CLINICAL TRIALS PROFILE FOR NIASPAN

All Clinical Trials for Niaspan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00046267 ↗	Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to evaluate the safety, efficacy, and tolerability of extended-release niacin (Niaspan) in improving the level of fats in the blood of HIV-infected patients.
NCT00062556 ↗	Effect of Niacin ER/Lovastatin on Peak Walking Time & Claudication Onset Time in Patients With Intermittent Claudication	Completed	Kos Pharmaceuticals	Phase 3	2003-01-01	The purpose of this study is to evaluate if Niacin ER/Lovastatin, at two different doses, compared to diet control (this group will receive a tablet containing 50 mg. of immediate-release niacin) is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries, a condition called intermittent claudication. At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study. Niacin ER/Lovastatin is a combination of two FDA (United States Food and Drug Administration) approved cholesterol modifying medications: Niaspan® (extended-release niacin) and lovastatin, a statin (the same medicine found in Mevacor®). Niacin ER/Lovastatin was approved by the FDA under the name of Advicor® for use in the treatment of elevated cholesterol. The use of Niacin ER/Lovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational. An investigational use is one that is not approved by the FDA.
NCT00071266 ↗	The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC	Completed	Kos Pharmaceuticals	Phase 3	2003-10-01	The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries. At least 870 subjects, with leg pain caused by a narrowing of their leg arteries will take part in this study. Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Niacin ER/Lovastatin (Advicor®), a combination of these two drugs, is also approved by the FDA to treat high cholesterol. The use of Niacin ER/Lovastatin to treat narrowing of leg arteries and relieve "intermittent claudication" (leg pain caused by narrowing of the arteries in the leg) is considered investigational. An investigational use is one that is not approved by the FDA.
NCT00079638 ↗	Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL	Completed	Kos Pharmaceuticals	Phase 4	2004-04-01	The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.

Clinical Trial Conditions for Niaspan

Condition Name

Condition Name for Niaspan
Intervention	Trials
Dyslipidemia	9
Atherosclerosis	7
Coronary Artery Disease	4
Hypercholesterolemia	4

Condition MeSH

Condition MeSH for Niaspan
Intervention	Trials
Dyslipidemias	11
Coronary Artery Disease	8
Atherosclerosis	8
Myocardial Ischemia	7

Clinical Trial Locations for Niaspan

Trials by Country

Trials by Country for Niaspan
Location	Trials
United States	127
Canada	16
United Kingdom	2
France	2
Colombia	1

Trials by US State

Trials by US State for Niaspan
Location	Trials
Pennsylvania	11
California	9
Texas	7
Florida	7
North Carolina	6

Clinical Trial Progress for Niaspan

Clinical Trial Phase

Clinical Trial Phase for Niaspan
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	10
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Niaspan
Clinical Trial Phase	Trials
Completed	38
Unknown status	4
Terminated	3

Clinical Trial Sponsors for Niaspan

Sponsor Name

Sponsor Name for Niaspan
Sponsor	Trials
Merck Sharp & Dohme Corp.	8
Abbott	7
University of Pennsylvania	6

Sponsor Type

Sponsor Type for Niaspan
Sponsor	Trials
Other	35
Industry	34
NIH	10

NIASPAN: Clinical Trials, Market Analysis, and Projections

Introduction to NIASPAN

NIASPAN, an extended-release formulation of nicotinic acid (niacin or Vitamin B3), is a medication designed to manage lipid profiles and reduce the risk of cardiovascular diseases. Here, we will delve into the clinical trials, market analysis, and future projections for NIASPAN.

Clinical Trials and Efficacy

AIM-HIGH Trial

One of the significant clinical trials involving NIASPAN was the AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes) study. This trial, conducted by the NIH, was halted 18 months early due to the failure of NIASPAN to prevent heart attacks and strokes in patients with cardiovascular disease. Despite increasing HDL cholesterol and lowering triglycerides, the combination of NIASPAN with statins did not reduce the incidence of cardiovascular events[1].

Long-Term Efficacy and Safety

In contrast, long-term studies have shown that NIASPAN is safe and effective as monotherapy in regulating plasma lipoproteins. A study involving 517 patients over 96 weeks demonstrated significant reductions in LDL cholesterol, total cholesterol, triglycerides, and lipoprotein(a), along with an increase in HDL cholesterol. The medication was generally well-tolerated, with common side effects such as flushing decreasing over time[3].

