CLINICAL TRIALS PROFILE FOR QUESTRAN LIGHT

All Clinical Trials for Questran Light

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.

Clinical Trial Conditions for Questran Light

Condition Name

Condition Name for Questran Light
Intervention	Trials
DIABETES	2
Healthy	2
Orphan Cholestatic Liver Diseases	1

Condition MeSH

Condition MeSH for Questran Light
Intervention	Trials
Liver Cirrhosis, Biliary	1
Smoldering Multiple Myeloma	1
Carotid Stenosis	1

Clinical Trial Locations for Questran Light

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Questran Light

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Questran Light

Sponsor Name

Sponsor Name for Questran Light
Sponsor	Trials
National Cancer Institute (NCI)	2
City of Hope Medical Center	2
Daiichi Sankyo Inc.	2

Sponsor Type

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

Questran Light: Clinical Trials, Market Analysis, and Projections

Introduction to Questran Light

Questran Light, a formulation of cholestyramine, is a bile acid sequestrant used primarily to treat hypercholesterolemia. It works by binding to bile acids in the intestine, which are then excreted, reducing the amount of cholesterol produced in the liver.

Clinical Trials Overview

Efficacy Comparison of Questran Light

A clinical study compared the efficacy of Questran Light, a new low-calorie cholestyramine formulation, with the currently marketed Questran formulation. The study involved 61 men with hypercholesterolemia, who were randomized into two groups: one receiving the new Questran Light formulation and the other continuing with the marketed Questran formulation. Both groups consumed 24 grams of cholestyramine per day in two divided doses.

The results showed that there were no statistically significant mean changes in lipid/lipoprotein levels from baseline to endpoint within either group, nor were there any significant differences between the two groups. This indicates that the new low-calorie Questran Light formulation is equally effective in maintaining lowered plasma cholesterol levels as the currently marketed formulation[2].

Market Analysis

Current Market Size and Growth

The cholestyramine market, which includes Questran Light, was estimated to be USD 186.60 million in 2023 and is expected to reach USD 196.08 million in 2024, growing at a Compound Annual Growth Rate (CAGR) of 5.42% to reach USD 270.03 million by 2030[5].

Market Drivers

• Increasing Awareness and Diagnosis: Growing awareness and diagnosis of hypercholesterolemia, particularly in developing regions, are driving the demand for cholestyramine-based treatments like Questran Light.
• Healthcare Expenditure and Government Initiatives: Increased healthcare expenditure and government initiatives aimed at reducing cardiovascular risks also contribute to the market growth.
• Prevalence of Cardiovascular Diseases: The growing prevalence of cardiovascular diseases among adults and the aging population further boosts the market[5].

Market Restraints

• Patient Habits and Preferences: Slowly evolving patient habits and preferences can hinder the uptake of cholestyramine.
• Regulatory Challenges: Regulatory challenges and compliance issues can slow down market expansion.
• Limited Awareness Among Healthcare Professionals: Limited awareness among healthcare professionals about the benefits of cholestyramine can also restrain market growth[5].

Market Opportunities

• Digital Marketing Campaigns: There is an opportunity to enhance patient awareness of cholestyramine benefits through digital marketing campaigns.
• Alternative Therapy for Statin-Intolerant Populations: Cholestyramine, including Questran Light, can serve as an alternative therapy for populations intolerant to statins.
• Nutraceuticals Market: There is potential growth for cholestyramine in the nutraceuticals market as a fiber supplement alternative[5].

Market Challenges

• Supply Chain Operations: Achieving sustainable supply chain operations for cholestyramine amidst global disruptions is a significant challenge.
• Distribution and Accessibility: Hurdles in the distribution and accessibility of cholestyramine products can impact market growth[5].

Competitive Landscape

Questran Light competes with other lipid-lowering medications such as fenofibrate and atorvastatin. Here is a brief comparison:

• Questran Light: Available as an oral powder for reconstitution, it has a positive rating from 71% of reviewers on Drugs.com[4].
• Fenofibrate: Available in oral capsule and tablet forms, it has a lower positive rating of 44% from reviewers on Drugs.com[4].
• Atorvastatin: Available as an oral tablet, it has the lowest positive rating of 29% from reviewers on Drugs.com[4].

Product Development and Innovation

The cholestyramine market, including Questran Light, is seeing innovations in product forms and applications. For instance, the market is exploring new product types such as granules and pellets, in addition to the traditional powder form. There is also a focus on expanding applications beyond hyperlipidemia treatment to include bile acid sequestration and potential uses in the nutraceuticals market[5].

Regulatory and Clinical Considerations

Clinical trials and regulatory approvals are crucial for the continued use and development of Questran Light. For example, the European Medicines Agency (EMA) has strict guidelines for clinical trials, including those for bile acid sequestrants, ensuring that products meet safety and efficacy standards before they are approved for market use[3].

Key Takeaways

• Efficacy: Questran Light is equally effective as the currently marketed Questran formulation in maintaining lowered plasma cholesterol levels.
• Market Growth: The cholestyramine market is expected to grow at a CAGR of 5.42% to reach USD 270.03 million by 2030.
• Market Drivers: Increasing awareness, healthcare expenditure, and government initiatives drive the market.
• Challenges: Regulatory challenges, patient habits, and supply chain disruptions are key challenges.
• Competitive Landscape: Questran Light competes with other lipid-lowering medications but has a higher positive rating from users.

FAQs

What is Questran Light used for?

Questran Light is used to treat hypercholesterolemia by binding to bile acids in the intestine, which are then excreted, reducing the amount of cholesterol produced in the liver.

How does Questran Light compare to other lipid-lowering medications?

Questran Light has a higher positive rating from users compared to fenofibrate and atorvastatin, although it is available in a different form (oral powder for reconstitution).

What are the market drivers for Questran Light?

The market drivers include increasing awareness and diagnosis of hypercholesterolemia, increased healthcare expenditure, and government initiatives to reduce cardiovascular risks.

What are the challenges facing the Questran Light market?

Challenges include regulatory compliance issues, slowly evolving patient habits and preferences, and hurdles in supply chain operations.

What are the potential future applications of Questran Light?

Future applications could include use in the nutraceuticals market as a fiber supplement alternative and as an alternative therapy for statin-intolerant populations.

Sources

1. EU Clinical Trials Register: EudraCT Number 2016-003486-26 - Clinical trial results.
2. PubMed: Comparison of the efficacy of Questran Light, a new low-calorie cholestyramine formulation.
3. European Medicines Agency: Bylvay - Assessment report.
4. Drugs.com: Questran Light Alternatives Compared.
5. 360 Research Reports: Cholestyramine Market Size & Share 2025-2030.