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

Media Articles Related to Niaspan (Niacin Extended-Release)

AHA: Niacin Bests Ezetimibe as Add-On Therapy (CME/CE)
Source: MedPage Today Neurology [2009.11.15]
ORLANDO (MedPage Today) -- In high-risk patients on long-term statin therapy, boosting HDL cholesterol with extended-release niacin (Niaspan) is a more effective way of slowing atherosclerosis than going for additional LDL cholesterol reductions by adding ezetimibe (Zetia), researchers here reported.

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Published Studies Related to Niaspan (Niacin Extended-Release)

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.

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.

Blood pressure-lowering effects of extended-release niacin alone and extended-release niacin/laropiprant combination: a post hoc analysis of a 24-week, placebo-controlled trial in dyslipidemic patients. [2009.01]
CONCLUSION: This post hoc analysis of a 24-week trial found that ERN alone, or in combination with LRPT, was associated with significant placebo-adjusted reductions from baseline in blood pressure in these hyperlipidemic hypertensive or normotensive subjects.

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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 VYTORIN® (Ezetimibe and Simvastatin) and NIASPAN® (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.

SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia [Completed]
Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and together. This study will help show how the individual benefits of the two drugs taken separately can be combined when taken together.

Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function [Active, not recruiting]
AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients with established atherosclerosis. The investigators will therefore study patients with atherosclerosis in the aorta and carotid artery. Plaque quantification will be with magnetic resonance imaging (MRI).

AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with coronary artery disease and type II diabetes mellitus, who typically have low high-density lipoprotein cholesterol (HDL-C), and high risk of cardiovascular events.

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PATIENT REVIEWS / RATINGS / COMMENTS

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 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		high lpa
Dosage & duration:		1000 mg taken once a day for the period of two years
Other conditions:		high cholesterol
Other drugs taken:		lipitor
		Reported Results
Benefits:		Niaspan definitely works to lower lpa. I understand that high lpa cause plaque build up in the arteries. According to my cardiologist, high levels of lpa cause "skinny people to have heart attacks". My levels were in the 70's and the normal range ends at 30. After taking Niaspan for a few weeks, my lpa was within normal limits.
Side effects:		Flushing with skin burning was the main side effect of taking 1000 mg of Niapsan per day. The cardiologist suggested taking a baby aspirin one halp hour before taking the Niaspan. This does eliminate most of the flushing side effects and skin burning. I highly recommend everyone with a family history of heart problems to get a blood test for lpa.
Comments:		1000 mg a day - once a day Cardiologist wanted me to take up to 1,500 mg but 1,000 mg brought my lpa back into range. My blood lpa test came back in the 70 range and normal limit is up to 30. After taking 1000 mg, I was back in the normal lpa range. Everyone with a family history of heart attacks or high cholesterol should have an lpa blood test run in order to prevent possible plaque buildup.

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.