Dose-Escalation Studies

Dose-escalation studies have further validated the efficacy of NIASPAN. Patients receiving escalating doses up to 3,000 mg/day showed dose-related improvements in their lipid profiles, including decreases in LDL cholesterol, triglycerides, and lipoprotein(a), and an increase in HDL cholesterol. However, side effects such as flushing and increases in liver enzymes were noted, although these were generally manageable[4].

Market Analysis

Global Nicotinic Acid Market

The global nicotinic acid market, which includes NIASPAN, is projected to grow significantly. By 2025, the market is estimated to be worth USD 362.4 million, increasing to USD 601.7 million by 2032. This growth is driven by the health benefits of nicotinic acid, including its role in cardiovascular disease prevention, skin protection, and brain function enhancement[2].

Vitamin B3 Market

The Vitamin B3 market, of which NIASPAN is a part, is expected to reach USD 373 million by 2025, growing at a CAGR of 2.5%. Key drivers include the demand for functional and nutritionally enriched food products, feed fortification, and the prevalence of Vitamin B3 deficiency[5].

Regional Demand

The demand for nicotinic acid is particularly high in the Asia Pacific region, driven by increasing health and fitness trends, higher disposable incomes, and a large youth population. This region is expected to boost the sales of nicotinic acid-containing products, including dietary supplements and pharmaceuticals[2].

Market Projections

Growth Factors

Several factors are expected to drive the growth of the NIASPAN market:

• Health Benefits: The proven efficacy of nicotinic acid in managing lipid profiles and reducing cardiovascular risk.
• Increasing Demand for Dietary Supplements: Rising awareness and demand for dietary supplements, especially among the youth population.
• Expanding Applications: Use in pharmaceuticals, cosmetics, animal nutrition, and food products.
• Regional Growth: Strong demand in the Asia Pacific region due to health and fitness trends[2][5].

Challenges

Despite the positive projections, there are challenges to consider:

• Side Effects: Common side effects such as flushing and potential liver enzyme elevations may affect patient compliance.
• Clinical Trial Outcomes: The mixed results from clinical trials, such as the AIM-HIGH study, may impact the perception and prescription of NIASPAN.
• Competition: The presence of other lipid-modifying drugs and the development of new treatments could compete with NIASPAN in the market[1][3][4].

Key Players

The nicotinic acid market, including NIASPAN, is dominated by several key players:

• Koninklijke DSM N.V
• Jubiliant Life Science Ingredients
• Lonza Group AG
• Aarti Drugs Ltd
• Vertellus
• Lasons India Pvt. Ltd
• Resonance Specialities Limited
• Brother Enterprises Holding Co. Ltd
• Triveni Chemicals

These companies are expected to continue innovating and expanding their product lines to meet the growing demand for nicotinic acid[2].

Key Takeaways

• Clinical Efficacy: NIASPAN has shown efficacy in long-term studies as monotherapy for lipid profile management, despite mixed results in combination therapy trials.
• Market Growth: The global nicotinic acid market is projected to grow significantly, driven by health benefits and increasing demand for dietary supplements.
• Regional Trends: The Asia Pacific region is expected to be a key driver of growth due to health and fitness trends.
• Challenges: Side effects and mixed clinical trial outcomes may impact market performance.
• Key Players: Several major companies are involved in the production and distribution of nicotinic acid products.

FAQs

What is NIASPAN used for?

NIASPAN is used to manage lipid profiles by reducing LDL cholesterol, triglycerides, and lipoprotein(a), and increasing HDL cholesterol.

What were the findings of the AIM-HIGH trial?

The AIM-HIGH trial found that NIASPAN, when combined with statins, did not reduce the incidence of heart attacks, strokes, or other cardiovascular events, despite improving lipid profiles.

What are the common side effects of NIASPAN?

Common side effects include flushing, which tends to decrease over time, and potential increases in liver enzymes.

Which regions are driving the growth of the nicotinic acid market?

The Asia Pacific region is a significant driver due to increasing health and fitness trends and a large youth population.

Who are the key players in the nicotinic acid market?

Key players include Koninklijke DSM N.V, Jubiliant Life Science Ingredients, Lonza Group AG, and others.

Sources

1. Fierce Pharma: "Abbott down after NIH halts Niaspan study"
2. Future Market Insights: "Nicotinic Acid Market Sales, Share, Trend & Analysis Report 2032"
3. PubMed: "Efficacy and safety of an extended-release niacin (Niaspan)"
4. PubMed: "Clinical trial experience with extended-release niacin (Niaspan)"
5. MarketsandMarkets: "Vitamin B3 Market Size & Share, Industry Statistics and Forecast to 2025"