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Niaspan (Niacin Extended-Release) - Summary

 
 



NIASPAN SUMMARY

NIASPAN® (niacin extended-release tablets), contain niacin, a B-complex vitamin and 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 hypercholesterolemia. 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 (see also the NCEP treatment guideline8; Table 11). Prior to initiating therapy with niacin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile obtained to measure TC, HDL-C, and TG.

  1. NIASPAN is indicated as an adjunct to diet for reduction of elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb; Table 12), when the response to an appropriate diet has been inadequate.
  2. NIASPAN in combination with lovastatin is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb; Table 12) in:
    • Patients treated with lovastatin who require further TG-lowering or HDL-raising who may benefit from having niacin added to their regimen
    • Patients treated with niacin who require further LDL-lowering who may benefit from having lovastatin added to their regimen
      Combination therapy is not indicated as initial therapy. (See DOSAGE AND ADMINISTRATION.)
  3. In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
  4. In patients with a history of coronary artery disease (CAD) and hypercholesterolemia, 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 as an adjunct to diet for reduction of elevated TC and LDL-C levels in adult patients with primary hypercholesterolemia (Type IIa; Table 12), when the response to an appropriate diet, or diet plus monotherapy, has been inadequate.
  6. Niacin is also indicated as adjunctive therapy for treatment of adult patients with very high serum triglyceride levels (Types IV and V hyperlipidemia; Table 12) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Such patients typically have serum TG levels over 2000 mg/dL and have elevations of VLDL-C as well as fasting chylomicrons (Type V hyperlipidemia; Table 12). Patients who consistently have total serum or plasma TG below 1000 mg/dL are unlikely to develop pancreatitis. Therapy with niacin may be considered for those patients with TG elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. Some Type IV patients with TG under 1000 mg/dL may, through dietary or alcohol indiscretion, convert to a Type V pattern with massive TG elevations accompanying fasting chylomicronemia, but the influence of niacin therapy on risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma TG, but who have normal levels of VLDL-C. Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia.9


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NEWS HIGHLIGHTS

Published Studies Related to Niaspan (Niacin Extended-Release)

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.

Safety, tolerance, and efficacy of extended-release niacin monotherapy for treating dyslipidemia risks in persons with chronic tetraplegia: a randomized multicenter controlled trial. [2011.03]
OBJECTIVE: To test the safety, tolerance, and efficacy of extended-release niacin monotherapy on dyslipidemia in persons with chronic tetraplegia... CONCLUSIONS: Extended-release niacin monotherapy is safe, tolerated, and effective for most persons with chronic tetraplegia. Special precautions for changes in bowel habits and postadministration hypotension should be observed. Copyright (c) 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Combination of niacin extended-release and simvastatin results in a less atherogenic lipid profile than atorvastatin monotherapy. [2010.11.24]
OBJECTIVE: To compare the effects of combination niacin extended-release + simvastatin (NER/S) versus atorvastatin alone on apolipoproteins and lipid fractions in a post hoc analysis from SUPREME, a study which compared the lipid effects of niacin extended-release + simvastatin and atorvastatin in patients with hyperlipidemia or mixed dyslipidemia... CONCLUSION: NER/S treatment significantly improved apo A-I levels and the apo B:A-I ratio, significantly lowered the number of atherogenic LDL particles and VLDL and chylomicron particles, and increased the mean size of LDL and VLDL particles, compared with atorvastatin.

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Clinical Trials Related to Niaspan (Niacin Extended-Release)

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

A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites [Completed]
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a specific metabolite (which is a marker of in vivo platelet reactivity).

Niacin, N-3 Fatty Acids and Insulin Resistance [Active, not recruiting]
This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.

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.

Flexible Doses of Niacin (Niaspan) as an Adjunct to Antipsychotic Medication in the Treatment of First Episode Psychosis [Recruiting]
Cognitive deficits, including impairments in areas such as memory, attention, and executive function, are a major determinant and predictor of long-term disability in schizophrenia.

Individuals with cognitive impairment have poorer psychosocial outcomes, including work, social skills, and self care.

A major objective of the proposed research will be to extend previous findings of enhanced function and neuroprotective effects of niaspan administration in first episode psychosis patients.

The primary objective of this study is to evaluate the impact of niaspan as an adjunct to antipsychotic medication versus antipsychotic medication alone on cognitive, symptomatic and functional outcomes in the treatment of first episode psychosis patients.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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

  Rating
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

  Rating
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: 2013-02-10

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