CLINICAL TRIALS PROFILE FOR QUESTRAN

All Clinical Trials for Questran

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01053065 ↗	The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study	Completed	Biomedical Foundation for Cardiovascular Research of Padova	N/A	1969-12-31	The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins. The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.
NCT01053065 ↗	The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study	Completed	Pfizer	N/A	1969-12-31	The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins. The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.
NCT01053065 ↗	The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study	Completed	University of Padova	N/A	1969-12-31	The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins. The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.
NCT01053065 ↗	The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study	Completed	University of Padua	N/A	1969-12-31	The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins. The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.
NCT01062269 ↗	A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study	Completed	Daiichi Sankyo Inc.	Phase 4	2010-01-01	The purpose of the research study is (1) to rate the taste, texture, appearance, and mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating cholestyramine and Tang to determine the accuracy and usefulness of a taste test questionnaire.

Clinical Trial Conditions for Questran

Condition Name

Condition Name for Questran
Intervention	Trials
DIABETES	2
Healthy	2
Indication for Carotid Endarterectomy	1
Alagille Syndrome	1

Condition MeSH

Condition MeSH for Questran
Intervention	Trials
Graves Disease	1
Hematologic Neoplasms	1
Diabetic Neuropathies	1
Liver Diseases	1

Clinical Trial Locations for Questran

Trials by Country

Trials by Country for Questran
Location	Trials
United States	6
Malaysia	3
Chile	2
France	1
Italy	1

Trials by US State

Trials by US State for Questran
Location	Trials
California	2
Kentucky	2
North Carolina	1
Michigan	1

Clinical Trial Progress for Questran

Clinical Trial Phase

Clinical Trial Phase for Questran
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Questran
Clinical Trial Phase	Trials
Completed	5
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for Questran

Sponsor Name

Sponsor Name for Questran
Sponsor	Trials
Louisville Metabolic and Atherosclerosis Research Center	2
National Cancer Institute (NCI)	2
City of Hope Medical Center	2

Sponsor Type

Sponsor Type for Questran
Sponsor	Trials
Other	14
Industry	6
NIH	2

Questran Light: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

What is Questran Light?

Questran Light, known generically as cholestyramine, is a bile acid sequestrant used to lower cholesterol levels and treat various conditions related to bile acid imbalances. It works by binding to bile acids in the intestines, forming an insoluble complex that is eliminated in the feces, thereby reducing the reabsorption of bile acids into the bloodstream[1].

Clinical Trials Update

Ongoing Studies

There are several active clinical trials assessing the potential of Questran Light for various conditions. Here are some key areas of focus:

• Primary Hypercholesterolemia: Twelve active studies are recruiting patients to evaluate the efficacy of Questran Light in managing primary hypercholesterolemia, with trial phases ranging from Phase 2 to Phase 3[1].
• Itching (Pruritus): Four active studies are investigating the use of Questran Light to alleviate itching associated with cholestatic liver diseases, also across various trial phases[1].
• Partial Biliary Obstruction: Although there are no actively recruiting trials specifically for partial biliary obstruction, ongoing research includes this condition as part of broader studies on bile acid-related disorders[1].
• Hardening of the Arteries: Twenty-three active studies are examining the role of Questran Light in managing hardening of the arteries (atherosclerosis), with trial phases including Phase 1, Phase 2, Phase 3, and Phase 4[1].

Historical Evidence

Previous studies have shown promising results for cholestyramine in retarding the progression of coronary artery disease (CAD) in patients with Type II hyperlipoproteinemia. The NHLBI Type II Coronary Intervention Study demonstrated that cholestyramine treatment significantly reduced the progression of CAD compared to placebo, highlighting its potential in cardiovascular health management[4].

Market Analysis

Current Market Size and Growth

The cholestyramine market, which includes Questran Light, was valued at USD 186.60 million in 2023 and is expected to reach USD 196.08 million in 2024. The market is projected to grow at a CAGR of 5.42%, reaching USD 270.03 million by 2030[2].

Key Drivers

The growth of the cholestyramine market is driven by several factors:

• Increasing Prevalence of Heart Disease: The rising incidence of heart disease and other cholesterol-related conditions necessitates effective lipid-lowering treatments, contributing to the demand for cholestyramine[2].
• Advancements in Drug Formulations: Innovations in drug formulations and delivery methods are enhancing patient compliance and efficacy, further boosting market growth[2].
• Growing Geriatric Population: The increasing geriatric population, which is more prone to hyperlipidemia, is another significant driver of the market[2].

