Side Effects of colesevelam: A Synthesis of Findings from 17 Studies

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Original Abstract of the Article

Main Research Findings

Colesevelam is a bile acid sequestrant that has been shown to be effective in lowering cholesterol. 13 demonstrated that coadministration of colesevelam and atorvastatin effectively lowers LDL cholesterol. 14 showed that combination therapy with colesevelam and lovastatin is effective in lowering LDL cholesterol. 15 demonstrated that coadministration of colesevelam and simvastatin effectively lowers LDL cholesterol. On the other hand, 4 showed that colesevelam is not effective in the treatment of cholestatic pruritus. Colesevelam is considered to have fewer side effects than conventional bile acid sequestrants. 17 showed that colesevelam has fewer gastrointestinal side effects than conventional bile acid sequestrants. 6 indicated that colesevelam is preferred over other bile acid sequestrants due to its fewer gastrointestinal side effects. Colesevelam is not only used for the treatment of dyslipidemia but is also considered to be effective in the treatment of diabetes. 5 demonstrated that colesevelam is effective in improving blood glucose levels in patients with diabetes.

Reasons for Side Effects

The side effects of colesevelam are mainly thought to be due to its bile acid-binding action. Bile acids are a type of digestive fluid that helps digest and absorb fats. Colesevelam binds to bile acids, inhibiting their absorption in the intestine and promoting their excretion from the body. Therefore, gastrointestinal symptoms have been reported as side effects of colesevelam.

Common Side Effects

Constipation

Colesevelam can cause constipation because it keeps bile acids in the intestines. 13 mentions side effects such as constipation. Constipation is one of the common side effects of colesevelam, and patients need to take measures to prevent constipation. 6 states that compared to conventional bile acid sequestrants, colesevelam has fewer gastrointestinal side effects such as constipation, leading to higher patient compliance.

Maldigestion

Colesevelam can cause maldigestion because it inhibits the absorption of bile acids. 1 states that maldigestion can occur because colesevelam inhibits the absorption of certain vitamins and minerals.

Abdominal Distention

Colesevelam can cause abdominal distention because it expands in the intestines. 1 states that abdominal distention can occur because colesevelam affects the gastrointestinal tract.

Diarrhea

Colesevelam can cause diarrhea because it inhibits the absorption of bile acids. 1 states that diarrhea can occur because colesevelam affects the gastrointestinal tract.

Countermeasures for Side Effects

Constipation

Measures to prevent constipation include drinking plenty of water and eating foods rich in dietary fiber. 13 mentions side effects such as constipation. Constipation is one of the common side effects of colesevelam, and patients need to take measures to prevent constipation.

Maldigestion

Measures to prevent maldigestion include eating small meals, chewing food thoroughly, and consuming easily digestible foods. 1 states that maldigestion can occur because colesevelam inhibits the absorption of certain vitamins and minerals.

Abdominal Distention

Measures to prevent abdominal distention include reducing meal portions and chewing food thoroughly. 1 states that abdominal distention can occur because colesevelam affects the gastrointestinal tract.

Diarrhea

Measures to prevent diarrhea include drinking plenty of fluids and taking antidiarrheal medications. 1 states that diarrhea can occur because colesevelam affects the gastrointestinal tract.

Comparison Between Studies

Commonalities of Studies

Many studies have shown that colesevelam is effective in lowering LDL cholesterol. 13 , 14 , 15 showed that coadministration of colesevelam with other lipid-lowering agents effectively lowers LDL cholesterol.

Differences Between Studies

The results of studies on the side effects of colesevelam vary. 17 showed that colesevelam has fewer gastrointestinal side effects than conventional bile acid sequestrants, whereas 1 suggests that colesevelam can cause gastrointestinal side effects.

Notes on Application to Daily Life

Although colesevelam has been shown to be effective in lowering LDL cholesterol, it is necessary to consider the risk of side effects. 1 states that colesevelam can cause gastrointestinal side effects. It is important to consult with a doctor before taking colesevelam and follow the correct dosage instructions.

Limitations of Current Research

There is still insufficient data on the long-term safety of colesevelam. 5 showed that colesevelam is effective in improving blood glucose levels in patients with diabetes, but further research is needed on its long-term safety.

