Niaspan

Name: Niaspan

Niaspan Overview

Niaspan is a prescription medication used to lower cholesterol and fats (triglycerides) in the blood. It can also help raise the amount of HDL ("good") cholesterol in the blood. Niaspan should be used in conjuction with a low-fat and low-cholesterol diet. Sometimes, Niaspan is taken with other cholesterol-lowering medications.

Niaspan is a B-complex vitamin, which may work by increasing the breakdown and removal of certain fats in the blood by increasing the activity of a certain enzyme.

Niaspan comes in an extended-release tablet and is usually taken once daily, at night, with a low-fat snack. Swallow Niaspan tablets whole. 

Common side effects of Niaspan include warmth and redness of the face (flushing), itching, rash, diarrhea, nausea, vomiting, and cough.

Niaspan may cause dizziness and blurred vision. Do not drive or operate heavy machinery until you know how Niaspan affects you.

Side Effects of Niaspan

Serious side effects have been reported with Niaspan. See the "Niaspan Precautions" section.

Common side effects of Niaspan include:

  • flushing
  • rash
  • diarrhea
  • nausea
  • vomiting
  • increased cough

Flushing is the most common side effect of Niaspan. Flushing happens when tiny blood vessels near the surface of the skin (especially on the face, neck, chest and/or back) open wider. Symptoms of flushing may include any or all of the following:

  • warmth
  • redness
  • itching
  • tingling of the skin

Flushing does not always happen. If it does, it is usually within 2 to 4 hours after taking a dose of Niaspan. Flushing may last for a few hours. Flushing is more likely to happen when you first start taking Niaspan or when your dose of Niaspan is increased. Flushing may get better after several weeks.

If you wake up at night because of flushing, get up slowly, especially if you:

  • feel dizzy or faint
  • take blood pressure medicines

To lower your chance of flushing:

  • Ask your doctor if you can take aspirin to help lower the flushing side effect from Niaspan. You can take aspirin (up to the recommended dose of 325 mg) about 30 minutes before you take Niaspan to help lower the flushing side effect.
  • Do not drink hot beverages (including coffee), alcohol, or eat spicy foods around the time you take Niaspan.
  • Take Niaspan with a low-fat snack to lessen upset stomach.

These are not all the possible side effects of Niaspan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Niaspan Food Interactions

Avoid ingestion of alcohol, hot beverages, and spicy foods around the time you take Niaspan to minimize flushing.

Niaspan Dosage

Take Niaspan exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication

The recommeded dose range of Niaspan for the treatment of high cholesterol is 500 mg to 2000 mg once daily. The maximum recommended dose of Niaspan is 2000 mg daily.

Dosage Forms and Strengths

  • 500 mg unscored, medium-orange, film-coated, capsule-shaped tablets
  • 750 mg unscored, medium-orange, film-coated, capsule-shaped tablets
  • 1000 mg unscored, medium-orange, film-coated, capsule-shaped tablets

Overdosage

Supportive measures should be undertaken in the event of an overdose.

Nonclinical Toxicology

Carcinogenesis and Mutagenesis and Impairment of Fertility

Niacin administered to mice for a lifetime as a 1% solution in drinking water was not carcinogenic. The mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined on a mg/m2 basis. Niacin was negative for mutagenicity in the Ames test. No studies on impairment of fertility have been performed. No studies have been conducted with Niaspan regarding carcinogenesis, mutagenesis, or impairment of fertility.