Market Challenges

Despite the growth potential, the market faces several challenges:

• Competition from Newer Agents: The availability of newer lipid-lowering agents, such as statins, poses a significant competitive threat to cholestyramine[2].
• Regulatory Hurdles and Side Effects: Regulatory challenges and the side effects associated with cholestyramine, such as gastrointestinal discomfort, also hinder market growth[2].

Geographic and Sectoral Analysis

The North American region is expected to hold a significant share of the bile acid sequestrants market, including cholestyramine, due to its high usage in treating pruritus in liver cirrhosis patients. European markets are also anticipated to expand rapidly, driven by the development of novel drugs and increasing clinical trials[5].

Market Projections

Future Growth Opportunities

To maintain competitiveness and foster growth, the cholestyramine market needs to address current limitations and tap into untapped geographical regions and patient needs. Here are some key strategies:

• Expanding Applications: Research into new applications, such as emerging markets where the incidence of cholesterol-related diseases is increasing but treatment accessibility remains limited, can drive future growth[2].
• Innovation in Formulations: Developing formulations with improved patient compliance and reduced side effects is crucial. This could include new delivery methods or combinations with other therapies[2].
• Strategic Market Expansions: Enhancing distribution channels, adapting pricing strategies, and investing in outreach and education programs can help penetrate growing markets[2].

Patient and Clinical Perspectives

Effectiveness and Side Effects

Cholestyramine is effective in lowering cholesterol levels and alleviating pruritus symptoms in patients with cholestatic liver diseases. However, it can cause side effects such as constipation, stomach pain, gas, nausea, and vomiting. Patients are advised to take the medication as prescribed, usually before meals or at bedtime, and to avoid taking other medications within a certain time frame to prevent interference with absorption[1].

Patient Reviews and Q&A

Patients have reported mixed experiences with Questran Light. While it is effective in managing cholesterol and pruritus, some patients have noted gastrointestinal side effects. It is essential for patients to follow the prescribed dosage and consult their healthcare provider if they experience any adverse effects[1].

Key Takeaways

• Clinical Trials: Questran Light is being actively studied for its efficacy in managing primary hypercholesterolemia, itching, and hardening of the arteries.
• Market Growth: The cholestyramine market is expected to grow at a CAGR of 5.42% until 2030, driven by increasing prevalence of heart disease and advancements in drug formulations.
• Challenges: The market faces competition from newer lipid-lowering agents and regulatory hurdles, along with side effects associated with the drug.
• Future Strategies: Innovations in formulations, expanding applications, and strategic market expansions are crucial for maintaining competitiveness.

FAQs

What is Questran Light used for?

Questran Light is used to lower cholesterol levels, reduce the risk of heart disease, and alleviate itching associated with cholestatic liver diseases by binding to bile acids in the intestines and preventing their reabsorption[1].

What are the common side effects of Questran Light?

Common side effects include constipation, stomach/abdominal pain, gas, nausea, and vomiting. Patients should report any of these effects to their doctor or pharmacist[1].

How should I take Questran Light?

The medication should be taken as prescribed by your doctor, usually before meals or at bedtime. Other medications should be taken at least 1 hour before or 4 hours after taking cholestyramine to avoid interference with absorption[1].

Can Questran Light interact with other medications?

Yes, Questran Light can interact with several medications, including Mycophenolate mofetil, Mycophenolic acid, Raloxifene, and Warfarin, potentially reducing their efficacy. It is important to inform your healthcare provider about all medications you are taking[1].

What are the potential risks of overdosing on Questran Light?

Overdosing on Questran Light can lead to an obstruction in the stomach or intestines, highlighting the importance of adhering to the prescribed dosage[1].

Sources

1. Questran Light: Everything you need to know - Power - Clinical Trials
2. Cholestyramine Market by Grade, Purity, End Use, Application - 360iResearch
3. Progressive Familial Intrahepatic Cholestasis Type 2 Treatment Market - BioSpace
4. Results of the NHLBI Type II Coronary Intervention Study - PubMed
5. Bile Acid Sequestrants Market Size & Share | Growth Report 2037 - Research Nester