Future Research Directions

Research is needed to evaluate the long-term safety and efficacy of colesevelam. Research on reducing the side effects of colesevelam is also needed.

Conclusion

Colesevelam has been shown to be effective in lowering LDL cholesterol, and it is considered to have fewer side effects than conventional bile acid sequestrants. 17 , 6 showed that colesevelam has fewer gastrointestinal side effects than conventional bile acid sequestrants. It is important to consult with a doctor before taking colesevelam and follow the correct dosage instructions.

Literature analysis of 17 papers
Positive Content
16
Neutral Content
0
Negative Content
1
Article Type
6
0
1
10
17
1.

Gastrointestinal tract as a side-effect target of medications.

Author: Domagała-RodackaRenata, CiborDorota, SzczeklikKatarzyna, RodackiTomasz, MachTomasz, OwczarekDanuta

Adverse drug reaction

Adverse drug reactions (ADRs) are a common problem in medicine. About 10% of ADRs involve the gastrointestinal system. ADRs can affect all parts of the digestive system, from the mouth to the intestines. It is important for doctors to be aware of these potential problems so they can prevent them.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

2.

<sup>75</sup>SeHCAT scan in bile acid malabsorption in chronic diarrhoea.

Author: Mena BaresL M, Carmona AsenjoE, García SánchezM V, Moreno OrtegaE, Maza MuretF R, Guiote MorenoM V, Santos BuenoA M, Iglesias FloresE, Benítez CanteroJ M, Vallejo CasasJ A

Diarrhea treatment

Bile acid malabsorption (BAM) is a condition that causes chronic diarrhea. This study discusses the diagnosis and treatment of BAM.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Systematic review: the management of chronic diarrhoea due to bile acid malabsorption.

Author: WilcoxC, TurnerJ, GreenJ

BAM treatment
Improved symptoms
Poor tolerability
Reduced bioavailability of other drugs

Colestyramine and colestipol are generally effective treatments for gastrointestinal symptoms from bile acid malabsorption (BAM), but they may be poorly tolerated and reduce the bioavailability of co-administered agents. Alternative therapies, including colesevelam and aluminium hydroxide, as well as dietary intervention may also have a role.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

4.

The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: results of a double-blind, randomized, placebo-controlled trial.

Author: KuiperEdith M M, van ErpecumKarel J, BeuersUlrich, HansenBettina E, ThioH Bing, de ManRobert A, JanssenHarry L A, van BuurenHenk R

Cholestatic pruritus treatment
Side effects

Colesevelam, an anion-exchange resin, was compared to placebo in patients with cholestatic pruritus. While colesevelam significantly reduced serum bile acid levels, there was no significant difference in pruritus scores, quality of life scores, or severity of scratch lesions between the two groups. Mild side effects were observed in one colesevelam-treated patient and four placebo-treated patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

5.

Long-term Safety and Tolerability of Colesevelam HCl in Subjects with Type 2 Diabetes.

Author: GoldfineA B, FonsecaV A, JonesM R, WangA C, FordD M, TruittK E

Glycemic Control
Type 2 Diabetes Treatment
Constipation
Dyspepsia
Hypoglycemia

Colesevelam hydrochloride, a bile acid sequestrant, was safe and well-tolerated for long-term use in patients with type 2 diabetes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

The use of colesevelam hydrochloride in the treatment of dyslipidemia: a review.

Author: DavidsonMichael H

Dyslipidemia treatment
LDL-C reduction
Gastrointestinal side effects

Colesevelam hydrochloride is a non-absorbed lipid-lowering agent used to reduce LDL-C in patients with primary hypercholesterolemia. It is preferred over other bile-acid sequestrants due to fewer gastrointestinal side effects and can be used as monotherapy or in combination with other cholesterol-lowering drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Colesevelam hydrochloride in the management of dyslipidemia.

Author: ArmaniAnnemarie, TothPeter P

Dyslipidemia treatment

This article summarizes the pharmacology, clinical efficacy, and safety of colesevelam hydrochloride, a bile acid-binding resin used in the management of dyslipidemia. Colesevelam significantly impacts serum levels of lipoproteins when used as monotherapy or in combination with statins or ezetimibe.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Colesevelam: potential uses for the newest bile resin.