Clinical Studies

Niacin Clinical Studies

Niacin’s ability to reduce mortality and the risk of definite, nonfatal myocardial infarction (MI) has been assessed in long-term studies. The Coronary Drug Project, completed in 1975, was designed to assess the safety and efficacy of niacin and other lipid-altering drugs in men 30 to 64 years old with a history of MI. Over an observation period of 5 years, niacin treatment was associated with a statistically significant reduction in nonfatal, recurrent MI. The incidence of definite, nonfatal MI was 8.9% for the 1,119 patients randomized to nicotinic acid versus 12.2% for the 2,789 patients who received placebo (p<0.004). Total mortality was similar in the two groups at 5 years (24.4% with nicotinic acid versus 25.4% with placebo; p=N.S.). At the time of a 15-year follow-up, there were 11% (69) fewer deaths in the niacin group compared to the placebo cohort (52.0% versus 58.2%; p=0.0004). However, mortality at 15 years was not an original endpoint of the Coronary Drug Project. In addition, patients had not received niacin for approximately 9 years, and confounding variables such as concomitant medication use and medical or surgical treatments were not controlled.

The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a randomized, placebo-controlled, angiographic trial testing combined colestipol and niacin therapy in 162 non-smoking males with previous coronary bypass surgery. The primary, per-subject cardiac endpoint was global coronary artery change score. After 2 years, 61% of patients in the placebo cohort showed disease progression by global change score (n=82), compared with only 38.8% of drug-treated subjects (n=80), when both native arteries and grafts were considered (p<0.005); disease regression also occurred more frequently in the drug-treated group (16.2% versus 2.4%; p=0.002). In a follow-up to this trial in a subgroup of 103 patients treated for 4 years, again, significantly fewer patients in the drug-treated group demonstrated progression than in the placebo cohort (48% versus 85%, respectively; p<0.0001).

The Familial Atherosclerosis Treatment Study (FATS) in 146 men ages 62 and younger with Apo B levels ≥125 mg/dL, established coronary artery disease, and family histories of vascular disease, assessed change in severity of disease in the proximal coronary arteries by quantitative arteriography. Patients were given dietary counseling and randomized to treatment with either conventional therapy with double placebo (or placebo plus colestipol if the LDL-C was elevated); lovastatin plus colestipol; or niacin plus colestipol. In the conventional therapy group, 46% of patients had disease progression (and no regression) in at least one of nine proximal coronary segments; regression was the only change in 11%. In contrast, progression (as the only change) was seen in only 25% in the niacin plus colestipol group, while regression was observed in 39%. Though not an original endpoint of the trial, clinical events (death, MI, or revascularization for worsening angina) occurred in 10 of 52 patients who received conventional therapy, compared with 2 of 48 who received niacin plus colestipol.

Niaspan Clinical Studies

Placebo-Controlled Clinical Studies in Patients with Primary Hyperlipidemia and Mixed Dyslipidemia: In two randomized, double-blind, parallel, multi-center, placebo-controlled trials, Niaspan dosed at 1000, 1500 or 2000 mg daily at bedtime with a low-fat snack for 16 weeks (including 4 weeks of dose escalation) favorably altered lipid profiles compared to placebo (Table 3). Women appeared to have a greater response than men at each Niaspan dose level (see Gender Effect, below).

Table 3. Lipid Response to Niaspan Therapy
    Mean Percent Change from Baseline to Week 16*
Treatment n TC LDL-C HDL-C TG Apo B
Niaspan 1000 mg at bedtime 41 -3 -5 +18 -21 -6
Niaspan 2000 mg at bedtime 41 -10 -14 +22 -28 -16
Placebo 40 0 -1 +4 0 +1
Niaspan 1500 mg at bedtime 76 -8 -12 +20 -13 -12
Placebo 73 +2 +1 +2 +12 +1
n = number of patients at baseline;
* Mean percent change from baseline for all Niaspan doses was significantly different (p < 0.05) from placebo.

In a double-blind, multi-center, forced dose-escalation study, monthly 500 mg increases in Niaspan dose resulted in incremental reductions of approximately 5% in LDL-C and Apo B levels in the daily dose range of 500 mg through 2000 mg (Table 4). Women again tended to have a greater response to Niaspan than men (see Gender Effect, below).

