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Niaspan (Niacin Extended-Release) - Summary



NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent.

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

  1. NIASPAN is indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
  2. NIASPAN in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with NIASPAN, simvastatin, or lovastatin monotherapy is considered inadequate.
  3. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
  4. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
  5. NIASPAN in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
  6. Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.

Limitations of Use

No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.

NIASPAN, at doses of 1,500-2,000 mg/day, in combination with simvastatin, did not reduce the incidence of cardiovascular events more than simvastatin in a randomized controlled trial of patients with cardiovascular disease and mean baseline LDL-C levels of 74 mg per deciliter. [see Warnings and Precautions ]

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Published Studies Related to Niaspan (Niacin Extended-Release)

Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. [2013]
CONCLUSIONS: These results suggest that E/S+N improves lipoprotein particle

MRI-measured regression of carotid atherosclerosis induced by statins with and without niacin in a randomised controlled trial: the NIA plaque study. [2013]
plaque regression among older individuals with established atherosclerosis... CONCLUSIONS: Treatment with statin therapy to presently recommended LDL levels,

Extended-release niacin acutely suppresses postprandial triglyceridemia. [2012]
triglycerides are related to free fatty acid restriction... CONCLUSIONS: Given right before a fat meal, even a single dose of

Extended-release niacin/laropiprant lowers serum phosphorus concentrations in patients with type 2 diabetes. [2011.07]
BACKGROUND: Niacin compounds lower serum phosphorus concentrations in patients with end-stage renal disease. METHODOLOGY: We evaluated the impact of extended release niacin, given in fixed-dose combination with laropiprant, a specific inhibitor of prostaglandin-mediated, niacin-induced flushing, versus placebo, on serum phosphorus concentrations measured serially (at weeks 0, 4, 8, 12, 18, 24, 30, and 36) during a 36-week randomized, controlled trial...

Assessment of potential pharmacokinetic interactions of ezetimibe/simvastatin and extended-release niacin tablets in healthy subjects. [2011.05]
BACKGROUND: Efforts to lower plasma lipid levels sometimes require multiple agents with different mechanisms of action to achieve results specified by national treatment guidelines... CONCLUSION: There is a small pharmacokinetic drug interaction between ER niacin and ezetimibe/simvastatin and although this is not considered to be clinically significant, the concomitant use of these drugs should be appropriately monitored, especially during the niacin titration period.

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Clinical Trials Related to Niaspan (Niacin Extended-Release)

Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2) [Completed]
This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment spans 7 days

Biosynthesis of PGD2 in Vivo [Completed]
We would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin. Phase I: 5 days of 81 mg aspirin/placebo followed by 600 mg Niacin, 2 week washout and 5 days taking the alternate. The order in which this is given will be randomized or assigned by chance. Phase II: One study week consisting of 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Phase III: 5 days taking 81 mg Aspirin/placebo, 10 day washout in between. Phase IV: Use of extended release niacin instead of instant release. Phase V: A Celebrex study is necessary to explore the contribution of Cox-2 to niacin induced flushing.

Niacin on Immune Activation : a Proof-of-concept Study [Active, not recruiting]
There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels and enable HIV-infected individuals to live longer. However, some participants taking anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing AIDS and non-AIDS-related complications. ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3. Niacin is effective in reducing cholesterol levels in the blood. This drug has been known for a long-time to treat dyslipidemia and it is used to improve favourably all the lipoprotein risk factors for artherosclerotic disease, particularly in HIV-infected patients. Recent scientific research shows that regular consumption of niacin-rich foods may also provide protection against Alzheimer's disease and age-related cognitive decline. The purpose of this study is to find out: 1. If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could reduce T cell immune activation and enhance CD4 recovery; 2. If ER niacin can improve your quality of life and your neurocognitive functions

Comparison of TRIA-662 500 mg and Niaspan 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions [Completed]
The objective of this study is to compare the absorption of a niacin metabolite (1-methylnicotinamide, 1-MNA) from TRIA-662 (1-methylnicotinamide chloride)relative to the production of 1-MNA from Niaspan. The 1-MNA information obtained from this study will be used to adjust the top dose of a planned TRIA-622 efficacy study.

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients [Recruiting]
The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.

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Reports of Suspected Niaspan (Niacin Extended-Release) Side Effects

Flushing (2478)Pruritus (959)Feeling Hot (698)Erythema (581)Paraesthesia (581)Skin Burning Sensation (257)Burning Sensation (209)Blood Glucose Increased (172)Hot Flush (153)Headache (146)more >>


Based on a total of 11 ratings/reviews, Niaspan has an overall score of 7.73. The effectiveness score is 8.18 and the side effect score is 7.27. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Niaspan review by 62 year old male patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   high total cholesterol
Dosage & duration:   2000mg/day taken once a day for the period of 3 years
Other conditions:   barrets syndrome, mild situational depression
Other drugs taken:   Nexium, Wellbutrin
Reported Results
Benefits:   The medication reduced total cholesterol from about 220 to about 180. blood pressure appeared to slightly decrease from 125/70 to 115/65. The ration between high density cholesterol (good cholesterol) to low density cholesterol improved significantly.
Side effects:   Initially has hot flashes red flushing of skin. However it was discovered that taking the Niaspan before going to bed, with an 81mg enteric coated aspirin entirely eliminated the hot flashes. There have been some deposits of fatty nodules just below the skin in several locations. There has not been a causative link between the Niaspan pointed out to me. However since the Niaspan reduces the circulating amount of a fatty chemical, the appearance of fatty deposits is suspicious.
Comments:   Two pills, 1000mg per pill, taken in the evening, with an 81mg enteric aspirin. It is suggested that no high fat-foods be eaten several hours before taking the Niaspan, since there appears to be some relationship between high fat meals and hot flashes.


Niaspan review by 49 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   low hdl
Dosage & duration:   1000 mg taken 1/day for the period of 7 months
Other conditions:   low ldl
Other drugs taken:   none
Reported Results
Benefits:   my hdl has gone up. i am still taking niaspan and feel like it is helping.
Side effects:   i did have some flushing at first...however that did not last very long, nor were the symptons too bad. other than that i have had no side effects
Comments:   i take 1 1000 mg pill every night. along with the medication i have improved my diet, lowered my fat consupmtion and added 30 mins of walking every day. I feel the niaspan has helped my hdl blood count considerable.


Niaspan review by 62 year old female patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   high colestrol
Dosage & duration:   1000 mg taken once per day for the period of 4 months
Other conditions:   coronary heart disease
Other drugs taken:   diovan
Reported Results
Benefits:   none so far
Side effects:   terrible flushing..itching is now constant...breaking out with white bumps on my hands and change in skin texture on whole body. Left ankle swells. Feels like a lump or obstruction in throat. Chest discomfort. Shortness of breath at times.
Comments:   Started at 500mg with most of the symptoms, increased to 1000mg and developed constant itching and skin disorders

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Page last updated: 2014-11-30

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