Author: SteinmetzKaren L, SchonderKristine S

Dose sparing effect on statins
Reduced LDL-C levels
Gastrointestinal side effects

Colesevelam, a new bile resin, is safe and effective in lowering LDL-C levels alone or in combination with statins. It may be particularly useful in patients who cannot tolerate other lipid-lowering therapies.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Hypolipidemic therapy and cholesterol absorption.

Author: ManhasAmit, FarmerJohn A

Improved lipid profile
Reduced LDL cholesterol
Liver toxicity
Rhabdomyolysis

This review focuses on pharmacologic agents that reduce cholesterol absorption, such as colesevelam and ezetimibe. These agents can be used alone or in combination with statins to optimize lipid profiles in patients with high cholesterol.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Overview of pharmacologic therapy for the treatment of dyslipidemia.

Author: LipsyRobert J

Improve compliance
Lower LDL

Statins are the most effective, widely prescribed, and best-tolerated lipid-lowering drugs. Ezetimibe, a selective cholesterol absorption inhibitor, can be used alone or in combination with statins to reduce LDL-C and improve patient compliance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

New drugs for the treatment of hypercholesterolaemia.

Author: IglesiasPedro, DíezJuan J

Improved lipid profiles
Reduced cholesterol levels

This review discusses the various lipid-lowering drugs used to reduce the risk of coronary heart disease. The review highlights two new statins, rosuvastatin and pitavastatin, which are more potent than other available statins and have a lower risk of muscle toxicity. The review also discusses the use of ezetimibe, a selective cholesterol absorption inhibitor, and colesevelam, a bile acid sequestrant.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Coadministration of colesevelam hydrochloride with atorvastatin lowers LDL cholesterol additively.

Author: HunninghakeD, InsullW, TothP, DavidsonD, DonovanJ M, BurkeS K

Hypercholesterolemia treatment

Colesevelam hydrochloride is a non-absorbed lipid-lowering agent. This study investigated the efficacy and safety of coadministering colesevelam and atorvastatin, a statin medication, in hypercholesterolemic patients. The combination therapy resulted in significant additive reductions in LDL cholesterol, similar to those achieved with the maximum atorvastatin dose. The coadministration was well-tolerated.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Low-dose combination therapy with colesevelam hydrochloride and lovastatin effectively decreases low-density lipoprotein cholesterol in patients with primary hypercholesterolemia.

Author: DavidsonM H, TothP, WeissS, McKenneyJ, HunninghakeD, IsaacsohnJ, DonovanJ M, BurkeS K

Hypercholesterolemia treatment
Lipid lowering

This multicenter, randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of combination low-dose colesevelam and lovastatin treatment in patients with primary hypercholesterolemia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Efficacy and safety of combination simvastatin and colesevelam in patients with primary hypercholesterolemia.

Author: KnappH H, SchrottH, MaP, KnoppR, ChinB, GazianoJ M, DonovanJ M, BurkeS K, DavidsonM H

Cholesterol reduction
Improved efficacy
Side effects

Coadministration of colesevelam and simvastatin was effective and well tolerated in patients with hypercholesterolemia. This combination provided additive reductions in LDL cholesterol levels compared with either agent alone.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Colesevelam hydrochloride: a non-absorbed, polymeric cholesterol-lowering agent.

Author: DavidsonM H, DicklinM R, MakiK C, KleinpellR M

Cholesterol lowering
Good tolerability
Minimal side effects

Colesevelam hydrochloride is a new cholesterol-lowering agent that has a non-systemic mechanism of action and minimal side effects. It is effective in reducing LDL-cholesterol levels and can be used alone or in combination with statins.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Colesevelam hydrochloride (cholestagel): a new, potent bile acid sequestrant associated with a low incidence of gastrointestinal side effects.

Author: DavidsonM H, DillonM A, GordonB, JonesP, SamuelsJ, WeissS, IsaacsohnJ, TothP, BurkeS K

Effective for hypercholesterolemia
Increased HDL cholesterol
Reduced LDL cholesterol
Well tolerated

Colesevelam hydrochloride was effective in lowering low-density lipoprotein cholesterol concentrations in people with moderate hypercholesterolemia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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