Table 4. Lipid Response in Dose-Escalation Study
    Mean Percent Change from Baseline*
Treatment n TC LDL-C HDL-C TG Apo B
Placebo‡ 44 -2 -1 +5 -6 -2
Niaspan 87          
   500 mg at bedtime   -2 -3 +10 -5 -2
  1000 mg at bedtime   -5 -9 +15 -11 -7
  1500 mg at bedtime   -11 -14 +22 -28 -15
   2000 mg at bedtime   -12 -17 +26 -35 -16
n = number of patients enrolled;
‡ Placebo data shown are after 24 weeks of placebo treatment.
* For all Niaspan doses except 500 mg, mean percent change from baseline was significantly different (p < 0.05) from placebo for all lipid parameters shown.

Pooled results for major lipids from these three placebo-controlled studies are shown below (Table 5).

Table 5. Selected Lipid Response to Niaspan in Placebo-Controlled Clinical Studies*
 

Mean Baseline and Median Percent Change from Baseline
(25th, 75th Percentiles)

Niaspan
Dose

n LDL-C HDL-C TG
1000 mg at bedtime 104      
   Baseline (mg/dL)   218 45 172
      Percent Change   -7 (-15, 0) +14 (+7, +23) -16 (-34, +3)
1500 mg at bedtime 120      
   Baseline (mg/dL)   212 46 171
      Percent Change   -13 (-21, -4) +19 (+9, +31) -25 (-45, -2)
2000 mg at bedtime 85      
   Baseline (mg/dL)   220 44 160
      Percent Change   -16 (-26, -7) +22 (+15, +34) -38 (-52, -14)
* Represents pooled analyses of results; minimum duration on therapy at each dose was 4 weeks.

Gender Effect: Combined data from the three placebo-controlled Niaspan studies in patients with primary hyperlipidemia and mixed dyslipidemia suggest that, at each Niaspan dose level studied, changes in lipid concentrations are greater for women than for men (Table 6).

Table 6. Effect of Gender on Niaspan Dose Response
    Mean Percent Change from Baseline
Niaspan n LDL-C HDL-C TG Apo B
Dose (M/F) M F M F M F M F
500 mg at bedtime 50/37 -2 -5 +11 +8 -3 -9 -1 -5
1000 mg at bedtime 76/52 -6* -11* +14 +20 -10 -20 -5* -10*
1500 mg at bedtime 104/59 -12 -16 +19 +24 -17 -28 -13 -15
2000 mg at bedtime 75/53 -15 -18 +23 +26 -30 -36 -16 -16
n = number of male/female patients enrolled.
* Percent change significantly different between genders (p < 0.05).

Other Patient Populations: In a double-blind, multi-center, 19-week study the lipid-altering effects of Niaspan (forced titration to 2000 mg at bedtime) were compared to baseline in patients whose primary lipid abnormality was a low level of HDL-C (HDL-C ≤40 mg/dL, TG ≤400 mg/dL, and LDL-C ≤160, or <130 mg/dL in the presence of CHD). Results are shown below (Table 7).

Table 7. Lipid Response to Niaspan in Patients with Low HDL-C
  Mean Baseline and Mean Percent Change from Baseline*
  n TC LDL-C HDL-C TG Apo B†
Baseline
   (mg/dL)
88 190 120 31 194 106
Week 19
   (% Change)
71 -3 0 +26 -30 -9
n = number of patients
* Mean percent change from baseline was significantly different (p < 0.05) for all lipid parameters shown except LDL-C.
† n = 72 at baseline and 69 at week 19.

At Niaspan 2000 mg/day, median changes from baseline (25th, 75th percentiles) for LDL-C, HDL-C, and TG were -3% (-14, +12%), +27% (+13, +38%), and -33% (-50, -19%), respectively.

What should I avoid?

Avoid drinking hot beverages shortly after taking Niaspan ER. Hot drinks can worsen the flushing effect (warmth, itching, redness, or tingly feeling under your skin).

Avoid drinking alcohol while taking Niaspan ER. Alcohol may increase your risk of liver damage, and can also worsen the flushing effects of this medicine.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take Niaspan ER. If you take either of these other medications, take them at least 4 to 6 hours before or after you take Niaspan ER.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

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