promote healthy aging.

Waitlist Available
Has No Placebo

Penn Medicine, 3535 Market St.

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