Niacor (Niacin) - Summary

NIACOR SUMMARY

Niacin or nicotinic acid, a water-soluble B-complex vitamin and antihyperlipidemic agent, is 3-pyridinecarboxylic acid. It is a white, crystalline powder, sparingly soluble in water.

Niacor is indicated for the following:

I. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Nicotinic acid, alone or in combination with a bile-acid binding resin, is indicated as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Types IIa and IIb)^†, 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 guidelines⁶). Prior to initiating therapy with nicotinic acid, 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 performed to measure total cholesterol, HDL cholesterol, and triglycerides.

II. Nicotinic acid is also indicated as adjunctive therapy for the treatment of adult patients with very high serum triglyceride levels (Types IV and V hyperlipidemia)^† 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 triglyceride levels over 2000 mg/dL and have elevations of VLDL cholesterol as well as fasting chylomicrons (Type V hyperlipidemia)^†. Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to develop pancreatitis. Therapy with nicotinic acid may be considered for those subjects with triglyceride 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 triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of nicotinic acid therapy on the 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 triglycerides, but who have normal levels of VLDL. Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia⁷.

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NEWS HIGHLIGHTS

Media Articles Related to Niacor (Niacin)

Abbott Seeks FDA Approval Of New Dosage Strengths Of SIMCOR® (niacin Extended-release/simvastatin)
Source: Cholesterol News From Medical News Today [2009.12.12]
Abbott has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR®, a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin...

Abbott Seeks FDA Approval Of New Dosage Strengths Of SIMCOR(R) (niacin Extended-release/simvastatin)
Source: Cholesterol News From Medical News Today [2009.12.11]
Abbott (NYSE: ABT) has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR®, a cholesterol medication. SIMCOR is a fixed-dose combination of niacin extended-release and simvastatin...

Niacin Adds No Benefit for Statin Patients: Study
Source: MedicineNet atorvastatin Specialty [2009.12.03]
Title: Niacin Adds No Benefit for Statin Patients: Study
Category: Health News
Created: 12/3/2009 10:07:00 AM
Last Editorial Review: 12/3/2009 10:07:15 AM

Vitamin B Niacin Offers No Additional Benefit To Statin Therapy In Seniors Already Diagnosed With Coronary Artery Disease
Source: Statins News From Medical News Today [2009.11.19]
The routine prescription of extended-release niacin, a B vitamin (1,500 milligrams daily), in combination with traditional cholesterol-lowering therapy offers no extra benefit in correcting arterial narrowing and diminishing plaque buildup in seniors who already have coronary artery disease, a new vascular imaging study from Johns Hopkins experts shows...

Niacin And Niacinamide (Vitamin B3)
Source: MedicineNet Cholera Specialty [2009.01.27]
Title: Niacin And Niacinamide (Vitamin B3)
Category: Vitamins and Supplements
Created: 1/27/2009 4:00:00 PM
Last Editorial Review: 1/27/2009 4:00:06 PM

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Published Studies Related to Niacor (Niacin)

Flushing profile of extended-release niacin/laropiprant versus gradually titrated niacin extended-release in patients with dyslipidemia with and without ischemic cardiovascular disease. [2009.07.01]
Niacin has beneficial effects on a patient's lipid and lipoprotein profiles and cardiovascular risk, particularly at doses >2 g/day, but is underused due to flushing. Laropiprant (LRPT), a selective prostaglandin D(2) receptor-1 antagonist, decreases flushing associated with extended-release niacin (ERN)...

Effects of extended-release niacin on lipid profile and adipocyte biology in patients with impaired glucose tolerance. [2009.07]
CONCLUSION: Treatment with ER niacin significantly improves atherogenic lipid profile in patients with IGT. These beneficial effects could at least in part be due to pleiotropic niacin effects in adipose tissue, characterized by decreased mean adipocyte size, increased insulin sensitivity and altered mRNA expression profile.

Effects of oral niacin on endothelial dysfunction in patients with coronary artery disease: results of the randomized, double-blind, placebo-controlled INEF study. [2009.05]
High-density-lipoproteins-cholesterol (HDL-C) is invertedly related to the incidence of cardiovascular events... The present findings indicate that ER-niacin treatment improves endothelial dysfunction in patients with CAD and low HDL-C, but not with normal HDL-C.

Atheroprotective lipoprotein effects of a niacin-simvastatin combination compared to low- and high-dose simvastatin monotherapy. [2009.04]
BACKGROUND: Niacin has multiple lipoprotein effects that may provide cardiovascular benefit when added to statin monotherapy... CONCLUSIONS: We demonstrate that full-dose niacin/moderate-dose simvastatin combination has sustained benefits on atherogenic apoB lipoproteins, at least comparable to high-dose simvastatin, while also raising HDL-cholesterol. Results of large clinical trials will inform whether niacin-statin combinations reduce cardiovascular disease events.

Effects of aspirin when added to the prostaglandin D2 receptor antagonist laropiprant on niacin-induced flushing symptoms. [2009.04]
Niacin is an effective lipid-modifying therapy whose use has been limited by suboptimal tolerability... Coadministration of aspirin 325 mg daily with ER niacin 2 g/laropiprant 40 mg does not further reduce residual flushing symptoms associated with ER niacin 2 g/laropiprant 40 mg alone.

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Clinical Trials Related to Niacor (Niacin)

MK0524A Clinical Efficacy Study [Completed]
A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

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.

Evaluation of the Effect of NICOtinic Acid (Niacin) on Elevated Lipoprotein(a) Levels (NICOLa Study) [Recruiting]
Lipoprotein (Lp)(a) has been associated with increased risk of cardiovascular disease. Niacin has been shown to lower Lp(a) in patients with normal or moderately elevated levels. However, there are few studies assessing the effectiveness of niacin in Lp(a) levels above 30 mg/dl. In addition, most studies investigating the effectiveness of niacin have only included small numbers of patients. Also, Lp(a) was only assessed as a secondary endpoint. The aim of the present study was, therefore, to evaluate whether Niacin is effective compared to placebo in the reduction of an elevated Lp(a).

Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia [Completed]
Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome) are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle size, so often fenofibrate is added. This combination may still not be sufficient. Niacin is a common third drug added to the treatment regimen, but niacin can increase insulin resistance. This study compares niacin as a third drug to rosiglitazone, an insulin sensitizer.

Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL [Completed]
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.

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PATIENT REVIEWS / RATINGS / COMMENTS

Niacor review by 54 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		high cholesterol
Dosage & duration:		100 mg gradually increasing to 400 mg taken three times a day for the period of 4 days
Other conditions:		osteoporosis
Other drugs taken:		fosamax
		Reported Results
Benefits:		I was not willing to deal with the effects of the drug three times a day and so I discontinued use.
Side effects:		There were no side effects -- but the expected effects were very intense -- a hot flush that moved from my face to my legs, and itching on my arms, legs, back, and torso.
Comments:		Niacin taken in such a large dose opens the capillaries. This increases the blood flow close to the skin and releases histamines. The resulting hot flush and itching lasts for about 15 minutes. It is an interesting experience, but three times a day is a bit much, especially during my at work dose. The red face was alarming my customers and the itching was a bit too distracting.